venous thrombosis

Description Results NMA

DVT only 0.55 [0.31; 0.98]

recurrence of venous thromboembolism 0.63 [0.41; 0.97]

major vascular events 1.54 [0.51; 4.62]

death 1.15 [0.36; 3.72]

major bleeding 0.96 [0.06; 15.26]

fatal PE 0.96 [0.06; 15.26]

PE 0.76 [0.35; 1.62]

major and Clinically relevant nonmajor bleeding 0.96 [0.24; 3.79]

major vascular events 0.70 [0.52; 0.95]

net clinical benefit 0.72 [0.55; 0.94]

death 0.89 [0.46; 1.72]

major bleeding 1.75 [0.74; 4.13]

fatal PE 1.00 [0.06; 15.93]

PE 0.60 [0.34; 1.06]

DVT only 0.91 [0.60; 1.37]

major and Clinically relevant nonmajor bleeding 1.75 [0.74; 4.13]

recurrence of venous thromboembolism 0.78 [0.57; 1.07]

aspirin, 100 mg daily for 2 years (n=205)

vs.

placebo (n=197)

double-blind

Parallel groups

Sample size: 205/197

Primary endpoint: recurrence of venous thromboembolism

FU duration: 24.6 mo (median)

aspirin, at a dose of 100 mg daily up to 4 years (n=411)

vs.

(n=411)

Sample size: 411/411

Primary endpoint:

FU duration: 37.2 montsh (median)

VTE during active anticoagulant treatment 0.78 [0.19; 3.19]

LMWH, 115 IU/kg qd followed by Bemiparin 3,500 IU qd (n=221)

vs.

A: UFH, 30/40,000IU qd; B: LMWH, 115 IU/kg qd followed by Warfarin target INR 2-3 (n=103)

open

Sample size: 221/103

Primary endpoint: none defined

FU duration: 3 mo

Recurrent DVT/DVTextension (total) 0.51 [0.33; 0.79]

All-cause mortality 0.96 [0.79; 1.15]

deaths at 6 months 0.96 [0.79; 1.15]

Major hemorrhage 1.57 [0.77; 3.18]

Dalteparin 200 IU/kg daily for 1 month followed by 150 IU/kg daily for 5 months (n=-9)

vs.

Dalteparin 200 IU/kg daily for 5-7 days followed by wafarin or acecumarol (target INR 2-3) for 6 months (n=-9)

outcome assessment blinded

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration: 6 months

VTE during active anticoagulant treatment 2.75 [0.56; 13.55]

VTE during active anticoagulant treatment 0.51 [0.33; 0.79]

UFH followed by Dalteparin 5,000 IU qd (n=50)

vs.

UFH followed by Warfarin target INR 2-3 (n=55)

open

Sample size: 50/55

Primary endpoint: recurrent venous thromboembolism

FU duration: 3 mo

LMWH, 200 IU/kg qd followed by Dalteparin 150 IU/kg qd (n=336)

vs.

LMWH, 200 IU/kg qd followed by Warfarin target INR 2-3 (n=336)

open

Sample size: 336/336

Primary endpoint: recurrent thrombosis

FU duration: 6 mo

all cause death NaN [NaN; NaN]

Recurrent thromboembolic event NaN [NaN; NaN]

Thrombus extension 0.00 [0.00; NaN]

Short term haemorrhage ∞ [NaN; ∞]

all cause death NaN [NaN; NaN]

Recurrent thromboembolic event ∞ [NaN; ∞]

Thrombus extension 0.47 [0.04; 4.85]

Short term haemorrhage NaN [NaN; NaN]

all cause death 1.83 [0.72; 4.64]

Recurrent thromboembolic event 0.67 [0.20; 2.24]

Thrombus extension 0.67 [0.12; 3.85]

Short term haemorrhage 0.00 [0.00; NaN]

all cause death 0.68 [0.12; 3.98]

Recurrent thromboembolic event 2.04 [0.52; 7.93]

Thrombus extension 0.73 [0.24; 2.22]

Short term haemorrhage NaN [NaN; NaN]

Dalteparin Intravenousv (ajusted) for >=5 Days, 120 U/kg BID (n=25)

vs.

unfractionated heparin intravenous APPTx1.7-3.5 (n=29)

Sample size: 25/29

Primary endpoint:

FU duration: 23 Months (mean)

Dalteparin Subcutaneous twice daily ajusted for 7 Days, 57-107 U/kg BID (n=29)

vs.

unfractionated heparin subcutaneous twice daily 16000-30000 U (n=27)

Sample size: 29/27

Primary endpoint:

FU duration: Hospital Stay

Dalteparin Subcutaneous twice daily ajusted for >= 5 Days, 120 U/kg BID (n=60)

vs.

unfractionated heparin intravenous APPTx2-4 (n=60)

Sample size: 60/60

Primary endpoint:

FU duration: Hospital stay

Dalteparin Subcutaneous once daily for >= 5 Days, 200 U/kg BID (n=101)

vs.

unfractionated heparin intravenous APPTx1.5-3 (n=103)

Sample size: 101/103

Primary endpoint:

FU duration: 6 Months

Improvement of thrombus size 1.07 [0.72; 1.59]

Haemorraghic events 0.00 [0.00; NaN]

Mortality 2.53 [0.27; 23.70]

Haemorraghic events ∞ [NaN; ∞]

once daily dalteparin 200 U (anti-FXa)/kg for at least 5 days (n=50)

vs.

twice daily dalteparin 100 U (anti-FXa)/kg for at least 5 days (n=51)

open

Parallel groups

Sample size: 50/51

Primary endpoint:

FU duration:

Fragmin administered 200 IU/kg once daily for at least 7 days (n=76)

vs.

Fragmin 100 IU/kg twice daily for at least 7 days (n=64)

NA

Parallel groups

Sample size: 76/64

Primary endpoint:

FU duration:

Major hemorrhage 1.77 [1.03; 3.04]

recurrent venous thromboembolism or major bleeding 0.97 [0.70; 1.35]

All-cause mortality 1.12 [0.92; 1.37]

Recurrent DVT/DVT extension (symptomatic) 0.71 [0.48; 1.06]

recurrent VTE 0.71 [0.48; 1.06]

low-molecular-weight heparin for at least 5 days followed by oral edoxaban at a dose of 60 mg once daily. Treatment was given for atleast 6 months and up to 12 months. (n=522)

vs.

subcutaneous dalteparin at a dose of 200 IU per kilogram of body weight once daily for 1 month followed by dalteparin at a dose of 150 IU per kilogram once daily (n=524)

open label

Sample size: 522/524

Primary endpoint: recurrent venous thromboembolism or major bleeding at12 months

FU duration:

All-cause mortality 0.67 [0.11; 3.90]

Recurrent DVT/DVTextension (total) 0.66 [0.16; 2.74]

death at 3 months 0.67 [0.11; 3.90]

All-cause mortality 1.01 [0.56; 1.84]

deaths at 6 months 1.01 [0.56; 1.84]

Major hemorrhage 3.04 [0.38; 24.28]

All-cause mortality 0.80 [0.51; 1.26]

deaths at 6 months 0.80 [0.51; 1.26]

Major hemorrhage 0.44 [0.16; 1.19]

Recurrent DVT/DVTextension (total) 0.70 [0.12; 4.09]

Thrombocytopenia 0.94 [0.52; 1.69]

death at 3 months 0.50 [0.23; 1.08]

Enoxaparin 100UL/Kg twice daily for 3 months (n=-9)

vs.

coumadin (target INR 3) for 3 months. (n=-9)

NA

Parallel groups

Sample size: -9/-9

Primary endpoint: Death at 3 months

FU duration: 3 months

Enoxaparin 1mg/kg twice daily for 5 days followed by 1-1.5mg/kg daily for 175 days (n=-9)

vs.

Enoxaparin 1mg/kg twice daily for 5 days followed by warfarin (target INR 2-3) for a total of 180 days (n=-9)

none

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration: 12 months

Enoxaparin 1.5 mg/kg daily for 3 monthsmag (n=-9)

vs.

Enoxaparin 1.5 mg/kg daily for 4 days followed by warfarin (target INR 2-3) for 3 months (n=-9)

outcome assessment blinded

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration: 3 months

VTE during follow-up after active anticoagulant treatment 2.56 [0.83; 7.85]

VTE during active anticoagulant treatment 1.52 [0.44; 5.20]

VTE during active anticoagulant treatment 0.42 [0.19; 0.90]

VTE during follow-up after active anticoagulant treatment 1.25 [0.41; 3.82]

VTE during active anticoagulant treatment 2.00 [0.19; 21.36]

VTE during follow-up after active anticoagulant treatment ∞ [NaN; ∞]

VTE during active anticoagulant treatment 0.59 [0.09; 3.96]

VTE during active anticoagulant treatment 1.97 [1.06; 3.66]

UFH, APTT 1.3–1.9 followed by Enoxaparin 4,000 IU qd (n=93)

vs.

UFH, APTT 1.3–1.9 followed by Warfarin target INR 2-3.5 (n=94)

open

Sample size: 93/94

Primary endpoint: none defined

FU duration: 9 mo

LMWH, 4,000 IU bid followed by Enoxaparin 4,000 IU qd (n=93)

vs.

UFH followed by Warfarin target INR 2-3 (n=92)

open

Parallel groups

Sample size: 93/92

Primary endpoint: none defined

FU duration: 9 mo

UFH, APTT 1.5–2.0d followed by Enoxaparin 4,000 IU qd (n=50)

vs.

UFH, APTT 1.5–2.0d followed by Acenocoumarol target INR 2-3 (n=50)

open

Sample size: 50/50

Primary endpoint: none defined

FU duration: 6-9 mo

LMWH, 1.5 mg/kg qd followed by Enoxaparin 1.5 mg/Kg qd (n=71)

vs.

LMWH, 1.5 mg/kg qd followed by Warfarin target INR 2-3 (n=58)

open

Sample size: 71/58

Primary endpoint: major bleeding or recurrent venous thromboembolism

FU duration: 3 mo

LMWH: 1a, 1 mg/kg q12h; 1b, 1 mg/kg qd12h followed by Enoxaparin 1a: 1 mg/kg qd; 1b: 1.5 mg/kg qd (n=51)

vs.

LMWH, 1 mg/kg q12h followed by Warfarin target INR 2-3 (n=30)

open

Sample size: 51/30

Primary endpoint:

FU duration: 6 mo

long-term anticoagulant treatment with enoxaparin during at least 3 months (n=85)

vs.

long-term anticoagulant treatment with coumarin during at least 3 months (n=80)

open, blind assessment

Parallel groups

Sample size: 85/80

Primary endpoint: incidence of post-thrombotic syndrome

FU duration: 1y, 5y

all cause death 1.50 [0.26; 8.69]

Recurrent thromboembolic event 0.00 [0.00; NaN]

Thrombus extension 0.14 [0.02; 1.13]

Short term haemorrhage NaN [NaN; NaN]

Enoxaparin Subcutaneous twice daily for 0 Days, 100 U/kg BID (n=67)

vs.

unfractionated heparin intravenous APPTx1.5-2.5 (n=67)

Sample size: 67/67

Primary endpoint:

FU duration: 3 Months

Mortality 1.65 [0.65; 4.19]

Haemorraghic events 1.31 [0.35; 4.83]

Recurrent thromboembolic events 1.51 [0.66; 3.49]

enoxaparin 1.5 mg/kg body weight once daily (n=298)

vs.

S.c. enoxaparin at fixed dosages of 1.0 mg/kg of body weight twice daily (n=312)

double blind

Parallel groups

Sample size: 298/312

Primary endpoint:

FU duration:

Mortality 1.19 [0.50; 2.83]

Haemorraghic events 1.15 [0.77; 1.70]

Recurrent thromboembolic events 1.05 [0.49; 2.27]

Initial therapy with enoxaparin 1.5 mg/kg body weight once daily (n=298)

vs.

Initial therapy with dose-adjusted intravenous unfractionated heparin (n=290)

partialy blinded

Parallel groups

Sample size: 298/290

Primary endpoint: occurrence of symptomatic recurrent venous thromboembolism

FU duration: 3 months

Recurrent DVT/DVT extension (symptomatic) 0.96 [0.64; 1.45]

All-cause mortality 1.25 [0.80; 1.97]

Major hemorrhage 1.09 [0.64; 1.84]

Non-fatal PE 1.68 [0.83; 3.42]

Fatal PE 1.01 [0.29; 3.47]

fondaparinux 7.5 mg subcutaneously once daily for at least 5 days and until vitamin K antagonists induced an INR greater than 2.0. (n=1098)

vs.

enoxaparin, 1 mg/kg of body weight, subcutaneously twice daily for at least 5 days and until vitamin K antagonists induced an INR greater than 2.0. (n=1107)

double blind

Parallel groups

Sample size: 1098/1107

Primary endpoint: symptomatic recurrent venous thromboembolic

FU duration: 3 months

Fatal PE 1.09 [0.08; 15.42]

anticoagulants (s.c. heparin followed by oral warfarin) (duration NA) (n=11)

vs.

s.c. saline followed by oral placebo tablets (n=12)

double blind

Sample size: 11/12

Primary endpoint:

FU duration:

extension or recurrence of VTE 0.10 [0.01; 0.75]

major hemorrhage 0.25 [0.03; 2.16]

extension or recurrence of VTE 3.73 [1.10; 12.68]

major hemorrhage 1.02 [0.15; 6.98]

major hemorrhage 2.04 [0.39; 10.65]

extension or recurrence of VTE 1.02 [0.31; 3.31]

extension or recurrence of VTE 0.15 [0.04; 0.65]

major hemorrhage 1.00 [0.15; 6.82]

major hemorrhage 1.92 [0.18; 20.43]

extension or recurrence of VTE 0.27 [0.06; 1.25]

major hemorrhage 0.54 [0.18; 1.56]

extension or recurrence of VTE 1.93 [0.36; 10.35]

heparin and phenprocoumon for 3 months (n=48)

vs.

phenylbutazone (n=42)

open

Sample size: 48/42

Primary endpoint:

FU duration:

subcutaneous sodic heparin 30 000 U daily (mean) (n=23)

vs.

intravenous sodic heparin 30 000 U daily (mean) (n=25)

Sample size: 23/25

Primary endpoint:

FU duration:

subcutaneous calcic heparin 37 000 U daily (mean) (n=50)

vs.

intravenous sodic heparin 36 800 U daily (mean) (n=50)

Sample size: 50/50

Primary endpoint:

FU duration:

subcutaneous sodic heparin 36 800 U daily (mean) (n=72)

vs.

intravenous sodic heparin 33 250 U daily (mean) (n=69)

Sample size: 72/69

Primary endpoint:

FU duration:

subcutaneous sodic heparin 32 300 U daily (mean) (n=57)

vs.

intravenous sodic heparin 29 700 U daily (mean) (n=58)

Sample size: 57/58

Primary endpoint:

FU duration:

subcutaneous calcic heparin 29 200 U daily (mean) (n=51)

vs.

intravenous calcic heparin 29 600 U daily (mean) (n=52)

Sample size: 51/52

Primary endpoint:

FU duration:

subcutaneous calcic heparin 29 375 U daily (mean) (n=50)

vs.

intravenous calcic heparin 24 384 U daily (mean) (n=50)

Sample size: 50/50

Primary endpoint:

FU duration:

subcutaneous sodic heparin 34 400 U daily (mean) (n=48)

vs.

intravenous sodic heparin 37 000 U daily (mean) (n=46)

Sample size: 48/46

Primary endpoint:

FU duration:

subcutaneous calcic heparin 33 800 U daily (mean) (n=138)

vs.

intravenous sodic heparin 31 700 U daily (mean) (n=133)

Sample size: 138/133

Primary endpoint:

FU duration:

all bleeding 0.89 [0.50; 1.59]

deaths at 6 months 0.99 [0.66; 1.48]

Recurrent DVT/DVTextension (total) 0.38 [0.14; 1.06]

once-weekly subcutaneous injection of idraparinux (2.5 mg) for 6 months (n=220)

vs.

standard treatment for three months (8%) or six months (92%) (n=201)

Parallel groups

Sample size: 220/201

Primary endpoint:

FU duration: 6 months

Improvement of thrombus size 2.00 [0.68; 5.85]

Mortality NaN [NaN; NaN]

Haemorraghic events NaN [NaN; NaN]

Recurrent thromboembolic events NaN [NaN; NaN]

Once daily logiparin 150 XaI U/kgp, imag (n=10)

vs.

twice daily logiparin 75 XaI U/kg (n=10)

single blind

Parallel groups

Sample size: 10/10

Primary endpoint:

FU duration:

All-cause mortality 1.24 [0.52; 2.94]

Nadroparin 1.025 antiXa IU/10Kg twice daily after aadroparin 1.025AXa IU/10Kg twice daily for 3 days. After 3 months, nadroparin was switched to once daily (n=-9)

vs.

acenocoumarol (target INR 2-3) for 3-6 months after nadroparin 1.025AXa IU/10Kg twice daily for 3 days (n=-9)

outcome assessment blinded

Parallel groups

Sample size: -9/-9

Primary endpoint: Death at 12 months

FU duration: 12 months

VTE during follow-up after active anticoagulant treatment 2.53 [0.50; 12.71]

VTE during active anticoagulant treatment 0.43 [0.11; 1.61]

VTE during follow-up after active anticoagulant treatment 0.50 [0.09; 2.65]

VTE during active anticoagulant treatment 2.85 [0.80; 10.14]

LMWH, 85 UI/kg bid followed by Nadroparin 85 IU/kg qd (n=101)

vs.

LMWH, 85 UI/kg bid followed by Acenocoumarol target INR 2-3 (n=101)

open

Sample size: 101/101

Primary endpoint: none defined

FU duration: 9 mo

LMWH, 1,025 IU/10 kg bid followed by Nadroparin 1,025 IU/10 kg bid (n=81)

vs.

LMWH, 1,025 IU/10 kg bid followed by Acenocoumarol target INR 2-3 (n=77)

open

Sample size: 81/77

Primary endpoint: none defined

FU duration: 6-9 mo

all cause death 1.89 [0.18; 20.31]

Recurrent thromboembolic event 2.83 [0.30; 26.52]

Thrombus extension 0.47 [0.09; 2.49]

Short term haemorrhage 1.89 [0.36; 9.95]

Thrombus extension 0.36 [0.13; 0.95]

all cause death 0.50 [0.20; 1.27]

Recurrent thromboembolic event 0.50 [0.20; 1.27]

Short term haemorrhage 0.33 [0.04; 3.14]

all cause death 0.00 [0.00; NaN]

Recurrent thromboembolic event 0.00 [0.00; NaN]

Thrombus extension 0.84 [0.39; 1.83]

Short term haemorrhage 0.00 [0.00; NaN]

Nadroparin Subcutaneous twice daily for 10 Days, 90 U/kg BID (n=70)

vs.

unfractionated heparin intravenous APPTx1.5-2 (n=66)

Sample size: 70/66

Primary endpoint:

FU duration: 12 Weeks

Nadroparin Subcutaneous twice daily for >=0 Days, 90 U/kg BID (n=85)

vs.

unfractionated heparin intravenous APPTx1.5-2 (n=85)

Sample size: 85/85

Primary endpoint:

FU duration: 6 Months

Nadroparin Subcutaneous twice daily for 10 Days, 92 U/kg BID (n=74)

vs.

unfractionated heparin subcutaneous twice daily APPTx1.5-2.5 (n=75)

Sample size: 74/75

Primary endpoint:

FU duration: 3 Months

Mortality 0.73 [0.32; 1.69]

Haemorraghic events 0.62 [0.29; 1.34]

Recurrent thromboembolic events 0.57 [0.30; 1.11]

Once daily nadroparin 20,500 (AXa IU/ml)continued for at least 5 days (n=316)

vs.

twice daily nadroparin 10,250 (AXa IU/ml)continued for at least 5 days (n=335)

double blind

Parallel groups

Sample size: 316/335

Primary endpoint:

FU duration:

recurrent VTE 0.43 [0.19; 0.98]

all bleeding 3.76 [1.63; 8.68]

Major hemorrhage 1.83 [0.68; 4.94]

rivaroxaban (15 mg twice daily for 3 weeks, then 20 mg once daily for a total of 6 months) (n=203)

vs.

dalteparin (200 IU/kg daily during month 1, then 150 IU/kg daily for months 2-6) (n=203)

open-design

Sample size: 203/203

Primary endpoint:

FU duration:

pilot trial

All-cause mortality 1.05 [0.60; 1.85]

Major hemorrhage 1.00 [0.36; 2.75]

Recurrent DVT/DVTextension (total) 0.44 [0.19; 1.02]

Thrombocytopenia 1.50 [0.44; 5.15]

death at 3 months 1.05 [0.60; 1.85]

Tinzaparin 175 antiXa/kg SQ daily for 12 weeks (n=-9)

vs.

UFH for 5 days followed by vitamin K antagonist (target INR 2-3) for 12 weeks (n=-9)

outcome assessment blinded

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration: 3 months

VTE during follow-up after active anticoagulant treatment 1.00 [0.50; 2.01]

VTE during active anticoagulant treatment 0.76 [0.40; 1.43]

DVT (recurrent) 0.21 [0.05; 0.92]

bleeding 0.34 [0.04; 3.24]

VTE at the end of trial 0.47 [0.19; 1.20]

VTE during follow-up after active anticoagulant treatment 0.17 [0.02; 1.40]

VTE during active anticoagulant treatment 0.73 [0.24; 2.24]

PE 1.37 [0.31; 5.98]

LMWH, 175 IU/kg qd followed by Tinzaparin 175 IU/kg qd (n=369)

vs.

UFH 5 d, followed by UFH therapeutic APTT followed by Warfarin target INR 2-3 (n=368)

open

Sample size: 369/368

Primary endpoint:

FU duration: 9 mo

tinzaparin SC 175 IU anti-Xa per kg once daily for 6 months (n=119)

vs.

acenocoumarol for target INR 2-3 for 6 months after initial LMWH (until INR 2-3) (n=122)

open

Parallel groups

Sample size: 119/122

Primary endpoint: symptomatic recurrent venous thromboembolism

FU duration: 12 months

Short term haemorrhage 0.09 [0.01; 0.72]

all cause death 0.49 [0.24; 1.02]

Recurrent thromboembolic event 0.41 [0.16; 1.04]

Tinzaparin Subcutaneous once daily for >= Days, 175 U/kg BID (n=213)

vs.

unfractionated heparin intravenous APPTx2-3 (n=219)

Sample size: 213/219

Primary endpoint:

FU duration: 3 Months

Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.05 [0.01; 0.19]

Incidence of recurrent VTE 0.52 [0.37; 0.74]

Mortality 0.75 [0.41; 1.40]

Incidence of major bleeding 4.88 [0.57; 41.60]

Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.17 [0.02; 1.43]

Mortality 1.32 [0.61; 2.87]

Incidence of major bleeding 1.73 [0.64; 4.71]

Incidence of recurrent VTE 1.17 [0.68; 2.02]

Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.52 [0.05; 5.61]

Incidence of major bleeding (period after cessation of study medication until end of follow-up) NaN [NaN; NaN]

Mortality (period after cessation of study medication until end of follow-up) NaN [NaN; NaN]

Mortality ∞ [NaN; ∞]

Incidence of major bleeding NaN [NaN; NaN]

Incidence of recurrent VTE 0.62 [0.15; 2.52]

6 months treatment with warfarin or dicoumarol adjusted for a target INR between 2.0 - 2.85 (n=-9)

vs.

1.5 months warfarin or dicoumarol adjusted for a target INR between 2.0 - 2.85 (n=-9)

open

Parallel groups

Sample size: -9/-9

Primary endpoint: recurrent VTE, major bleeding, death

FU duration: Two years after randomization

Long course of therapy (6 months for proximal DVT and/or PE; 12 weeks for calf DVT) by fluindione adjusted for INR range of 2.0 to 3.0 (n=-9)

vs.

Short oral anticoagulant course (3 months for proximal DVT and/or PE; 6 weeks for isolated calf DVT) by fluindione adjusted for INR range of 2.0 to 3.0 (n=-9)

randomization at the end of heparin therapy

open

Parallel groups

Sample size: -9/-9

Primary endpoint: Recurrent VTE

FU duration: 15 months after randomizationÛ

continuation for 2 additionnal months of warfarin adjusted to achieve a target INR between 2.0 and 3.0. (n=-9)

vs.

discontinuation (after 1 months) (n=-9)

double blind

Parallel groups

Sample size: -9/-9

Primary endpoint: recurrent VTE

FU duration: 11 months (after randomizatio)

Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.11 [0.01; 0.83]

Incidence of major bleeding (period after cessation of study medication until end of follow-up) ∞ [NaN; ∞]

Mortality (period after cessation of study medication until end of follow-up) 0.96 [0.40; 2.33]

Mortality 0.96 [0.40; 2.33]

Incidence of major bleeding ∞ [NaN; ∞]

Incidence of recurrent VTE 0.56 [0.23; 1.37]

Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.06 [0.01; 0.45]

Incidence of recurrent VTE 0.06 [0.01; 0.45]

Incidence of major bleeding (period after cessation of study medication until end of follow-up) ∞ [NaN; ∞]

Mortality (period after cessation of study medication until end of follow-up) 0.35 [0.04; 3.30]

Mortality 0.35 [0.04; 3.30]

Incidence of major bleeding ∞ [NaN; ∞]

DVT 0.88 [0.47; 1.66]

Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.36 [0.12; 1.11]

Incidence of major bleeding (period after cessation of study medication until end of follow-up) 3.97 [0.45; 35.06]

Mortality 0.99 [0.36; 2.75]

Incidence of major bleeding 1.99 [0.37; 10.65]

PE (with or without DVT) 1.65 [0.40; 6.78]

Incidence of recurrent VTE 0.99 [0.57; 1.73]

Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.16 [0.02; 1.34]

Mortality 1.67 [0.68; 4.14]

Incidence of major bleeding 2.93 [0.31; 27.85]

Incidence of recurrent VTE 0.81 [0.42; 1.56]

Incidence of recurrent VTE 0.38 [0.21; 0.68]

Mortality 0.50 [0.15; 1.63]

Incidence of major bleeding 2.48 [0.49; 12.67]

Incidence of recurrent VTE (period after cessation of study medication until end of follow-up) 0.12 [0.04; 0.40]

Incidence of recurrent VTE 0.12 [0.04; 0.40]

Mortality 0.60 [0.28; 1.26]

Incidence of major bleeding 3.19 [0.90; 11.29]

continuation for 2 months of warfarin adjusted INR value of 2.0 to 3.0 (n=-9)

vs.

Discontinue oral anticoagulant therapy (after 1 months) (n=-9)

double blind

Parallel groups

Sample size: -9/-9

Primary endpoint: RecurrentDVT or PE andmajor bleeding

FU duration: 11 months after randomization.

Continuation of the oral anticoagulant therapy up to 24 months, warfarin was adjusted to achieve a target INR between 2.0 and 3.0. (n=-9)

vs.

discontinuation (after 3 months) (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

continuation for 9 additional months; warfarin or acenocoumarol adjusted to achieve a target INR between 2.0 and 3.0 (n=-9)

vs.

discontinuation (after 3 months months) (n=-9)

open

Parallel groups

Sample size: -9/-9

Primary endpoint: Recurrent VTE

FU duration: 33 months

continuation for 3 or 9 additionnal months of warfarin or other oral anticoagulant was adjusted to achieve a target INR between 2.0 and 3.0. (n=-9)

vs.

discontinuation (after 3 months) (n=-9)

open

Parallel groups

Sample size: -9/-9

Primary endpoint: Recurrence of symptomatic confirmed VTE./pj

FU duration: 33 months

extension with low-intensity warfarin (target INR, 1.5 to 2.0) (n=255)

vs.

placebo (n=253)

Parallel groups

Sample size: 255/253

Primary endpoint:

FU duration: 2.1 years

indefinite warfarin or dicoumarol adjusted for a target INR between 2.0 and 2.85 (n=-9)

vs.

6 months warfarin or dicoumarol adjusted for a target INR between 2.0 and 2.85 (n=-9)

open

Parallel groups

Sample size: -9/-9

Primary endpoint: recurrent VTE, death, major bleeding

FU duration: Four years after randomization

All-cause mortality 1.16 [0.58; 2.34]

Major hemorrhage 0.46 [0.04; 4.90]

Recurrent DVT/DVTextension (total) 2.29 [0.46; 11.31]

Thrombocytopenia 0.46 [0.04; 4.90]

Tinzaparin 175 IU/kg SQ daily (warfarin started simultaneously and continued for 90 days) (n=-9)

vs.

dalteparin 200 IU/kg daily for at least 5 days ((warfarin started simultaneously and continued for 90 days) (n=-9)

outcome assessment blinded

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration: 3 months

Recurrent DVT/DVT extension (symptomatic) 0.17 [0.09; 0.31]

VTA 0.24 [0.15; 0.40]

All-cause mortality 0.86 [0.29; 2.53]

Major hemorrhage 1.20 [0.37; 3.90]

any bleedings 1.21 [0.96; 1.51]

ximelagatran 24 mg twice daily for 18 months (n=612)

vs.

placebo for 18 months (n=611)

double blind

Parallel groups

Sample size: 612/611

Primary endpoint: symptomatic recurrent venous

FU duration: 18 months

extended treatment with Ximelagatran 24mg twice daily after initial anticoagulant treatment for 6 months (n=-9)

vs.

placebo (initial anticoagulant treatment for 6 months) (n=-9)

single blind and outcome ass.

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration: 18 months

oral ximelagatran (24, 36, 48 or 60 mg twice daily) for 2 weeks (n=-9)

vs.

dalteparin and warfarin for 2 weeks (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

ximelagatran 36 mg twice daily (n=-9)

vs.

subcutaneous enoxaparin, 1 mg/kg twice daily, for 5 to 20 days followed by warfarin adjusted to maintain an international normalized ratio of 2.0 to 3.0. (n=-9)

double blind

Sample size: -9/-9

Primary endpoint: 28 countries

FU duration:

pulmonary embolims (symptomatic and asymptomatic) 0.22 [0.05; 0.93]

death 1.00 [0.29; 3.40]

major bleeding 1.50 [0.54; 4.14]

asymptomatic pulmonary embolism 0.00 [0.00; NaN]

symptomatic pulmonary embolism 0.40 [0.08; 2.04]

caval filter (n=200)

vs.

no filter (n=200)

2x2 factorial design also comparing LMWH vs unfractionated heparin

open

Parallel groups

Sample size: 200/200

Primary endpoint: none

FU duration: 12 days and 2 years

recurrent VTE 0.33 [0.22; 0.49]

Major bleeding 0.49 [0.09; 2.69]

major or clinically relevant nonmajor bleeding 1.21 [0.70; 2.11]

recurrent VTE 0.36 [0.25; 0.53]

Major bleeding 0.25 [0.03; 2.28]

major or clinically relevant nonmajor bleeding 1.62 [0.96; 2.74]

Extended Treatment with apixaban 2.5 mg twice daily 12 months (n=842)

vs.

placebo (n=829)

3 arms: apixaban 2.5mg, 5mg twice daily, placebo

double blind

Parallel groups

Sample size: 842/829

Primary endpoint:

FU duration: 12 mo

Extended Treatment with apixaban 5 mg twice daily 12 months (n=815)

vs.

placebo (n=829)

3 arms: apixaban 2.5mg, 5mg twice daily, placebo

double blind

Sample size: 815/829

Primary endpoint:

FU duration: 12 mo

Major bleeding 0.31 [0.17; 0.55]

recurrent DVT only 0.61 [0.35; 1.06]

death 0.79 [0.53; 1.19]

All deaths 0.79 [0.53; 1.19]

non fatal PE 1.19 [0.68; 2.06]

fatal PE 0.50 [0.05; 5.57]

Symptomatic nonfatal pulmonary embolism 1.19 [0.68; 2.06]

recurrent VTE during treatment 0.84 [0.60; 1.18]

Symptomatic deep-vein thrombosis 0.61 [0.35; 1.06]

Death related to venous thromboembolism 0.85 [0.38; 1.90]

recurrent VTE 0.84 [0.60; 1.18]

apixaban 5 mg twice-daily, 10 mg twice-daily, or 20 mg once-daily for 84-91 days (n=358)

vs.

low molecular weight heparin followed by vitamin K antagonists (n=118)

open

Parallel groups

Sample size: 358/118

Primary endpoint: recurrent VTE or asymptomatic deterioration in the

FU duration:

dose-ranging study; the primary efficacy endpoint was the composite of symptomatic recurrent venous thromboembolism and asymptomatic deterioration of bilateral compression ultrasound or perfusion lung scan

apixaban 10 mg twice daily for 7 days then 5 mg, twice daily, 6 months (n=2691)

vs.

conventional therapy: enoxaparin 1mg/kg twice daily until INR>=2 then warfarin for an INR between 2-4, once daikly, 6 months (n=2704)

double blind

Parallel groups

Sample size: 2691/2704

Primary endpoint: Venous thromboembolic recurrence or death

FU duration: 6 mo

any bleeding 0.74 [0.65; 0.85]

major or clinically relevant nonmajor bleeding 0.55 [0.42; 0.72]

All deaths 0.89 [0.47; 1.71]

Major bleeding 0.52 [0.27; 1.01]

Symptomatic nonfatal pulmonary embolism 1.99 [0.68; 5.82]

recurrent VTE during treatment 1.44 [0.79; 2.62]

Death related to venous thromboembolism 1.00 [0.06; 15.93]

recurrent VTE 1.44 [0.79; 2.62]

dabigatran 150 mg twice daily for an additional period of 6 to 36 months (n=1430)

vs.

warfarin (to maintain an international normalized ratio of 2.0 to 3.0) for an additional period of 6 to 36 months (n=1426)

dabigatran 150 mg twice daily or with warfarin (to maintain an international normalized ratio of 2.0 to 3.0) for an additional period of 6 to 36 months after 3 to 12 months of anticoagulant therapy

double-blind

Parallel groups

Sample size: 1430/1426

Primary endpoint: recurrent symptomatic VTE and related deaths

FU duration: 6 to 36 months

recurrent VTE during treatment 0.08 [0.02; 0.25]

recurrent VTE 0.08 [0.02; 0.25]

All deaths 0.00 [0.00; NaN]

Major bleeding ∞ [NaN; ∞]

dabigatran 150 mg twice daily for an additional period of 6 months (n=681)

vs.

placebo (n=662)

patients randomized after 6-18 months of anticoagulant therapy

double-blind

Parallel groups

Sample size: 681/662

Primary endpoint: recurrent symptomatic VTE and related deaths

FU duration:

any bleeding 0.73 [0.62; 0.86]

All deaths 0.99 [0.55; 1.81]

Major bleeding 0.83 [0.46; 1.49]

Symptomatic nonfatal pulmonary embolism 1.84 [0.74; 4.61]

recurrent VTE during treatment 1.10 [0.66; 1.84]

Symptomatic deep-vein thrombosis 0.88 [0.45; 1.72]

Death related to venous thromboembolism 0.33 [0.03; 3.18]

recurrent VTE 1.05 [0.66; 1.70]

any bleeding 0.71 [0.60; 0.84]

death 1.01 [0.59; 1.76]

Major bleeding 0.69 [0.36; 1.33]

recurrent VTE during treatment 1.09 [0.65; 1.81]

recurrent VTE 1.09 [0.65; 1.81]

dabigatran 150 mg twice daily in a fixed-dose (n=1274)

vs.

warfarin dose-adjusted to an INR between 2.0 and 3.0 (n=1265)

double blind

Parallel groups

Sample size: 1274/1265

Primary endpoint: recurrent VTE or VTE-related death

FU duration: 6 months

dabigatran, 150 mg twice daily, for 6 months (n=1294)

vs.

warfarin, dose-adjusted to an INR of 2.0 and 3.0, for 6 months (n=1295)

double-blind

Parallel groups

Sample size: 1294/1295

Primary endpoint: symptomatic recurrence + related death

FU duration: 6 months

any bleeding 0.85 [0.79; 0.92]

major or clinically relevant nonmajor bleeding 0.83 [0.72; 0.95]

recurrent DVT only 0.89 [0.71; 1.12]

Major bleeding 0.85 [0.60; 1.21]

non fatal PE 0.83 [0.57; 1.21]

fatal PE 1.34 [0.30; 5.96]

recurrent VTE during treatment 0.83 [0.60; 1.14]

heparin then edoxaban 60mg daily (30mg if creatine clearnce of 30 to 50 ml/min or <60kg) for 3 to 12 months (n=4143)

vs.

heparin then warfarin (n=4149)

double-blind

Parallel groups

Sample size: 4143/4149

Primary endpoint: recurrent symptomatic venous thromboembolism

FU duration:

recurrent DVT only 0.71 [0.34; 1.48]

All deaths 1.19 [0.82; 1.73]

Major bleeding 0.85 [0.48; 1.48]

non fatal PE 0.59 [0.31; 1.13]

fatal PE 1.07 [0.53; 2.16]

recurrent VTE 0.75 [0.51; 1.12]

fondaparinux subcutaneously once daily (n=1103)

vs.

continuous intravenous infusion of unfractionated heparin (n=1110)

open

Parallel groups

Sample size: 1103/1110

Primary endpoint: symptomatic recurrent/new VTE

FU duration: 3 mo

any bleeding 0.64 [0.48; 0.87]

recurrent DVT only 0.94 [0.49; 1.83]

All deaths 1.03 [0.64; 1.67]

Major bleeding 0.71 [0.34; 1.47]

non fatal PE 0.95 [0.53; 1.73]

fatal PE 1.00 [0.25; 3.99]

recurrent VTE during treatment 0.98 [0.64; 1.48]

recurrent VTE 0.98 [0.64; 1.48]

All deaths 1.79 [1.17; 2.74]

non fatal PE 5.11 [1.48; 17.62]

recurrent VTE 2.10 [1.20; 3.67]

recurrent DVT only 1.02 [0.43; 2.45]

Major bleeding 0.51 [0.26; 1.02]

fatal PE 2.45 [0.87; 6.94]

subcutaneous idraparinux (2.5 mg once weekly) (n=1452)

vs.

heparin followed by an adjusted-dose vitamin K antagonist (n=1452)

open

Parallel groups

Sample size: 1452/1452

Primary endpoint: 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal)

FU duration: 3 mo (6 mo)

subcutaneous idraparinux (2.5 mg once weekly) (n=1095)

vs.

heparin followed by an adjusted-dose vitamin K antagonist (n=1120)

open

Parallel groups

Sample size: 1095/1120

Primary endpoint: 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal)

FU duration: 3 mo (6 mo)

recurrent DVT only 0.16 [0.06; 0.41]

non fatal PE 0.15 [0.03; 0.67]

recurrent VTE 0.19 [0.09; 0.40]

major or clinically relevant nonmajor bleeding 5.07 [2.28; 11.31]

death 0.49 [0.04; 5.43]

All deaths 0.49 [0.04; 5.43]

Major bleeding ∞ [NaN; ∞]

fatal PE 0.00 [0.00; NaN]

Death related to venous thromboembolism 0.99 [0.06; 15.74]

rivaroxaban 20 mg once-daily for an additional 6 or 12 months (n=602)

vs.

placebo (n=595)

double blind

Parallel groups

Sample size: 602/595

Primary endpoint: symptomatic recurrent VTE

FU duration:

recurrent DVT only 0.50 [0.26; 0.94]

All deaths 0.77 [0.51; 1.17]

Major bleeding 0.70 [0.35; 1.38]

non fatal PE 1.10 [0.59; 2.08]

fatal PE ∞ [NaN; ∞]

Symptomatic nonfatal pulmonary embolism 1.10 [0.59; 2.08]

recurrent VTE during treatment 0.70 [0.46; 1.07]

Death related to venous thromboembolism 0.66 [0.19; 2.35]

recurrent VTE 0.70 [0.46; 1.07]

rivaroxaban 20, 30, or 40 mg once daily (n=-9)

vs.

low-molecular-weight heparin followed by vitamin K antagonists (n=-9)

open

Sample size: -9/-9

Primary endpoint:

FU duration:

rivaroxaban 15 mg twice daily for 3 weeks, then 20 mg daily (n=1731)

vs.

enoxaparin 1 mg/kg twice daily >=5 days, then warfarin with target INR between 2-3 (n=1718)

treatment duration (3, 6, or 12 months) decided by physicians. treatment duration of 6 months in 63%, 3 mo in 12% and 12 mo in 25%

open (assessor-blind)

Parallel groups

Sample size: 1731/1718

Primary endpoint: Symptomatic recurrent VTE

FU duration:

rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) for 3, 6, or 12 months (n=2419)

vs.

standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist (n=2413)

open

Parallel groups

Sample size: 2419/2413

Primary endpoint: symptomatic recurrent venous thromboembolism

FU duration: 9.8 months

death 0.25 [0.08; 0.79]

non fatal PE 0.10 [0.01; 0.73]

recurrent VTE 0.27 [0.11; 0.67]

major or clinically relevant nonmajor bleeding 3.11 [1.48; 6.56]

recurrent DVT only 0.29 [0.08; 1.02]

Major bleeding ∞ [NaN; ∞]

fatal PE 2.09 [0.19; 23.00]

once-weekly injections of 2.5 mg of idraparinux for 6 months (n=594)

vs.

placebo (n=621)

Parallel groups

Sample size: 594/621

Primary endpoint:

FU duration: 6 months

Bleeding (early) ∞ [NaN; ∞]

Complete clot lysis (late) 1.25 [0.61; 2.56]

Post-thrombotic syndrome (late) 0.82 [0.56; 1.21]

Leg ulceration (late) 2.00 [0.20; 20.49]

Stroke/intracerebral bleeding (eraly) NaN [NaN; NaN]

tPA 20 mg IV into pedal vein over 4 hours each day for 7 days. Heparin IV given concomitantly, with adjustment (n=-9)

vs.

heparin IV, adjusted for 7 days (n=-9)

single blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

Any improvement in venous patency (early) 3.00 [1.33; 6.75]

Mortality (early) 0.00 [0.00; NaN]

Pulmonary embolism (early) 1.00 [0.07; 14.96]

Bleeding (early) 1.00 [0.29; 3.48]

Complete clot lysis (late) ∞ [NaN; ∞]

Post-thrombotic syndrome (late) 0.47 [0.18; 1.25]

Mortality (late) 1.33 [0.34; 5.24]

Leg ulceration (late) 0.00 [0.00; NaN]

Stroke/intracerebral bleeding (eraly) NaN [NaN; NaN]

Complete clot lysis (early) 6.78 [0.88; 52.23]

Mortality (early) ∞ [NaN; ∞]

Bleeding (early) 1.58 [0.58; 4.31]

Any improvement in venous patency (early) 1.35 [0.92; 1.98]

Complete clot lysis (late) 4.80 [0.67; 34.64]

Stroke/intracerebral bleeding (eraly) ∞ [NaN; ∞]

Normal venous function (late) 6.14 [1.62; 23.28]

Complete clot lysis (late) 6.14 [1.62; 23.28]

Complete clot lysis (early) ∞ [NaN; ∞]

Mortality (early) NaN [NaN; NaN]

Pulmonary embolism (early) 0.00 [0.00; NaN]

Bleeding (early) NaN [NaN; NaN]

Any improvement in venous patency (early) ∞ [NaN; ∞]

Stroke/intracerebral bleeding (eraly) NaN [NaN; NaN]

Complete clot lysis (early) 1.24 [0.59; 2.60]

Mortality (early) 1.12 [0.08; 16.52]

Pulmonary embolism (early) NaN [NaN; NaN]

Bleeding (early) 3.35 [0.38; 29.27]

Normal venous function (late) 1.04 [0.59; 1.83]

Complete clot lysis (late) 1.47 [0.77; 2.79]

Leg ulceration (late) NaN [NaN; NaN]

Stroke/intracerebral bleeding (eraly) NaN [NaN; NaN]

Stroke/intracerebral bleeding (eraly) NaN [NaN; NaN]

Complete clot lysis (early) 3.00 [0.81; 11.08]

Mortality (early) 1.00 [0.17; 5.77]

Pulmonary embolism (early) 0.00 [0.00; NaN]

Bleeding (early) 1.80 [0.43; 7.59]

Any improvement in venous patency (early) 1.75 [0.78; 3.93]

Stroke/intracerebral bleeding (eraly) NaN [NaN; NaN]

streptokinase 250,000 U loading IV, then 100,000 IU/hour IV 72-96 hours (n=43)

vs.

heparin 15,000 IU IV bolus, 30,000 IU infusion IV 72-90 hours¢ßl (n=0)

single blind

Parallel groups

Sample size: 43/0

Primary endpoint:

FU duration:

hydrocortisone 100 mg IV then streptokinase IV 250,000 U over 30 minutes, then 100,000 U/hour titrated for 72 hours. Followed by IV heparin titrated over 7 days (n=50)

vs.

IV heparin 150 U/kg loading dose then titrated for 10 days (n=0)

single blind

Parallel groups

Sample size: 50/0

Primary endpoint:

FU duration:

catheter-directed thrombolysis with streptokinase using popliteal approach. (n=35)

vs.

heparin IV bolus 5000 U, then adjusted continuous infusion. Warfarin begun the same evening (n=0)

single blind

Parallel groups

Sample size: 35/0

Primary endpoint:

FU duration:

streptokinase 50,000 IU IV over 15 minutes then 100,000 IU over 12 hours for up to 7 days, titrated. Given with 5000 IU heparin IV over 12 hours. Warfarin begun after streptokinase ended (n=38)

vs.

heparin 5000 IUIVbolus then 30,000 IUper day, titrated for 7 days.Warfarin begun simultaneously (n=0)

single blind

Parallel groups

Sample size: 38/0

Primary endpoint:

FU duration:

titrated dose of streptokinase IV into ankle veinmage/pj (n=34)

vs.

heparin IV into affected limbitm (n=0)

open

Parallel groups

Sample size: 34/0

Primary endpoint:

FU duration:

streptokinase 500,000 U IV over 30 minutes, 900,000 U every 6 hours for 5 days (n=-9)

vs.

heparin 10,000 U over 5 minutes, then 10,000 to 15,000 U every 6 hours for 5 dayslicatio (n=-9)

single blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

Systemic streptokinase 3,000,000 U/day over 6 hours in conjunction with heparin for up to 7 days. Premedication: hydrocortisone 100 mg, ranitidine 50 mg, clemastine 2 mg (n=-9)

vs.

heparin IV, adjusted (n=-9)

single blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

Bleeding (early) ∞ [NaN; ∞]

Any improvement in venous patency (early) 3.28 [0.90; 11.91]

Any improvement in venous patency (early) 2.57 [1.35; 4.88]

Bleeding (early) 2.56 [0.53; 12.46]

Stroke/intracerebral bleeding (eraly) NaN [NaN; NaN]

tPA alone 0.05 mg/kg/hour IV over 24 hours, then heparin100U/kg bolus, then 1000 U/hour, adjusted (n=-9)

vs.

heparin alone 100 U/kg bolus, then 1000 U/hour (n=-9)

single blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

local tPA 20 mg/day, over 4 hours via pedal vein for 4-7 days. IV heparin given simultaneously at 1000 IU/hour, adjusted (n=-9)

vs.

heparin IV, adjusted (n=-9)

single blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

tPA + IV heparin (n=83)

vs.

5000 U bolus then 30,000 U/24 hours, adjusted for 7-10 days (+placebo) (n=0)

double blind

Parallel groups

Sample size: 83/0

Primary endpoint:

FU duration:

IV tPA 100 mg on day 1, 50 mg tPA on day 2. 10% of dose given as bolus; heparin 5000 U IV bolus then continuous infusion of 1000 U per hour for up to 72 hours (n=-9)

vs.

heparin 5000 U IV bolus then continuous infusion of 1000 U per hour for up to 72 hours (+placebo) (n=-9)

double blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

tPA 0.05 mg/kg/hour IV over 24 hours and heparin 100U/kg bolus, then 1000 U/hour, adjusted (n=-9)

vs.

heparin alone 100 U/kg bolus, then 1000 U/hour. (n=-9)

single blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

IV tPA 50 mg on day 1, repeated on day 2. 10% of dose given as bolus; heparin 5000 U IV bolus then continuous infusion of 1000 U per hour for up to 72 hours (n=-9)

vs.

heparin 5000 U IV bolus then continuous infusion of 1000 U per hour for up to 72 hours (+placebo) (n=-9)

double blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

Mortality (early) 0.00 [0.00; NaN]

Bleeding (early) 0.61 [0.18; 2.06]

Any improvement in venous patency (early) 0.73 [0.05; 9.97]

Stroke/intracerebral bleeding (eraly) NaN [NaN; NaN]

Complete clot lysis (late) 2.13 [1.17; 3.86]

Mortality (early) ∞ [NaN; ∞]

Post-thrombotic syndrome (late) 0.65 [0.40; 1.04]

Leg ulceration (late) 1.00 [0.07; 15.00]

Stroke/intracerebral bleeding (eraly) NaN [NaN; NaN]

urokinase 200,000 U IV over 24 hours. After 18 hours, heparin loading dose of 15,000 units then 40,000 U/day for 5 days (+placebo) (n=20)

vs.

heparin 40,000 U/day IV for 6 days (+placebo) (n=0)

Double blind

Parallel groups

Sample size: 20/0

Primary endpoint:

FU duration:

Urokinase 100,000 IU/hr IV into pedal vein continuously for 7 days. Heparin IV for 7 days. Plasminogen monitored. Warfarin from day 7 to 12 monthsd=132 (n=-9)

vs.

heparin IV, adjusted for 7 days (n=-9)

single blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

Local urokinase 100,000 IU/day infused continuously. Fibrinogen and plasminogen monitored. Heparin IV given concomitantly (n=-9)

vs.

heparin IV, adjusted (n=-9)

single blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration:

Systemic urokinase 5,000,000 IU/day over 4 hours for up to 7 days. IV heparin given concomitantly (n=-9)

vs.

heparin IV, adjusted (n=-9)

single blind

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration: