Nadroparin LMWH

Description Results

recurrent angina at 14 days 0.93 [0.76; 1.14]

long term MI or death 1.10 [0.83; 1.44]

death 1.06 [0.51; 2.18]

all revascularisations 0.95 [0.67; 1.36]

myocardial infarction 1.09 [0.66; 1.79]

recurrent angina 0.84 [0.67; 1.06]

death, myocardial infarction, or recurrent at 14 days 0.99 [0.83; 1.18]

myocardial infarction or death 0.99 [0.63; 1.56]

death at 30 days 1.18 [0.79; 1.77]

myocardial infarction at 30 days 1.10 [0.79; 1.52]

recurrent angina at 14 days 1.11 [0.92; 1.35]

long term MI or death 1.15 [0.87; 1.50]

death 1.26 [0.70; 2.29]

all revascularisations 0.95 [0.78; 1.14]

myocardial infarction 0.98 [0.64; 1.49]

recurrent angina 1.11 [0.92; 1.35]

myocardial infarction or death 1.08 [0.74; 1.56]

nadroparin for 6 days (+aspirin) (n=1166)

vs.

unfractionated heparin for 6 days (+aspirin) (n=1151)

Double blind

Parallel groups

Sample size: 1166/1151

Primary endpoint: death, MI, recurent or refractory angina

FU duration: 14 days

nadroparin for 14 days (n=1151)

vs.

unfractionated heparin for 14 days (n=1151)

double blind

Sample size: 1151/1151

Primary endpoint: death, MI, recurent or refractory angina

FU duration: 14 days

Symptomatic venous thromboembolism at the end of treatment 0.77 [0.05; 12.00]

Symptomatic venous thromboembolism at the end of treatment 0.34 [0.04; 3.15]

Symptomatic venous thromboembolism at the end of treatment NaN [NaN; NaN]

Nadroparin, 4750–6650 antifactor Xa IU twice daily, 10 days (n=61)

vs.

Unfractioned heparin: no bolus, infusion, 20 IU/kg per hour (n=47)

open (blind assessment)

Parallel groups

Sample size: 61/47

Primary endpoint: Arnesen and Marder phlebographic scores

FU duration: 3 mo

Nadroparin, 4750–6650 antifactor Xa IU twice daily, 10 days (n=45)

vs.

Unfractioned heparin: bolus 100 IU/kg, infusion 35 000 IU/d (n=46)

sub group of a trial initially including patients with acute symptomatic VTE

open

Parallel groups

Sample size: 45/46

Primary endpoint:

FU duration: 6 mo

Nadroparin, 76 IU/kg twice daily, 14 days (n=35)

vs.

Unfractioned heparin: bolus 50 IU/kg, infusion 600 IU/kg per day (n=33)

open

Parallel groups

Sample size: 35/33

Primary endpoint: pulmonary vascular obstruction

FU duration: 14 d

dose-finding study

nadroparin (s.c. 0.6 ml for 6150 IU anti-Xa once daily)j (n=-9)

vs.

Naproxene (oral 500 mg once daily) (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

LMWH (nadroparin) body-weight adjusted (full dose for 10 days followed by half dose for 20 additional days)àĆ (n=-9)

vs.

nadroparin (2850 anti-Xa IU) for 30 days (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

nadroparin (s.c. 0.6 ml for 6150 IU anti-Xa once daily)j (n=-9)

vs.

Naproxene (oral 500 mg once daily) (n=-9)

Sample size: -9/-9

Primary endpoint:

FU duration:

asymptomatic proximal DVT 0.33 [0.04; 3.10]

asymptomatic proximal DVT 0.11 [0.03; 0.47]

All-cause death during follow-up 1.05 [0.41; 2.69]

Major bleeding during follow-up 2.09 [0.54; 8.16]

Symptomatic pulmonary embolism during follow-up NaN [NaN; NaN]

DVT 0.55 [0.30; 1.00]

Asymptomatic deep vein thrombosis during follow-up. 0.57 [0.30; 1.06]

Symptomatic deep vein thrombosis during follow-up NaN [NaN; NaN]

All-cause death during follow-up 0.98 [0.78; 1.24]

Major bleeding during follow-up 0.34 [0.04; 3.24]

Symptomatic pulmonary embolism during follow-up 0.59 [0.27; 1.29]

fatal PE 0.59 [0.27; 1.29]

PE 0.59 [0.27; 1.29]

total bleeding 0.58 [0.17; 1.91]

total bleeding 0.00 [0.00; NaN]

wound hematoma 0.00 [0.00; NaN]

transfusin 1.15 [0.65; 2.04]

asymptomatic DVT 0.36 [0.13; 0.99]

death 0.83 [0.26; 2.69]

clinical PE 0.00 [0.00; NaN]

wound hematoma 0.79 [0.23; 2.65]

symptomatic thromboembolism 0.00 [0.00; NaN]

transfusion 1.14 [0.85; 1.53]

symptomatic thromboembolism 0.27 [0.07; 0.95]

death 0.89 [0.40; 2.01]

total haemorrhage 0.99 [0.82; 1.19]

clinical PE 0.20 [0.02; 2.07]

asymptomatic DVT 0.63 [0.39; 1.01]

wound hematoma 0.97 [0.37; 2.55]

transfusion 1.01 [0.82; 1.25]

clinical PE NaN [NaN; NaN]

asymptomatic DVT NaN [NaN; NaN]

wound hematoma 0.00 [0.00; NaN]

Death NaN [NaN; NaN]

Major bleeding NaN [NaN; NaN]

Minor bleeding ∞ [NaN; ∞]

Pulmonary embolism NaN [NaN; NaN]

Symptomatic venous thromboembolism 0.41 [0.04; 3.88]

symptomatic deep vein thrombosis 0.30 [0.03; 2.88]

thromboembolic events (symptomatic or asymptomatic) 0.71 [0.48; 1.06]

proxymal DVT 0.60 [0.30; 1.18]

asymptomatic proximal DVT, symptomatic VTE, all death 0.29 [0.12; 0.71]

major or clinically relevant bleeding 3.01 [0.61; 14.88]

asymptomatic proximal DVT, symptomatic VTE, all death 0.28 [0.10; 0.82]

major or clinically relevant bleeding 1.49 [0.21; 10.51]

VTE (symptomatic or asymptomatic) 0.29 [0.12; 0.69]

PE NaN [NaN; NaN]

All-cause death during follow-up 0.98 [0.78; 1.24]

nadroparin 41/kgx1 days 1-3, 62/kg x1 days 4-11+elastic stockings (n=50)

vs.

no treatment (n=50)

open

Sample size: 50/50

Primary endpoint:

FU duration: 10 days

nadroparin 3075x1 preop, 6150x1 post op (n=72)

vs.

Placebo (n=78)

double blind

Sample size: 72/78

Primary endpoint:

FU duration: 10-12 days

Nadroparin 3800–5700E once daily, Until no longer mechanical ventilation, <=21 days (n=109)

vs.

placebo (n=114)

double blind

Parallel groups

Sample size: 109/114

Primary endpoint:

FU duration: <=21 days

nadroparin 7500E once daily, Until hospital discharge, <=21 days (n=1230)

vs.

placebo (n=1244)

double blind

Parallel groups

Sample size: 1230/1244

Primary endpoint:

FU duration: <=21 days

Nadroparin 2850 anti-Xa units (n=94)

vs.

Placebo (n=95)

Blind

Sample size: 94/95

Primary endpoint:

FU duration:

Nadroparin 2850 anti-Xa units (n=31)

vs.

No treatment (n=33)

Open

Sample size: 31/33

Primary endpoint:

FU duration:

Nadroparin 2850 (n=200)

vs.

UFH 10 000 units (n=200)

Blind

Sample size: 200/200

Primary endpoint:

FU duration: 10 days

Nadroparin 2850 (n=968)

vs.

UFH 15 000 units (n=941)

Open

Sample size: 968/941

Primary endpoint:

FU duration: 1 month

Nadroparin 2850 (n=46)

vs.

UFH 15 000 units (n=41)

Open

Sample size: 46/41

Primary endpoint:

FU duration:

Nadroparin 2850 anti Xa units (n=171)

vs.

UFH 10 000 units (n=173)

Open

Sample size: 171/173

Primary endpoint:

FU duration:

Nadroparin 2850 anti Xa units (n=241)

vs.

UFH 15 000 units (n=239)

Open

Sample size: 241/239

Primary endpoint:

FU duration:

in hospital thromboprophylaxis followed by out of hospital Nadroparin weight-adjusted for a total duration of 37-38 days (n=173)

vs.

Nadroparin weight-adjusted for 16-17 days (n=173)

Sample size: 173/173

Primary endpoint:

FU duration:

Nadroparin, 7500 Institute Choay anti-Xa units per day subcutaneously 18-24 hours postoperatively plus compression for 10 days (n=241)

vs.

compression stockings + placebo (n=244)

Sample size: 241/244

Primary endpoint:

FU duration: 56 days

once-daily subcutaneous injection of LMWH (nadroparin, 3800 anti-Xa IU) for 7 days (n=657)

vs.

full-length graduated compression stocking for 7 days (n=660)

3 arms: elastic stockings for 7 days; nadroparin 0.4 ml sc once daily for 7 days; nadroparin 0.4 ml sc once daily for 14 days

open (blinded assessment)

Parallel groups

Sample size: 657/660

Primary endpoint: prox DVT, VTE, death

FU duration: 3 months

once-daily subcutaneous injection of LMWH (nadroparin, 3800 anti-Xa IU) for 14 days (n=444)

vs.

full-length graduated compression stocking for 7 days (n=660)

3 arms: elastic stockings for 7 days; nadroparin 0.4 ml sc once daily for 7 days; nadroparin 0.4 ml sc once daily for 14 days

open (blinded assessment)

Parallel groups

Sample size: 444/660

Primary endpoint: prox DVT, VTE, death

FU duration: 3 months

Nadroparin 2850 IU (n=126)

vs.

no prophylaxis (n=126)

open

Parallel groups

Sample size: 126/126

Primary endpoint:

FU duration: 16 days

nadroparin 7500 u anti-Xa once daily (n=-9)

vs.

placebo (n=-9)

Parallel groups

Sample size: -9/-9

Primary endpoint:

FU duration: up to 21

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]

Mortality 0.73 [0.32; 1.69]

Haemorraghic events 0.62 [0.29; 1.34]

Recurrent thromboembolic events 0.57 [0.30; 1.11]

All-cause mortality 1.24 [0.52; 2.94]

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]

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

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:

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

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