pathology | Demonstrated benefit and harm | k | | | |
---|
acute coronary syndrome | versus placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CURE (PCI sub study), 2001 | clopidogrel vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
CURE (PCI sub study), 2001 | pretreatment with clopidogrel -+aspirin 75–325 mg) (n=1313) vs. placebo (+ aspirin 75–325 mg) (n=1345) | patients with non-ST-elevation acute coronary syndrome undergoing PCI | double blind Parallel groups Sample size: 1313/1345 Primary endpoint: ardiovascular death, MI, or urgent TVR FU duration: |
|
acute coronary syndrome | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
COMMIT, 2005 | clopidogrel vs placebo | non fatal MI 0.82 [0.70; 0.96] vascular events 0.92 [0.87; 0.97] | | non fatla stroke 0.89 [0.70; 1.13] | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
COMMIT, 2005 | clopidogrel 75 mg daily (n=22961) vs. placebo (n=22891) | patients admitted to hospital within 24 h of suspected acute MI onset | double-blind Parallel groups Sample size: 22961/22891 Primary endpoint: death, reinfarction, or stroke FU duration: until discharge or up to 4 wee | CLARITY-TIMI 28, 2005 | clopidogrel (300-mg loading dose, followed by 75 mg once daily)
(n=-9) vs. placebo
(n=-9)
| patients, 18 to 75 years of age, within 12 hours after the onset of an ST-elevation myocardial infarction
| double blind Sample size: -9/-9 Primary endpoint: death, reMI, occlusion FU duration: 30 days
|
|
acute coronary syndrome | versus aspirin No demonstrated result for efficacy clopidogrel + aspirin inferior to aspirin in terms of Major bleeds in CURE, 2001 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CURE, 2001 | clopidogrel + aspirin vs aspirin | Vasc events 0.82 [0.73; 0.90] fatal and non fatal MI 0.78 [0.68; 0.90] cardiovascular events 0.82 [0.73; 0.90] | Major bleeds 1.38 [1.13; 1.67] | Vasc deaths 0.93 [0.80; 1.08] Non vasc deaths 0.92 [0.60; 1.40] fatala and non fatal stroke 0.87 [0.64; 1.18] refractory ischemia 0.93 [0.83; 1.04] fatal bleeding 0.74 [0.34; 1.61] |
Trial | Treatments | Patients | Method |
---|
CURE, 2001 | clopidogrel 300 mg immediately, followed by 75 mg once daily + aspirin for 3 to 12 months (n=6259) vs. aspirin (+placebo) (n=6303) | acute coronary syndromes without ST-segment elevation within 24 hours after the onset of symptoms | double blind Parallel groups Sample size: 6259/6303 Primary endpoint: CV death, MI, stroke FU duration: NA (median <9 months) |
|
acute coronary syndrome | versus clopidogrel No demonstrated result for efficacy clopidogrel high-dose regimen inferior to clopidogrel standard-dose in terms of Major bleeds in CURRENT OASIS 7 (clopidogrel), 2010 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CURRENT OASIS 7 (clopidogrel), 2010 | clopidogrel high-dose regimen vs clopidogrel standard-dose | | Major bleeds 1.24 [1.05; 1.46] | vascular death, MI, stroke 0.94 [0.83; 1.06] Severe recurrent ischemia 0.93 [0.64; 1.36] Hemorrhagic stoke 0.67 [0.19; 2.37] Vasc events 0.94 [0.84; 1.06] all cause death 0.96 [0.82; 1.13] Vasc deaths 0.95 [0.81; 1.13] fatala and non fatal stroke 0.99 [0.70; 1.39] fatal and non fatal MI 0.86 [0.72; 1.02] cardiovascular events 0.94 [0.84; 1.06] fatal bleeding 1.07 [0.53; 2.16] |
Trial | Treatments | Patients | Method |
---|
CURRENT OASIS 7 (clopidogrel), 2010 | Double-dose clopidogrel (n=12520) vs. Standard-dose clopidogrel (n=12566) patients were also assigned in an open-label manner to 300 to 325 mg of aspirin once daily or 75- to 100-mg aspirin once daily | ACS patients referred for an invasive strategy (scheduled for percutaneous coronary intervention no more than 72 hours after randomization) about two thirds eventually underwent PCI (although PCI was planned for everyone who was randomized, about a third of the patients did not undergo the procedure because they were not considered suitable based on angiography findings) | open Factorial plan Sample size: 12520/12566 Primary endpoint: CV death/MI/stroke FU duration: 30 days |
|
acute myocardial infarction | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
COMMIT, 2005 | clopidogrel vs placebo | non fatal MI 0.82 [0.70; 0.96] vascular events 0.92 [0.87; 0.97] | | non fatla stroke 0.89 [0.70; 1.13] | | T1 vs T0 | | | |
Trial | Treatments | Patients | Method |
---|
COMMIT, 2005 | clopidogrel 75 mg daily (n=22961) vs. placebo (n=22891) | patients admitted to hospital within 24 h of suspected acute MI onset | double-blind Parallel groups Sample size: 22961/22891 Primary endpoint: death, reinfarction, or stroke FU duration: until discharge or up to 4 wee | CLARITY-TIMI 28, 2005 | clopidogrel (300-mg loading dose, followed by 75 mg once daily)
(n=-9) vs. placebo
(n=-9)
| patients, 18 to 75 years of age, within 12 hours after the onset of an ST-elevation myocardial infarction
| double blind Sample size: -9/-9 Primary endpoint: death, reMI, occlusion FU duration: 30 days
|
|
atrial fibrillation | versus anticoagulant No demonstrated result for efficacy aspirin + clopidogrel inferior to anticoagulant in terms of non fatal TE events,bleedings and vascular death* in ACTIVE W, 2006 aspirin + clopidogrel inferior to anticoagulant in terms of thrombo-embolic event (cerebral or systemic) in ACTIVE W, 2006 aspirin + clopidogrel inferior to anticoagulant in terms of ischemic stroke in ACTIVE W, 2006 aspirin + clopidogrel inferior to anticoagulant in terms of All stroke(ischemic+hemorrhagic/fatal+non fatal) in ACTIVE W, 2006 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
ACTIVE W, 2006 | aspirin + clopidogrel vs anticoagulant | haemorragic stroke(or intracerebral hemorrhage) 0.34 [0.12; 0.93] | non fatal TE events,bleedings and vascular death* 1.39 [1.18; 1.64] thrombo-embolic event (cerebral or systemic) 1.43 [1.18; 1.74] ischemic stroke 2.17 [1.51; 3.11] All stroke(ischemic+hemorrhagic/fatal+non fatal) 1.71 [1.25; 2.36] | all death 1.02 [0.82; 1.26] vascular death 1.14 [0.89; 1.48] major bleeding 1.10 [0.83; 1.45] fatal stroke(ischemic+hemorrhagic) 0.94 [0.46; 1.95] fatal bleeding 0.64 [0.25; 1.66] |
Trial | Treatments | Patients | Method |
---|
ACTIVE W, 2006 | clopidogrel (75 mg per day) plus aspirin (75–100 mg per day) (n=3335) vs. oral anticoagulation therapy (target international normalised ratio of 2·0–3·0) (n=3371) | Patients with atrial fibrillation plus one or more risk factor for stroke | open Parallel groups Sample size: 3335/3371 Primary endpoint: stroke, non-CNS systemic embolus FU duration: 1.28 y (median) |
|
atrial fibrillation | versus antiplatelet drugs No demonstrated result for efficacy aspirin + clopidogrel inferior to aspirin in terms of major bleeding in ACTIVE A, 2009 | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
ACTIVE A, 2009 | aspirin + clopidogrel vs aspirin | fatal stroke(ischemic+hemorrhagic) 0.72 [0.59; 0.88] thrombo-embolic event (cerebral or systemic) 0.90 [0.83; 0.98] ischemic stroke 0.69 [0.59; 0.81] thromboembolic event likes(TE event or ischemic stroke or systemic embolism) 0.89 [0.89; 0.89] All stroke(ischemic+hemorrhagic/fatal+non fatal) 0.73 [0.63; 0.84] | major bleeding 1.57 [1.29; 1.91] | all death 0.98 [0.90; 1.07] vascular death 1.00 [0.91; 1.11] haemorragic stroke(or intracerebral hemorrhage) 1.37 [0.79; 2.37] fatal bleeding 1.56 [0.96; 2.52] |
Trial | Treatments | Patients | Method |
---|
ACTIVE A, 2009 | clopidogrel 75 mg daily + aspirin 75-100 mg daily (n=3772) vs. aspirin 75-100 mg daily alone (n=3782) | Patients with AF and at least one risk factor for stroke and who are not candidates for warfarin therapy | double blind Parallel groups Sample size: 3772/3782 Primary endpoint: stroke, MI, systemic embolus, or vascular death FU duration: 3.7 y |
|
CABG surgery | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CASCADE, 2009 | clopidogrel+aspirin vs aspirin | | | |
Trial | Treatments | Patients | Method |
---|
CASCADE, 2009 | aspirin 162 mg plus clopidogrel 75 mg daily for 1 year (n=56) vs. aspirin 162 mg plus placebo daily (n=57) | patients after CABG involving at least two saphenous vein grafts | double blind Parallel groups Sample size: 56/57 Primary endpoint: vein graft intimal area FU duration: 1 y |
|
cardiovascular prevention | versus aspirin No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CAPRIE (PAD subgroup), 1996 | clopidogrel vs aspirin | IDM fatal 0.62 [0.44; 0.88] IDM totaux 0.63 [0.47; 0.85] | | Mortalité totale 0.81 [0.63; 1.06] AVC fatal 0.95 [0.69; 1.31] AVC non fatal 1.38 [0.55; 3.42] IDM non fatal 0.67 [0.37; 1.21] | CAPRIE, 1996 | clopidogrel vs aspirin | Non fatal MI 0.84 [0.70; 1.00] MI,stroke or CVdeath 0.92 [0.84; 1.00] | | Death from any cause 0.98 [0.87; 1.10] Death from cardiovascular causes 0.92 [0.80; 1.07] severe bleeding 0.88 [0.70; 1.12] non fatal stroke 0.94 [0.82; 1.07] | ASCET | clopidogrel vs aspirin | | | vascular event 0.90 [0.63; 1.29] |
Trial | Treatments | Patients | Method |
---|
CAPRIE (PAD subgroup), 1996 | Clopidogrel 75 mg (n=3223) vs. Aspirine 325 mg (n=3229) | patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease Effectifs correspondant à la strate AOMI | double blind Parallel groups Sample size: 3223/3229 Primary endpoint: Critère composite FU duration: 1.91 y | CAPRIE, 1996 | clopidogrel 75 mg once daily (n=9599) vs. aspirin 325 mg once daily (n=9586) | patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease | Double blind Parallel groups Sample size: 9599/9586 Primary endpoint: ischaemic stroke, myocardial infarction, or vascular death FU duration: mean 1.91 years | ASCET | clopidogrel 75 mg once daily for two years (n=498) vs. Aspirin 160 mg once daily for two years (n=503) | patients with documented coronary heart disease and treated with aspirin platelet function was also assessed at randomization with the PFA100 method and platelet aggregometry | open Parallel groups Sample size: 498/503 Primary endpoint: all-cause death, nonfatal MI, ischemic stroke, and unstable angina FU duration: |
|
cardiovascular prevention | versus placebo or control No demonstrated result for efficacy clopidogrel inferior to placebo (on top aspirin) in terms of moderate bleeding in CHARISMA, 2006 (secondary prevention patients) | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CHARISMA, 2006 | clopidogrel vs placebo (on top aspirin) | non fatal stroke 0.81 [0.65; 1.00] | moderate bleeding 1.62 [1.27; 2.08] | nonfatal Ischemic stroke 0.82 [0.66; 1.04] Death from any cause 0.99 [0.86; 1.14] Death from cardiovascular causes 1.04 [0.87; 1.24] severe bleeding 1.25 [0.97; 1.61] Non fatal MI 0.92 [0.74; 1.15] fatal bleeding 1.53 [0.83; 2.82] MI,stroke or CVdeath 0.93 [0.83; 1.04] |
Trial | Treatments | Patients | Method |
---|
CHARISMA, 2006 | clopidogrel (75 mg per day) plus low-dose aspirin (75 to 162 mg per day) (n=7802) vs. placebo plus low-dose aspirin (n=7801) | patients with either clinically evident cardiovascular disease or multiple risk factors | Double blind Parallel groups Sample size: 7802/7801 Primary endpoint: myocardial infarction, stroke or death from cardiovasculare causes FU duration: median 28 months |
|
coronary artery disease | versus aspirin No demonstrated result for efficacy | 2 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CAPRIE, 1996 | clopidogrel vs aspirin | | | | ASCET | clopidogrel vs aspirin | | | vascular event 0.90 [0.63; 1.29] |
Trial | Treatments | Patients | Method |
---|
CAPRIE, 1996 | Clopidogrel (75 mg) 1x/d for a minimum of one year and a maximum of 3 years (n=9599) vs. Aspirin (325 mg) 1x/d (n=9586) | patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease | Double blind Parallel groups Sample size: 9599/9586 Primary endpoint: ischaemic stroke, myocardial infarction, vascular death FU duration: 1.91 y | ASCET | clopidogrel 75 mg once daily for two years (n=498) vs. Aspirin 160 mg once daily for two years (n=503) | patients with documented coronary heart disease and treated with aspirin platelet function was also assessed at randomization with the PFA100 method and platelet aggregometry | open Parallel groups Sample size: 498/503 Primary endpoint: all-cause death, nonfatal MI, ischemic stroke, and unstable angina FU duration: |
|
percutaneous coronary intervention | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
REAL-LATE, ZEST-LATE, 2010 | clopidogrel+aspirin vs aspirin | | | all cause death 1.52 [0.76; 3.05] major bleeding 2.97 [0.31; 28.51] stroke 2.23 [0.69; 7.21] MI 1.41 [0.54; 3.70] definite stent thrombosis 1.24 [0.33; 4.60] |
Trial | Treatments | Patients | Method |
---|
REAL-LATE, ZEST-LATE, 2010 | clopidogrel plus aspirin (n=1357) vs. aspirin alone (n=1344) | patients who had received drugeluting
stents and had been free of major adverse cardiac or cerebrovascular events
and major bleeding for a period of at least 12 months | open Parallel groups Sample size: 1357/1344 Primary endpoint: CV death, MI FU duration: 19.2 months |
|
percutaneous coronary intervention | versus antiplatelet drugs No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Müller, 2000 | clopidogrel + aspirin vs ticlopidine + aspirin | | | MACE 1.78 [0.67; 4.76] | CLASSICS, 2000 | clopidogrel + aspirin vs ticlopidine + aspirin | | | MACE 1.31 [0.30; 5.83] | TOPPS, 2001 | clopidogrel + aspirin vs ticlopidine + aspirin | | | MACE 0.84 [0.46; 1.51] | Piamsomboon, 2001 | clopidogrel + aspirin vs ticlopidine + aspirin | | | MACE 0.00 [0.00; NaN] |
Trial | Treatments | Patients | Method |
---|
Müller, 2000 | Clopidogrel 75 mg qD x4 wks Aspirin 100 mg qD (n=355) vs. Ticlopidine 250 mg BID x4 wks Aspirin 100 mg qD (n=345) | | Sample size: 355/345 Primary endpoint: FU duration: | CLASSICS, 2000 | Clopidogrel 300mg x1, 75 mg qD x4 wks Aspirin 325 mg qDypñ ·` (n=345) vs. Ticlopidine 250 mg BID x4 wks Aspirin 325 mg qD (n=340) | | Sample size: 345/340 Primary endpoint: FU duration: | TOPPS, 2001 | Clopidogrel 300 mg x1, unsp. Dose x2 wks Aspirin 325 mg qD (n=494) vs. Ticlopidine 500 mg x1, unsp. Dose x2 wks Aspirin 325 mg qD (n=522) | | Sample size: 494/522 Primary endpoint: FU duration: | Piamsomboon, 2001 | Clopidogrel 300 mg x1, 75 mg qD x4 wks Aspirin 300 mg BID x4 wks, 300 mg qD (n=37) vs. Ticlopidine 250 mg po BID x4 wks Aspirin 300 mg BID x4 wks, 300 mg qD (n=31) | | Sample size: 37/31 Primary endpoint: FU duration: |
|
percutaneous coronary intervention | versus standard clopidogrel No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
GRAVITAS, 2011 | high-dose clopidogrel vs normal-dose clopidogrel | | | all cause death 0.70 [0.27; 1.83] Cardiovascular death 0.37 [0.10; 1.40] MI 1.11 [0.59; 2.08] any bleeding 1.17 [0.93; 1.49] GUSTO severe/moderate bleeding 0.60 [0.32; 1.13] Cardiovascular death/MI/stent thrombosis 1.01 [0.58; 1.76] definite stent thrombosis 0.62 [0.20; 1.90] |
Trial | Treatments | Patients | Method |
---|
GRAVITAS, 2011 | High-dose clopidogrel (600-mg initial dose, 150 mg daily thereafter) (n=1109) vs. regular clopidogrel dose (n=1105) | patients receiving drug-eluting stents with high residual platelet activity (PRU>=230) on the regular clopidogrel dose (platelet-function tests with the VerifyNow assay 12 to 24 hours after PCI) | open Parallel groups Sample size: 1109/1105 Primary endpoint: Cardiovascular death/MI/stent thrombosis FU duration: 6 months |
|
peripheral vascular diseases | versus aspirin No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CAPRIE (PAD subgroup), 1996 | clopidogrel vs aspirin | IDM fatal 0.62 [0.44; 0.88] IDM totaux 0.63 [0.47; 0.85] | | Mortalité totale 0.81 [0.63; 1.06] AVC fatal 0.95 [0.69; 1.31] AVC non fatal 1.38 [0.55; 3.42] IDM non fatal 0.67 [0.37; 1.21] |
Trial | Treatments | Patients | Method |
---|
CAPRIE (PAD subgroup), 1996 | Clopidogrel 75 mg (n=3223) vs. Aspirine 325 mg (n=3229) | patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease Effectifs correspondant à la strate AOMI | double blind Parallel groups Sample size: 3223/3229 Primary endpoint: Critère composite FU duration: 1.91 y |
|
post myocardial infarction | versus aspirin No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
CAPRIE, 1996 | clopidogrel vs aspirin | | | |
Trial | Treatments | Patients | Method |
---|
CAPRIE, 1996 | Clopidogrel (75 mg) 1x/d for a minimum of one year and a maximum of 3 years (n=9599) vs. Aspirin (325 mg) 1x/d (n=9586) | patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease | Double blind Parallel groups Sample size: 9599/9586 Primary endpoint: ischaemic stroke, myocardial infarction, vascular death FU duration: 1.91 y |
|
stable angina | versus aspirin No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
ASCET | clopidogrel vs aspirin | | | vascular event 0.90 [0.63; 1.29] |
Trial | Treatments | Patients | Method |
---|
ASCET | clopidogrel 75 mg once daily for two years (n=498) vs. Aspirin 160 mg once daily for two years (n=503) | patients with documented coronary heart disease and treated with aspirin platelet function was also assessed at randomization with the PFA100 method and platelet aggregometry | open Parallel groups Sample size: 498/503 Primary endpoint: all-cause death, nonfatal MI, ischemic stroke, and unstable angina FU duration: |
|
stent | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
REAL-LATE, ZEST-LATE, 2010 | clopidogrel+aspirin vs aspirin | | | all cause death 1.52 [0.76; 3.05] major bleeding 2.97 [0.31; 28.51] stroke 2.23 [0.69; 7.21] MI 1.41 [0.54; 3.70] definite stent thrombosis 1.24 [0.33; 4.60] |
Trial | Treatments | Patients | Method |
---|
REAL-LATE, ZEST-LATE, 2010 | clopidogrel plus aspirin (n=1357) vs. aspirin alone (n=1344) | patients who had received drugeluting
stents and had been free of major adverse cardiac or cerebrovascular events
and major bleeding for a period of at least 12 months | open Parallel groups Sample size: 1357/1344 Primary endpoint: CV death, MI FU duration: 19.2 months |
|
stent | versus antiplatelet drugs No demonstrated result for efficacy | 4 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Müller, 2000 | clopidogrel + aspirin vs ticlopidine + aspirin | | | MACE 1.78 [0.67; 4.76] | CLASSICS, 2000 | clopidogrel + aspirin vs ticlopidine + aspirin | | | MACE 1.31 [0.30; 5.83] | TOPPS, 2001 | clopidogrel + aspirin vs ticlopidine + aspirin | | | MACE 0.84 [0.46; 1.51] | Piamsomboon, 2001 | clopidogrel + aspirin vs ticlopidine + aspirin | | | MACE 0.00 [0.00; NaN] |
Trial | Treatments | Patients | Method |
---|
Müller, 2000 | Clopidogrel 75 mg qD x4 wks Aspirin 100 mg qD (n=355) vs. Ticlopidine 250 mg BID x4 wks Aspirin 100 mg qD (n=345) | | Sample size: 355/345 Primary endpoint: FU duration: | CLASSICS, 2000 | Clopidogrel 300mg x1, 75 mg qD x4 wks Aspirin 325 mg qDypñ ·` (n=345) vs. Ticlopidine 250 mg BID x4 wks Aspirin 325 mg qD (n=340) | | Sample size: 345/340 Primary endpoint: FU duration: | TOPPS, 2001 | Clopidogrel 300 mg x1, unsp. Dose x2 wks Aspirin 325 mg qD (n=494) vs. Ticlopidine 500 mg x1, unsp. Dose x2 wks Aspirin 325 mg qD (n=522) | | Sample size: 494/522 Primary endpoint: FU duration: | Piamsomboon, 2001 | Clopidogrel 300 mg x1, 75 mg qD x4 wks Aspirin 300 mg BID x4 wks, 300 mg qD (n=37) vs. Ticlopidine 250 mg po BID x4 wks Aspirin 300 mg BID x4 wks, 300 mg qD (n=31) | | Sample size: 37/31 Primary endpoint: FU duration: |
|
stent | versus standard clopidogrel No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
GRAVITAS, 2011 | high-dose clopidogrel vs normal-dose clopidogrel | | | all cause death 0.70 [0.27; 1.83] Cardiovascular death 0.37 [0.10; 1.40] MI 1.11 [0.59; 2.08] any bleeding 1.17 [0.93; 1.49] GUSTO severe/moderate bleeding 0.60 [0.32; 1.13] Cardiovascular death/MI/stent thrombosis 1.01 [0.58; 1.76] definite stent thrombosis 0.62 [0.20; 1.90] |
Trial | Treatments | Patients | Method |
---|
GRAVITAS, 2011 | High-dose clopidogrel (600-mg initial dose, 150 mg daily thereafter) (n=1109) vs. regular clopidogrel dose (n=1105) | patients receiving drug-eluting stents with high residual platelet activity (PRU>=230) on the regular clopidogrel dose (platelet-function tests with the VerifyNow assay 12 to 24 hours after PCI) | open Parallel groups Sample size: 1109/1105 Primary endpoint: Cardiovascular death/MI/stent thrombosis FU duration: 6 months |
|