| cardiovascular prevention | versus placebo or control No demonstrated result for efficacy vorapaxar inferior to placebo (on top aspirin) in terms of major haemorrhage requiring admission to hospital in TRA-2P TIMI 50, 2012 (secondary prevention patients) vorapaxar inferior to placebo (on top aspirin) in terms of Major hemorrhage in TRA-2P TIMI 50, 2012 (secondary prevention patients) vorapaxar inferior to placebo (on top aspirin) in terms of Intracranial haemorrhage in TRA-2P TIMI 50, 2012 (secondary prevention patients) vorapaxar inferior to placebo (on top aspirin) in terms of Major hemorrhage in TRA-2P TIMI 50 (MI subgroup), 2012 (secondary prevention patients) | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TRA-2P TIMI 50, 2012 | vorapaxar vs placebo (on top aspirin) | myocardial infarction 0,84 [0,75; 0,93] all vascular event 0,87 [0,80; 0,94] CV death, MI, stroke 0,87 [0,81; 0,95] | major haemorrhage requiring admission to hospital 1,42 [1,32; 1,52] Major hemorrhage 1,45 [1,21; 1,73] Intracranial haemorrhage 1,92 [1,38; 2,68] | All cause mortality 0,96 [0,85; 1,07] cardiovascular death 0,89 [0,76; 1,05] fatal bleeding 1,45 [0,82; 2,56] Stroke (any) 0,97 [0,83; 1,13] | | TRA-2P TIMI 50 (no prior stroke sub group), 2012 | vorapaxar vs placebo (on top aspirin) | all vascular event 0,84 [0,76; 0,93] | | | | TRA-2P TIMI 50 (MI subgroup), 2012 | vorapaxar vs placebo (on top aspirin) | all vascular event 0,81 [0,73; 0,90] | Major hemorrhage 1,29 [1,02; 1,63] | All cause mortality 0,93 [0,79; 1,09] fatal bleeding 1,56 [0,45; 5,41] Intracranial haemorrhage 1,54 [0,54; 4,34] fatal hemorrhagic stroke 1,53 [0,95; 2,46] net benefit 0,92 [0,36; 2,33] |
| Trial | Treatments | Patients | Method |
|---|
| TRA-2P TIMI 50, 2012 | vorapaxar (SCH 530348) 2.5-mg daily (n=13225) vs. placebo (added to the existing standard of care for preventing heart attack and stroke (eg, aspirin, clopidogrel) (n=13244) | patients with a known history of atherosclerosis (MI, ischemic stroke, or peripheral vascular disease) trial was discontinued in patients who experienced a stroke. The study drug will be continued in patients with previous MI or peripheral disease | double-blind Parallel groups Sample size: 13225/13244 Primary endpoint: CV death, MI, stroke, urgent revascularization FU duration: 2.5 y (median) | | TRA-2P TIMI 50 (no prior stroke sub group), 2012 | vorapaxar (SCH 530348) 2.5-mg daily
(n=20699) vs. placebo (added to the existing standard of care for preventing heart attack and stroke (eg, aspirin, clopidogrel)
(n=0)
| patients with a known history of atherosclerosis (MI, ischemic stroke, or peripheral vascular disease), sub group of patient with no prior stroke
trial was discontinued in patients who experienced a stroke. The study drug will be continued in patients with previous MI or peripheral disease
| double-blind Parallel groups Sample size: 20699/0 Primary endpoint: CV death, MI, stroke, urgent revascularization FU duration: 2.5 y (median)
| | TRA-2P TIMI 50 (MI subgroup), 2012 | vorapaxar (SCH 530348) 2.5-mg daily
(n=8898) vs. placebo (added to the existing standard of care for preventing heart attack and stroke (eg, aspirin, clopidogrel)
(n=8881)
| prespecified subgroup of patients with a qualifying myocardial infarction among the overall population of patients with a known history of atherosclerosis (MI, ischemic stroke, or peripheral vascular disease)
trial was discontinued in patients who experienced a stroke. The study drug will be continued in patients with previous MI or peripheral disease
| double-blind Parallel groups Sample size: 8898/8881 Primary endpoint: CV death, MI, stroke, urgent revascularization FU duration: 2.5 y (median)
|
|
| post myocardial infarction | versus placebo or control No demonstrated result for efficacy vorapaxar inferior to placebo (on top aspirin) in terms of major haemorrhage requiring admission to hospital in TRA-2P TIMI 50, 2012 (secondary prevention patients) vorapaxar inferior to placebo (on top aspirin) in terms of Major hemorrhage in TRA-2P TIMI 50, 2012 (secondary prevention patients) vorapaxar inferior to placebo (on top aspirin) in terms of Intracranial haemorrhage in TRA-2P TIMI 50, 2012 (secondary prevention patients) | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TRA-2P TIMI 50, 2012 | vorapaxar vs placebo (on top aspirin) | myocardial infarction 0,84 [0,75; 0,93] all vascular event 0,87 [0,80; 0,94] CV death, MI, stroke 0,87 [0,81; 0,95] | major haemorrhage requiring admission to hospital 1,42 [1,32; 1,52] Major hemorrhage 1,45 [1,21; 1,73] Intracranial haemorrhage 1,92 [1,38; 2,68] | All cause mortality 0,96 [0,85; 1,07] cardiovascular death 0,89 [0,76; 1,05] fatal bleeding 1,45 [0,82; 2,56] Stroke (any) 0,97 [0,83; 1,13] |
| Trial | Treatments | Patients | Method |
|---|
| TRA-2P TIMI 50, 2012 | vorapaxar (SCH 530348) 2.5-mg daily (n=13225) vs. placebo (added to the existing standard of care for preventing heart attack and stroke (eg, aspirin, clopidogrel) (n=13244) | patients with a known history of atherosclerosis (MI, ischemic stroke, or peripheral vascular disease) trial was discontinued in patients who experienced a stroke. The study drug will be continued in patients with previous MI or peripheral disease | double-blind Parallel groups Sample size: 13225/13244 Primary endpoint: CV death, MI, stroke, urgent revascularization FU duration: 2.5 y (median) |
|
