| acute coronary syndrome | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TRACER, 2011 | vs placebo (on top standard therapy) | | | |
| Trial | Treatments | Patients | Method |
|---|
| TRACER, 2011 | vorapaxar (SCH 530348) oral tablets; 40-mg loading dose on first day, followed by 2.5 mg once daily for at least 1 year
(n=-9) vs. Placebo (added to the existing standard of care (eg, aspirin, clopidogrel) (n=-9) | patients with acute coronary syndrome | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: CV death, MI, stroke, recurrent ischaemia, urgent revasc FU duration: |
|
| cardiovascular prevention | All results are NS for efficacy inferior to placebo (on top aspirin) in terms of major haemorrhage requiring admission to hospital in TRA-2P TIMI 50, 2012 (secondary prevention patients) inferior to placebo (on top aspirin) in terms of Major hemorrhage in TRA-2P TIMI 50, 2012 (secondary prevention patients) inferior to placebo (on top aspirin) in terms of Intracranial haemorrhage in TRA-2P TIMI 50, 2012 (secondary prevention patients) inferior to placebo (on top aspirin) in terms of Major hemorrhage in TRA-2P TIMI 50 (MI subgroup), 2012 (secondary prevention patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TRA-2P TIMI 50, 2012 | 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 | vs placebo (on top aspirin) | all vascular event 0.84 [0.76; 0.93] | | | | TRA-2P TIMI 50 (MI subgroup), 2012 | 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 | All results are NS for efficacy inferior to placebo (on top aspirin) in terms of major haemorrhage requiring admission to hospital in TRA-2P TIMI 50, 2012 (secondary prevention patients) inferior to placebo (on top aspirin) in terms of Major hemorrhage in TRA-2P TIMI 50, 2012 (secondary prevention patients) inferior to placebo (on top aspirin) in terms of Intracranial haemorrhage in TRA-2P TIMI 50, 2012 (secondary prevention patients) | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| TRA-2P TIMI 50, 2012 | 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) |
|
