Table 1.
Clinical trials of vorapaxar used in patients with cardiovascular diseases
| TRACER24 (n=12,944) | TRA 2P-TIMI 5032 (n=26,449) | |
|---|---|---|
| Study design | Randomized, double blinded, controlled | Randomized, double blinded, controlled |
| Intervention | Vorapaxar 40 mg loading dose followed by 2.5 mg daily versus placebo | Vorapaxar 2.5 mg daily versus placebo |
| Patient population | Patients presented NSTE-ACS within past 24 hours | Patients with a history of atherosclerosis (MI or ischemic stroke within 2 weeks–12 months or PAD associated with intermittent claudication and an ankle brachial index <0.85 or previous revascularization for limb ischemia) |
| Primary end points | Composite of cardiovascular death, MI, stroke, and recurrent ischemia with urgent coronary revascularization | Composite of death from cardiovascular causes, MI, or stroke |
| Results | Primary end points: placebo 19.9%, vorapaxar 18.5% (HR 0.92, 95% CI 0.85–1.01, P=0.07) | Primary end points: placebo 10.5%, vorapaxar 9.3% (HR 0.87, 95% CI 0.8–0.94, P<0.001) |
| GUSTO moderate or severe bleeding: placebo 5.2%, vorapaxar 7.2% (HR 1.35, 95% CI 1.16–1.58, P<0.05) | GUSTO moderate or severe bleeding: placebo 2.5%, vorapaxar 4.2% (HR 1.66, 95% CI 1.43–1.93, P<0.05) | |
| Clinically significant TIMI bleeding: placebo 14.6%, vorapaxar 20.2% (HR 1.43, 95% CI 1.31–1.57, P<0.05) | Clinically significant TIMI bleeding: placebo 0.5%, vorapaxar 1% (HR 1.94, 95% CI 1.39–2.70, P<0.05) | |
| ICH: placebo 0.2%, vorapaxar 1.1% (HR 3.39, 95% CI 1.78–6.48, P<0.05) | ICH: placebo 0.5%, vorapaxar 1% (HR 1.94, 95% CI 1.39–2.70, P<0.001) |
Notes: P-values calculated using Cox proportional-hazards model.
Abbreviations: TRACER, Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome; TRA 2P-TIMI 50, Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events – Thrombolysis in Myocardial Infarction 50; NSTE-ACS, Non-ST-segment elevation acute coronary syndrome; MI, myocardial infarction; PAD, peripheral arterial disease; HR, hazard ratio; CI, confidence interval; GUSTO, Global Use of Strategies to Open Occluded Arteries; TIMI, thrombolysis in myocardial infarction; ICH, intracranial hemorrhage.