- Question
- Is prasugrel, a new thienopyridine, more effective than clopidogrel at preventing ischemic events in patients with acute coronary syndromes who are scheduled to undergo percutaneous coronary intervention?
- Design
- Phase 3, randomized, double-blind (quadruple masking) trial enrolling 13608 patients. Treatment lasted 6 to 15 months.
- Population
- Patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention.
- Intervention
- Prasugrel with a 60-mg loading dose and a 10-mg daily maintenance dose, given with aspirin.
- Control
- Clopidogrel with a 300-mg loading dose and a 75-mg daily maintenance dose, given with aspirin.
- Primary outcome
- Composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The key safety end point was major bleeding.
- Results
- The primary end point occurred in 12.1% with clopidogrel and 9.9% with prasugrel (HR 0.81; 95% CI 0.73 to 0.90; P<0.001). Stent thrombosis was lower with prasugrel (1.1% vs. 2.4%; P<0.001).
- Safety
- Major bleeding was more frequent with prasugrel (2.4% vs. 1.8%; HR 1.32; 95% CI 1.03 to 1.68; P=0.03), as was life-threatening bleeding (1.4% vs. 0.9%; P=0.01) and fatal bleeding (0.4% vs. 0.1%; P=0.002). Overall mortality did not differ significantly between groups.
- Conclusion
- In patients with acute coronary syndromes and scheduled percutaneous coronary intervention, prasugrel reduced ischemic events, including stent thrombosis, at the cost of a higher risk of major bleeding, including fatal bleeding.
- Why it matters
- It showed that more potent platelet inhibition improves ischemic outcomes after coronary intervention, but that this benefit must be weighed against bleeding risk when choosing an antiplatelet agent.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026