No phaseRecruiting
Aspirin 50mg vs 100mg Combined With P2Y12 Inhibitor After PCI (ASPIRE-LD)
The Efficacy and Safety of Aspirin 50mg Versus 100mg in Combination With a P2Y12 Inhibitor After Percutaneous Coronary Intervention: A Randomized, Open-label, Active-controlled, Non-inferiority Trial
- Sponsor
- Jilin University (Academic or other)
- Enrolment
- 2,640 planned
- Conditions
- Coronary Artery Disease; Acute Coronary Syndromes; Chronic Coronary Syndrome; Percutaneous Coronary Intervention
- Interventions
- Aspirin; P2Y12 inhibitor
- Ages
- adults, older adults
- Registry
- NCT07846462
From the registry
This is a randomized, open-label, active-controlled, non-inferiority clinical trial (the ASPIRE-LD trial) conducted in China. It aims to compare the efficacy and safety of low-dose aspirin (50 mg once daily) versus standard-dose aspirin (100 mg once daily), both in combination with a P2Y12 inhibitor, in patients who have successfully undergone percutaneous coronary intervention (PCI) and plan to receive at least 12 months of dual antiplatelet therapy (DAPT). A total of 2640 eligible patients will be randomly assigned in a 1:1 ratio to receive either 50 mg or 100 mg of enteric-coated aspirin daily, plus a P2Y12 inhibitor (ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily, prescribed according to routine clinical practice). All participants will be followed for 12 months after randomization. The primary goal is to verify that 50 mg aspirin is non-inferior to the 100 mg standard dose in preventing major adverse cardiac and cerebrovascular events (MACCE: cardiovascular death, non-fatal myocardial infarction, definite/probable stent thrombosis, and ischemic stroke) at 12…
Primary outcomes
- Incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE)