- Question
- In patients at high ischaemic risk who completed standard dual antiplatelet therapy after percutaneous coronary intervention (PCI) with drug-eluting stents, is clopidogrel monotherapy superior to aspirin monotherapy for long-term maintenance?
- Design
- Multicentre, randomised (1:1), open-label trial conducted at 26 sites in South Korea, with 5506 patients analysed by intention to treat and a median follow-up of 2.3 years.
- Population
- Patients aged 19 years or older at high risk of recurrent ischaemic events (previous myocardial infarction, medication-treated diabetes, or complex coronary lesions) who had completed a standard duration of dual antiplatelet therapy after PCI with drug-eluting stents. The median time from PCI to randomisation was 17.5 months.
- Intervention
- Clopidogrel 75 mg once daily as monotherapy (2752 patients).
- Control
- Aspirin 100 mg once daily as monotherapy (2754 patients).
- Primary outcome
- Cumulative incidence of the composite of death from any cause, myocardial infarction, or stroke.
- Results
- The primary endpoint occurred in 92 patients with clopidogrel and 128 with aspirin (estimated 3-year incidence 4.4% vs 6.6%; HR 0.71, 95% CI 0.54-0.93; p=0.013). Myocardial infarction was less frequent with clopidogrel (HR 0.54, 95% CI 0.33-0.90).
- Safety
- There was no difference in bleeding risk between clopidogrel and aspirin (3.0% vs 3.0% at 3 years; HR 0.97, 95% CI 0.67-1.42), and clopidogrel was not associated with a higher incidence of any adverse event.
- Conclusion
- In high-risk patients who completed dual antiplatelet therapy after PCI, clopidogrel monotherapy significantly reduced the composite of death, myocardial infarction, or stroke compared with aspirin, without an apparent increase in bleeding.
- Why it matters
- It adds evidence supporting a P2Y12 inhibitor rather than aspirin as long-term maintenance antiplatelet therapy in high-risk coronary patients, although it was an open-label trial conducted in a single country.
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 14, 2026