drugset / Trial / NCT04418479

SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3

NCT04418479 ↗

Phase 4 Completed 5506 enrolled Joo-Yong Hahn
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more than 12 months for myocardial infarction \[MI\] and more than 6 months for non-MI) after percutaneous coronary intervention (PCI) in patients at high risk of recurrent ischemic events.

Timeline

Start
2020-08-10
Primary completion
2024-10-31
Completion
2024-11-12

Outcome

Met primary endpoint

paper 3-year incidence 4·4% [95% CI 3·4-5·4] vs 6·6% [5·4-7·8]; hazard ratio 0·71 [95% CI 0·54-0·93]; p=0·013 PMID 40174599 ↗

paper clopidogrel monotherapy, compared with aspirin monotherapy, significantly reduced the cumulative incidence of a composite of death from any cause, myocardial infarction, and stroke PMID 40174599 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 100 mg Oral
Subject Clopidogrel Small molecule 75 mg Oral