ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study
- Conditions
- Coronary Heart Disease, Angina Pectoris, Myocardial Infarction
- Registration Number
- JPRN-UMIN000019948
- Lead Sponsor
- Kyoto University, Graduate School of Medicine, Department of Cardiovascular Medicine
- Brief Summary
3009 were included in the analysis and assigned to 1500 participants in the 1-month DAPT group and 1509 participants in the 12-month DAPT group. The primary endpoint (composite of cardiovascular death, myocardial infarction, stent thrombosis [ARC definite], stroke, and bleeding [TIMI definition major/minor]) was 2.36% in the 1-month DAPT group and 3.70% in the 12-month DAPT group, with a HR of 0.64 (95% CI 0.42-0.98), indicating non-inferiority (p<0.001) and superiority (p=0.04).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 3045
Not provided
1. Patients requiring oral anticoagulants 2. Patients with medical history of intracranial hemorrhage 3. Patients who have experienced serious complications (MI, stroke, and major bleeding) during hospital stay post-PCI 4. Patients with DES other than Xience implanted in PCI performed at the time of enrollment 5. Patients confirmed to have no tolerability to clopidogrel before enrollment 6. Patients requiring continuous administration of antiplatelet drugs (PDE3 inhibitors, prostaglandin preparations, etc.) other than aspirin and P2Y12 receptor inhibitors (prasugrel, clopidogrel, and ticlopidine) at the time of enrollment 7. Patients with coronary bioabsorbable vascular scaffold (BVS) implanted prior to or at the time of enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method