JPRN-UMIN000019948已完成4 期
ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study - ShorT and OPtimal duration of Dual AntiPlatelet Therapy-2 study(STOPDAPT-2)
Kyoto University, Graduate School of Medicine, Department of Cardiovascular Medicine0 个研究点目标入组 3,045 人开始时间: 2015年11月27日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,045
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •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
研究者
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