ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,045
- 试验地点
- 1
- 主要终点
- Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding
研究概览
简要总结
The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES).
详细描述
The drug-eluting stents (DESs) are currently used in the majority of percutaneous coronary intervention (PCI) procedures. On the other hand, the problems of the first-generation DES (late adverse events, such as very late stent thrombosis) have been pointed out. Dual antiplatelet therapy (DAPT) has become a standard regimen after DES implantation and for fear of very late stent thrombosis, DAPT is frequently performed for 1 year or longer in clinical practice. However, serious hemorrhagic complications associated with a prolonged DAPT duration can bring disadvantages to patients, and it is extremely important to clarify an optimal DAPT duration after DES procedure. Currently, 1-month DAPT regimen after bare metal stent (BMS) implantation is commonly used in clinical practice, producing no major problems. Based on a meta-analysis of recent clinical studies, it has also been reported that the use of Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) reduces the risk of early stent thrombosis by half compared to the use of BMS. There is no necessity to extend antiplatelet therapy after CoCr-EES implantation longer than after BMS implantation, and it is considered possible to use the same 1-month DAPT duration as after BMS implantation. The investigators therefore planned a multicenter, randomized, open-label, controlled study, in which the subjects who have undergone CoCr-EES procedure will be divided into the 1-month DAPT and clopidogrel monotherapy group and the 12-month DAPT and aspirin monotherapy group. Primary endpoint is the incidence of composite events including cardiovascular death, myocardial infarction, stent thrombosis, stroke, and bleeding defined by TIMI major or minor bleeding. At first, the non-inferiority about primary endpoint of 1-month DAPT group will be evaluated at 12 months after index procedure and secondarily, the superiority about primary endpoint of 1-month DAPT group will be evaluated at 5 years after index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent
- •Patients who are capable of oral dual antiplatelet therapy consisting of asprin and P2Y12 receptor antagonist
排除标准
- •Patients requiring oral anticoagulants
- •Patients with medical history of intracranial hemorrhage
- •Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention
- •Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents (Xience) implanted at the time of enrollment
- •Patients comfirmed to have no tolerability to clopidgorel before enrollment
- •Patients requiring continuous administration of antiplaelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
- •Patients with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment
研究组 & 干预措施
1-month DAPT
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists , followed by 59-month clopidogrel monotherapy
干预措施: 1-month DAPT (Drug)
12-month DAPT
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists with 11-month DAPT composed of aspirin and clopidogrel, followed by 48-month aspirin monotherapy
干预措施: 12-month DAPT (Drug)
结局指标
主要结局
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding
时间窗: 12-month
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
次要结局
- Target lesion revasucularization(60-month)
- MACE (Major Adverse Cardiac Events)(60-month)
- Definite stent thrombosis(60-month)
- Coronary artery bypass graft(60-month)
- Any coronary reascluarization(60-month)
- Gastrointestinal complaints(60-month)
- Upper gastrointestinal endoscopic examination or treatment(60-month)
- Composite event of cardiovascular death/myocardial infarction(60-month)
- Cardiovascular death(60-month)
- Target lesion failure(60-month)
- Clinically-driven target lesion revascularization(60-month)
- Non target lesion revascularization(60-month)
- Target vessel revascularization(60-month)
- Stroke(60-month)
- Newly diagnosed cancer(60-month)
- All-cause death(60-month)
- Bleeding complications(60-month)
- Gastrointestinal bleeding(60-month)
- Myocardial infarction(60-month)
- Target vessel failure(60-month)
- Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke(60-month)
- Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group(60-month)
- Composite event of all-cause death/myocardial infarction(60-month)
研究者
Takeshi Morimoto
Professor of Medicine
Kyoto University, Graduate School of Medicine