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临床试验/NCT03947229
NCT03947229进行中(未招募)4 期

A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial

Yonsei University1 个研究点 分布在 1 个国家目标入组 3,200 人开始时间: 2019年8月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
3,200
试验地点
1
主要终点
Net Adverse Clinical Events (NACE)

研究概览

简要总结

We hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.

详细描述

Patients at high risk for either ischemic or bleeding complications, but who were stable without clinical evetns for 12 months after DES implantation will be included in this study. Eligible patients will be randomized to continue DAPT (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). Randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or <75). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative. All of study subjects will be have an outpatient visit as scheduled in outpatient clinic. Occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months up to 24 months after randomization. Antiplatelet drugs will be open-label and prescribed by attending physician.

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

盲法说明

Antiplatelet drugs will be open-label and prescribed by attending physician.

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Clopidogrel mono-therapy

Active Comparator

After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months.

干预措施: Clopidogrel mono-therapy (Drug)

Dual-antiplatelet therapy

Active Comparator

Patients will receive dual antiplatelet consisting of aspirin and clopidogrel.

干预措施: Dual-antiplatelet therapy (Drug)

结局指标

主要结局

Net Adverse Clinical Events (NACE)

时间窗: 24 months

The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5)

次要结局

  • Each component of net adverse clinical events(24 months)
  • All-cause or cardiovascular mortality(24 months)
  • Major or minor bleeding(24 months)
  • Major adverse cardiac event(24 months)
  • Major adverse cardiac and cerebrovascular event(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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