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临床试验/NCT05320926
NCT05320926招募中不适用

Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial

Yonsei University1 个研究点 分布在 1 个国家目标入组 3,744 人开始时间: 2022年7月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
3,744
试验地点
1
主要终点
Net adverse clinical events (NACE)

研究概览

简要总结

Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Therefore, which antiplatelet agent to be maintained after short-term DAPT needs further invstigations.

详细描述

The investigators hypothesized that short-term (1-3 months) DAPT followed by clopidogrel monotherapy will be superior to short-term DAPT followed by aspirin monotherapy after PCI in patients with ischemic heart disease. We will evaluate whether clopidogrel monotherapy will reduce the rate of net adverse clinical events (NACE) at 12 months compared to aspirin monotherapy after very-short term DAPT. Eligible patients will be randomized to short-term DAPT followed by clopidogrel monotherapy or short-term DAPT followed by aspirin monotherapy at hospitalization for index PCI. Randomization will be stratified according to 1) bleeding risk (high bleeding risk [HBR] or non-HBR), 2) clinical presentation (acute coronary syndrome or chronic coronary artery disease), and 3) lesion complexity (non-complex or complex lesion). Regarding the duration of very-short term DAPT, the maintenance duration of DAPT (1-month or 3-month) will be determined as follows:

  • If the patients are at HBR (HBR is defined according to ARC-HBR criteria: meeting at least 1 major or 2 minor criteria), 1-month DAPT will be given regardless of clinical presentation or lesion complexity.
  • In the patients are at non-HBR, 3-month DAPT will be given in those treated for unstable angina and/or complex lesions (complex lesion is defined as meeting at least one of the following: number of stents implanted ≥3, number of lesions treated ≥3, 3-vessel treated, bifurcation PCI with 2 stents, total stent length ≥60mm, or chronic total occlusion).

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

年龄范围
19 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥19 years
  • Patients who received new generation zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease
  • Provision of informed consent

排除标准

  • Age ≥ 85 years
  • Acute myocardial infarction
  • Left main bifurcation requiring 2-stent technique
  • Pregnant women or women with potential childbearing
  • Life expectancy < 1 year
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
  • Inability to understand or read the informed consent

研究组 & 干预措施

Short-term DAPT followed by clopidogrel monotherapy

Experimental

atients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop aspirin and maintain clopidogrel after DAPT.

干预措施: Clopidogrel monotherapy (Drug)

Short-term DAPT followed by clopidogrel monotherapy

Experimental

atients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop aspirin and maintain clopidogrel after DAPT.

干预措施: zotarolimus-eluting stent (Resolute Onyx ®) (Device)

Short-term DAPT followed by aspirin monotherapy

Active Comparator

Arm Description: Patients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop clopidogrel and maintain aspirin after DAPT.

干预措施: Aspirin monotherapy (Drug)

Short-term DAPT followed by aspirin monotherapy

Active Comparator

Arm Description: Patients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop clopidogrel and maintain aspirin after DAPT.

干预措施: zotarolimus-eluting stent (Resolute Onyx ®) (Device)

结局指标

主要结局

Net adverse clinical events (NACE)

时间窗: 1 year after the procedure

Composite of all-cause death, myocardial infarction, stroke, or major bleeding (BARC 2, 3 or 5)

次要结局

  • Target-lesion revascularization(1 year after the procedure)
  • Major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, or stroke)(1 year after the procedure)
  • Target-vessel revascularization(1 year after the procedure)
  • Each component of NACE(1 year after the procedure)
  • Cardiac death(1 year after the procedure)
  • Stent thrombosis (definite or probable)(1 year after the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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