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临床试验/NCT07480629
NCT07480629已完成不适用

The 10-Year Extended Follow-up of the Different Antiplatelet Strategies After Coronary Artery Bypass Grafting Trial

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
4-Point Major Adverse Cardiovascular Events (4P-MACE)

研究概览

简要总结

The goal of this observational study is to learn about the very long-term effects of different antiplatelet strategies in patients who underwent coronary artery bypass grafting (CABG) and participated in the original DACAB trial. The main questions it aims to answer are:

Does one year of treatment with ticagrelor plus aspirin (dual antiplatelet therapy) after CABG reduce the risk of major adverse cardiovascular events (MACE) over 10 years compared with aspirin alone or ticagrelor alone?

What are the long-term safety outcomes, including major bleeding events, among patients who received different antiplatelet strategies?

Researchers will compare the three originally randomized groups (ticagrelor plus aspirin, ticagrelor alone, and aspirin alone) to see if a one-year course of dual antiplatelet therapy provides a sustained clinical benefit over a decade.

Participants will:

Be contacted by telephone by the central study team for a one-time follow-up interview.

Provide information about their current health status, any cardiovascular events (such as heart attack, stroke, or repeat revascularization procedures) that have occurred since the last follow-up.

Report their current use of medications, including antiplatelet and other cardiovascular drugs.

Allow researchers to request relevant medical records to verify any reported clinical events.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Original enrollment and randomization in the DACAB trial

排除标准

  • Who explicitly refuse to provide informed consent for the 10-year follow-up

研究组 & 干预措施

Ticagrelor Plus Aspirin Group

Patients originally randomized to receive ticagrelor 90 mg twice daily plus aspirin 100 mg once daily for one year after CABG in the DACAB trial

Ticagrelor Monotherapy Group

Patients originally randomized to receive ticagrelor 90 mg twice daily for one year after CABG in the DACAB trial.

Aspirin Monotherapy Group

Patients originally randomized to receive aspirin 100 mg once daily for one year after CABG in the DACAB trial.

结局指标

主要结局

4-Point Major Adverse Cardiovascular Events (4P-MACE)

时间窗: From randomization to completion of 10-year follow-up

Time from randomization to the first occurrence of a composite of all-cause death, myocardial infarction, stroke, or coronary revascularization.

次要结局

  • 5P-MACE(From randomization to completion of 10-year follow-up)
  • 3P-MACE(From randomization to 10-year follow-up)
  • All-Cause Death(From randomization to 10-year follow-up)
  • Cardiovascular Death(From randomization to 10-year follow-up)
  • Myocardial Infarction(From randomization to 10-year follow-up)
  • Stroke(From randomization to 10-year follow-up)
  • Coronary Repeat Revascularization(From randomization to 10-year follow-up)
  • Other Cardiovascular-Related Rehospitalization(From randomization to 10-year follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhu yunpeng

Director of clinical research, Department of Cardiovascular Surgery

Ruijin Hospital

研究点 (1)

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