The 10-Year Extended Follow-up of the Different Antiplatelet Strategies After Coronary Artery Bypass Grafting Trial
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
- 否
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
Zhu yunpeng
Director of clinical research, Department of Cardiovascular Surgery
Ruijin Hospital
