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临床试验/NCT03987373
NCT03987373已完成不适用

Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery: Follow-up Extension

Ruijin Hospital6 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年8月1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
6
主要终点
The time to the first MACE-4 event

研究概览

简要总结

This study will include the subjects who enrolled in DACAB trial (NCT02201771) to observe clinical outcomes 5 years after coronary artery bypass grafting(CABG).

The primary objective is to compare the occurrence of MACE-4 ( a composite of all-cause death, myocardial infarction, stroke, and coronary revascularization) among 3 randomized regimens (T+A, T alone, A alone) in previous DACAB trial within 5 years after CABG.

The secondary objectives are to compare the occurrence of MACE-5( a composite of all-cause death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina); MACE-3 ( a composite of cardiovascular death, myocardial infarction, and stroke); all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization; hospitalization for unstable angina and grafts patency rate among 3 randomized regimens in previous DACAB trial within 5 years after CABG.

The exploratory objectives are to compare the occurrence of MACE-4; MACE-5; MACE-3; all-cause death; cardiovascular death; myocardial infarction; stroke; coronary revascularization and hospitalization for unstable angina between 2 cohorts with or without grafts/vein grafts failure at 1 year angiographic follow-up.

详细描述

This is a non-interventional, observational study designed to compare clinical outcomes 5 years after CABG in subjects enrolled in DACAB trial.

After completing 12-month randomized treatment from DACAB trial, investigators would not make any interventions or impact on subjects'therapeutic strategy. Aspirin monotherapy would be given to most subjects according to the current guidelines. However, other antiplatelet regimens might be given for subjects by their attending physician based on the subject's individual condition. Subjects would spontaneously undergo regular laboratory test , electrocardiogram (ECG), ultrasound cardiography (UCG), coronary computed tomographic angiography (CCTA) or coronary angiography (CAG) and clinical follow-up according to clinical need and their individual condition. At 5-year (± 3 month) after CABG, a face-to-face visit is scheduled to be performed to collect the occurrence of clinical events, including types and time of events.

Some prospective exploratory analysis are planned. According to the 1-year angiographic outcome of all grafts from the DACAB trial, all subjects will be allocated to 2 non-randomized cohorts: Cohort A with at least one graft failure (Fitzgibbon Grade B or O) at 1 year, and Cohort B without any graft failure at 1 year. Then prospective exploratory analysis will be performed to compare the occurrence of MACE-4; MACE-5; MACE-3; and other outcomes between 2 non-randomized cohorts from 1-year angiographic follow-up to 5 years after CABG. Similar analysis will be performed according to the 1-year angiographic outcome of vein grafts only.

Other preplanned subgroup analysis included: baseline gender, baseline age stratification(70 years), baseline status of acute coronary syndrome, history of hypertension, baseline history of diabetes, baseline history of high-density lipoprotein cholesterol, baseline history of high-density lipoprotein (a) cholesterol, baseline history of prior myocardial infarction, baseline history of stroke, baseline history of peripheral vascular disease, Baseline history of COPD , baseline history of CKD-3 or above , baseline history of smoking, baseline left main coronary artery disease, baseline SYNTAX score stratification, baseline EuroSCORE stratification, baseline CABG with or without cardiopulmonary bypass, baseline CABG with or without internal thoracic artery grafts, baseline CABG with or without complete revascularization.

研究设计

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

入排标准

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

入选标准

  • This study will include the subjects who enrolled in DACAB trial

排除标准

  • This study will include the subjects who enrolled in DACAB trial

结局指标

主要结局

The time to the first MACE-4 event

时间窗: within 5 year after CABG

The time to the first occurrence of any MACE-4 event, defined as a composite of all-cause death, myocardial infarction, stroke and coronary revascularization.

次要结局

  • The time to the first MACE-5 event(within 5 year after CABG)
  • The time to the first coronary revascularization(within 5 year after CABG)
  • The rate of grafts failure (Fitzgibbon Grade B+O).(at 5 years after CABG ( if not available, at anytime within 5 year after CABG))
  • The time to the first myocardial infarction(within 5 year after CABG)
  • The time to the first hospitalization for unstable angina.(within 5 year after CABG)
  • The time to the first MACE-3 event(within 5 year after CABG)
  • The time to the first cardiovascular death(within 5 year after CABG)
  • The time to the first stroke(within 5 year after CABG)
  • The time to the first occurrence of all-cause death.(within 5 year after CABG)

研究者

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

Qiang Zhao,MD

Professor and director, Department of Cardiac Surgery,Vice President of Ruijin Hospital

Ruijin Hospital

研究点 (6)

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