DACAB Trial: Follow-up Extension

Coronary Artery Bypass Grafting Clinical Trial

— DACAB-FE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987373
• Other study ID #: ESR-18-13658
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: March 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Antiplatelet Therapy
• Coronary Artery Bypass Grafting

Intervention

Other:
• non-interventional
This study is a non-interventional, observational study. After completing 12-month treatment from DACAB trial, investigators would not make any interventions or impact on subjects' therapeutic strategy.

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nan Jing First Hospital	Nanjing	Jiangsu
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Xinhua Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to the first MACE-4 event	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.	within 5 year after CABG
Secondary	The time to the first MACE-5 event	The time to first occurrence of any MACE-5 event, defined as a composite of all-cause death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina.	within 5 year after CABG
Secondary	The time to the first MACE-3 event	The time to first occurrence of any MACE-3 event, defined as a composite of cardiovascular death, myocardial infarction, and stroke.	within 5 year after CABG
Secondary	The time to the first occurrence of all-cause death.	The time to occurrence of any death	within 5 year after CABG
Secondary	The time to the first cardiovascular death	The time to occurrence of any cardiovascular death	within 5 year after CABG
Secondary	The time to the first myocardial infarction	The time to occurrence of any myocardial infarction, including STEMI, NSTEMI, or silent MI.	within 5 year after CABG
Secondary	The time to the first stroke	The time to occurrence of any stroke, including ischemic, hemorrhagic, or unknown type.	within 5 year after CABG
Secondary	The time to the first coronary revascularization	The time to occurrence of any repeated coronary revascularization, including PCI or CABG, no matter ischemic driven or not.	within 5 year after CABG
Secondary	The time to the first hospitalization for unstable angina.	The time to occurrence of any hospitalization for unstable angina. By definition, UA is cardiac biomarker negative with no evidence of AMI.	within 5 year after CABG
Secondary	The rate of grafts failure (Fitzgibbon Grade B+O).	assessed by CCTA or CAG, including artery and vein grafts.	at 5 years after CABG ( if not available, at anytime within 5 year after CABG)