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Completed

NCT Number: NCT03987373

DACAB Trial: Follow-up Extension

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Central China Cardiovascular Hospital, Zhengzhou, Henan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

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.

Primary outcomes

  1. The time to the first MACE-4 event

    Time frame: 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.

Secondary outcomes

  1. The time to the first MACE-5 event

    Time frame: within 5 year after CABG

    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.

  2. The time to the first MACE-3 event

    Time frame: within 5 year after CABG

    The time to first occurrence of any MACE-3 event, defined as a composite of cardiovascular death, myocardial infarction, and stroke.

  3. The time to the first occurrence of all-cause death.

    Time frame: within 5 year after CABG

    The time to occurrence of any death

  4. The time to the first cardiovascular death

    Time frame: within 5 year after CABG

    The time to occurrence of any cardiovascular death

  5. The time to the first myocardial infarction

    Time frame: within 5 year after CABG

    The time to occurrence of any myocardial infarction, including STEMI, NSTEMI, or silent MI.

  6. The time to the first stroke

    Time frame: within 5 year after CABG

    The time to occurrence of any stroke, including ischemic, hemorrhagic, or unknown type.

  7. The time to the first coronary revascularization

    Time frame: within 5 year after CABG

    The time to occurrence of any repeated coronary revascularization, including PCI or CABG, no matter ischemic driven or not.

  8. The time to the first hospitalization for unstable angina.

    Time frame: within 5 year after CABG

    The time to occurrence of any hospitalization for unstable angina. By definition, UA is cardiac biomarker negative with no evidence of AMI.

  9. The rate of grafts failure (Fitzgibbon Grade B+O).

    Time frame: at 5 years after CABG ( if not available, at anytime within 5 year after CABG)

    assessed by CCTA or CAG, including artery and vein grafts.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: DACAB-FE

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 17, 2019
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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