Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03987373 |
| Other study ID # |
ESR-18-13658 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
