Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2026-05-30

Brief Summary

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Coronary endarterectomy (CE) combined with coronary artery bypass grafting (CABG) can be the final option for achieving complete revascularization in diffuse coronary artery disease patients. Since the exposure of subendothelial tissue to the blood flow after CE, the coagulation cascade can be activated, resulting in the increased risk of graft failure. Therefore, anticoagulation with warfarin in this group of patients might be beneficial. However, evidence is limited. This study aims to compare the clinical outcomes between dual antiplatelet therapy with or without warfarin after CE+CABG.

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Detailed Description

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Conditions

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Anticoagulation Coronary Endarterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DAPT

Comparison group: dual antiplatelet only

Group Type OTHER

DAPT

Intervention Type DRUG

Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)

CE+CABG

Intervention Type OTHER

Coronary endarterectomy combined with coronary artery bypass grafting

DAPT+warfarin

Intervention group: dual antiplatelet combined with warfarin

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

dual antiplatelet therapy combined with warfarin

DAPT

Intervention Type DRUG

Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)

CE+CABG

Intervention Type OTHER

Coronary endarterectomy combined with coronary artery bypass grafting

Interventions

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Warfarin

dual antiplatelet therapy combined with warfarin

Intervention Type DRUG

DAPT

Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)

Intervention Type DRUG

CE+CABG

Coronary endarterectomy combined with coronary artery bypass grafting

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients with diffuse coronary artery disease undergoing CE+CABG during the study period.
* No contraindications for both dual antiplatelet therapy and anticoagulation therapy with warfarin.
* Must be able to swallow tablets after the surgery.

Exclusion Criteria

1. Patients with high bleeding risk (HAS-BLED ≥ 3);
2. Patients undergoing concomitant aortic valve or mitral valve surgery, or undergoing cardiac surgery for the second time;
3. Emergency surgery;
4. Serum creatinine \>130μmol/L, or significant liver dysfunction (elevated ALT and/or AST);
5. History of digestive or urinary tract bleeding, active gastric bleeding caused by gastric ulcer, or postoperative new-onset gastric bleeding;
6. History of hemorrhagic stroke, or platelet dysfunction;
7. Allergic or with contraindication to any of aspirin, clopidogrel or warfarin;
8. Participated in other clinical trial for drug or device within 30 days;
9. Pregnant or planning to be pregnant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No