Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

National Center for Cardiovascular Diseases

Status and phase: Enrolling; Phase 4

Conditions: Anticoagulation; Coronary Endarterectomy

Treatments: Drug: DAPT; Other: CE+CABG; Drug: Warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT05782270

2022-GSP-QN-11

Details and patient eligibility

About

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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

DAPT

Other group

Description:

Comparison group: dual antiplatelet only

Treatment:

Other: CE+CABG

Drug: DAPT

DAPT+warfarin

Experimental group

Description:

Intervention group: dual antiplatelet combined with warfarin

Treatment:

Drug: Warfarin

Other: CE+CABG

Drug: DAPT