Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

Phase 4

Recruiting

• Conditions: Anticoagulation; Coronary Endarterectomy
• Interventions: Drug: Warfarin; Drug: DAPT; Other: CE+CABG

• Registration Number: NCT05782270
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-12
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-03-23
• Study Start: 2023-04-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 202

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAPT+warfarin	DAPT	Intervention group: dual antiplatelet combined with warfarin
DAPT+warfarin	CE+CABG	Intervention group: dual antiplatelet combined with warfarin
DAPT	CE+CABG	Comparison group: dual antiplatelet only
DAPT+warfarin	Warfarin	Intervention group: dual antiplatelet combined with warfarin
DAPT	DAPT	Comparison group: dual antiplatelet only

Primary Outcome Measures

Name	Time	Method
Rate of coronary endarterectomy-targeted graft patency.	6 months postoperatively	Defined as less than 50% stenosis of the coronary endarterectomy target and coronary endarterectomy-targeted graft evaluated through either of coronary computed tomography angiography or coronary angiography.

Secondary Outcome Measures

Name	Time	Method
Bleeding events	during 6-month follow-up	The Bleeding Academic Research Consortium (BARC) scale type 2\~5 \[see in reference\].
Number of patients suffering from major adverse cardiovascular and cerebrovascular events	During 6-month follow-up	Major adverse cardiovascular and cerebrovascular events is defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China