Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

November 17, 2025 updated by: China National Center for Cardiovascular Diseases

Comparison of Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

202

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100037
        • Recruiting
        • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: DAPT
Comparison group: dual antiplatelet only
Drug: DAPT
Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)
Other: CE+CABG
Coronary endarterectomy combined with coronary artery bypass grafting
Experimental: DAPT+warfarin
Intervention group: dual antiplatelet combined with warfarin
Drug: Warfarin
dual antiplatelet therapy combined with warfarin
Drug: DAPT
Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)
Other: CE+CABG
Coronary endarterectomy combined with coronary artery bypass grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of coronary endarterectomy-targeted graft patency.
Time Frame: 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.
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients suffering from major adverse cardiovascular and cerebrovascular events
Time Frame: 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.
During 6-month follow-up
Bleeding events
Time Frame: during 6-month follow-up
The Bleeding Academic Research Consortium (BARC) scale type 2~5 [see in reference].
during 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2023

Primary Completion (Actual)

September 25, 2025

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-GSP-QN-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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