Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

NCT05782270 | Recruiting Phase 4

• 1 other identifier: 2022-GSP-QN-11
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulation; Coronary Endarterectomy

Keywords

coronary endarterectomy; coronary artery bypass grafting; anticoagulation; antiplatelet

Outcome Measures

Primary Outcomes (1)

• Rate of coronary endarterectomy-targeted graft patency.

  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 Outcomes (2)

• Number of patients suffering from major adverse cardiovascular and cerebrovascular events

  During 6-month follow-up

• Bleeding events

  during 6-month follow-up

Study Arms (2)

DAPT

OTHER

Comparison group: dual antiplatelet only

Drug: DAPT; Other: CE+CABG

DAPT+warfarin

EXPERIMENTAL

Intervention group: dual antiplatelet combined with warfarin

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

Interventions

Warfarin DRUG

dual antiplatelet therapy combined with warfarin

DAPT+warfarin

DAPT DRUG

Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)

DAPT; DAPT+warfarin

CE+CABG OTHER

Coronary endarterectomy combined with coronary artery bypass grafting

DAPT; DAPT+warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (2)

• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

  PMID: 21670242 BACKGROUND

• Tiemuerniyazi X, Yang Z, Yang E, He L, Chen L, Huang S, Nan Y, Song Y, Xu F, Yuan X, Hu Z, Zhao W, Feng W. Postoperative antithrombotic therapy after coronary artery bypass grafting combined with coronary endarterectomy (PATH-CARE): study protocol for a randomised controlled clinical trial. BMJ Open. 2025 Nov 9;15(11):e104950. doi: 10.1136/bmjopen-2025-104950.

  PMID: 41213699 DERIVED

MeSH Terms

Interventions

Warfarin

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Xieraili Tiemuerniyazi, M.D.

CONTACT

010-88322265; tiemuernyz@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 23, 2023
• Study Start: April 11, 2023
• Primary Completion: September 25, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)