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Recruiting NCT05782270

Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

Phase IV Interventional Anticoagulation Coronary Endarterectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Warfarin, DAPT, CE+CABG.
Who it may be relevant to
Registry conditions: Anticoagulation, Coronary Endarterectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Rate of coronary endarterectomy-targeted graft patency. [Time frame: 6 months postoperatively]
Secondary outcome measures (2)
  • Number of patients suffering from major adverse cardiovascular and cerebrovascular events [Time frame: During 6-month follow-up]
  • Bleeding events [Time frame: during 6-month follow-up]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sc — Beijing

Publications

  • 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: 1 PMID 21670242
  • 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

Identifiers

NCT: NCT05782270 · 2022-GSP-QN-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗