AnticoagulationPhase 4NCT05782270
Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy
A Phase 4 study testing Warfarin, DAPT and CE+CABG in people with Anticoagulation and Coronary Endarterectomy, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation, Coronary Endarterectomy
- What is being tested?
- Warfarin, DAPT and CE+CABG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2023to 30 May 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
About this study
Official title: 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.
- Conditions
- Anticoagulation, Coronary Endarterectomy
- Being tested
- Warfarin, DAPT, CE+CABG
- Keywords
- coronary endarterectomy, coronary artery bypass grafting, anticoagulation, antiplatelet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
dual antiplatelet therapy combined with warfarin
DAPTDrug
Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)
CE+CABGOther
Coronary endarterectomy combined with coronary artery bypass grafting
| Study group | Role | What they receive |
|---|---|---|
| DAPT | Other | Comparison group: dual antiplatelet only Receives: Drug: DAPT; Other: CE+CABG |
| DAPT+warfarin | Experimental | Intervention group: dual antiplatelet combined with warfarin Receives: Drug: Warfarin; Drug: DAPT; Other: CE+CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months postoperatively
Secondary outcomes (2)
Number of patients suffering from major adverse cardiovascular and cerebrovascular events
Major adverse cardiovascular and cerebrovascular events is defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.
Measured: During 6-month follow-up
Bleeding events
The Bleeding Academic Research Consortium (BARC) scale type 2~5 [see in reference].
Measured: during 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start11 Apr 2023
- Primary completion25 Sep 2025
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782270
- Sponsor's protocol ID
- 2022-GSP-QN-11
- Status last verified
- Nov 2025
- First submitted
- 12 Mar 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
PubMed 21670242Tiemuerniyazi 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.
PubMed 41213699