Clinical trial NCT05782270: Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy
Official title: Comparison of Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anticoagulation
Coronary Endarterectomy
Keywords: coronary endarterectomy
coronary artery bypass grafting
anticoagulation
antiplatelet
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-03-23
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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.

Primary outcomes:
measure: Rate of coronary endarterectomy-targeted graft patency.
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Number of patients suffering from major adverse cardiovascular and cerebrovascular events
timeFrame: During 6-month follow-up
measure: Bleeding events
timeFrame: during 6-month follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References:
citation: 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.