Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

Anticoagulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782270
• Other study ID #: 2022-GSP-QN-11
• Status: Recruiting
• Phase: Phase 4
• Start date: April 11, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Xieraili Tiemuerniyazi, M.D.
• Phone: 010-88322265
• Email: tiemuernyz[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anticoagulation

Intervention

Drug:
• Warfarin
dual antiplatelet therapy combined with warfarin
• DAPT
Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)

Other:
• CE+CABG
Coronary endarterectomy combined with coronary artery bypass grafting

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During 6-month follow-up
Secondary	Bleeding events	The Bleeding Academic Research Consortium (BARC) scale type 2~5 [see in reference].	during 6-month follow-up