Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

• Sponsor: China National Center for Cardiovascular Diseases (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05782270
• Collaborator: (none)
• Enrollment: 202
• Arms: 2
• Anticipated Duration (Months): 27.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation; Coronary Endarterectomy	Drug: Warfarin; Drug: DAPT; Other: CE+CABG	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 202 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy
• Anticipated Study Start Date: Mar 27, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: DAPT Comparison group: dual antiplatelet only	Drug: DAPT; Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor); Other: CE+CABG; Coronary endarterectomy combined with coronary artery bypass grafting
Experimental: DAPT+warfarin Intervention group: dual antiplatelet combined with warfarin	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

Outcome Measures

Primary Outcome Measures

1. Rate of coronary endarterectomy-targeted graft patency. [6 months postoperatively]

   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.

Secondary Outcome Measures

1. Number of patients suffering from major adverse cardiovascular and cerebrovascular events [During 6-month follow-up]

   Major adverse cardiovascular and cerebrovascular events is defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.

2. Bleeding events [during 6-month follow-up]

   The Bleeding Academic Research Consortium (BARC) scale type 2~5 [see in reference].

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• China National Center for Cardiovascular Diseases

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: China National Center for Cardiovascular Diseases
• ClinicalTrials.gov Identifier: NCT05782270
• Other Study ID Numbers: 2022-GSP-QN-11
• First Posted: Mar 23, 2023
• Last Update Posted: Mar 28, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by China National Center for Cardiovascular Diseases: coronary endarterectomy; coronary artery bypass grafting; anticoagulation; antiplatelet
• Additional relevant MeSH terms: Warfarin

Study Results

No Results Posted as of Mar 28, 2023