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Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

StatusRecruiting
PhasePhase 4
Started2023-04-11
View on ClinicalTrials.gov ↗

Amendment history

2025-11-17
Study Status, Oversight v6
Primary completion dateestimated 2025-10-31→confirmed 2025-09-25
Completion date2025-10-31→2026-05-30
2025-04-02
Study Status, Oversight v5
Primary completion date2024-12-31→2025-10-31
Completion date2025-06-30→2025-10-31
2023-08-04
Study Status, IPDSharing v4
Re-verified, no change to tracked fields
2023-05-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-03-27→confirmed 2023-04-11
Study sites0→1
2023-03-26
Study Status v2
Start date2023-03-15→2023-03-27
2023-03-24
Study Status, Arms and Interventions, Outcome Measures, Eligibility, References v1
InterventionsWarfarin (Drug)→CE+CABG (Other), DAPT (Drug), Warfarin (Drug)
Eligibility criteria+187 characters
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-BL [...]
Secondary endpoints2 entries, revised
Number of patients suffering from major adverse cardiovascular and cerebrovascular events bleedingBleeding events
Primary endpoints1 entry, revised
patencyRate of CEcoronary endarterectomy-targeted graft patency.
Publications1 to 2 entries
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 rep [...]
2023-03-22
Original filing
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.
Trial Details
NCT Number NCT05782270
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Anticoagulation, Coronary Endarterectomy
Enrollment 202 participants
Start Date 2023-04-11
Primary Completion 2025-09-25 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-18