Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.
Roxana Mehran, Sunil V Rao, Deepak L Bhatt...
https://pubmed.ncbi.nlm.nih.gov/21670242Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID05782270
Comparison of Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy
Led by China National Center for Cardiovascular Diseases · Updated on 2025-11-18
202
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best antithrombotic treatment approach after coronary endarterectomy combined with coronary artery bypass grafting (CE+CABG) in patients with diffuse coronary artery disease. This study compares clinical outcomes between dual antiplatelet therapy alone and dual antiplatelet therapy combined with warfarin, due to concerns that CE exposes subendothelial tissue to blood flow which may trigger blood clotting and increase the risk of graft failure. The trial is a Phase 4 randomized study sponsored by the China National Center for Cardiovascular Diseases. Participants will be randomly assigned to one of two groups: one receiving dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor), and the other receiving dual antiplatelet therapy combined with warfarin. Both groups undergo CE+CABG surgery. The study evaluates treatment effects over a 6-month follow-up period, focusing on graft patency and adverse events. The trial uses single masking to ensure unbiased assessment. During the study, participants will be monitored for coronary graft patency at 6 months after surgery. Researchers will also track major cardiovascular and cerebrovascular events as well as bleeding complications during the 6-month follow-up. Participants must be able to swallow tablets after surgery and will undergo regular clinical evaluations to assess outcomes and safety throughout the study duration.
CONDITIONS
Brief Title
Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients with high bleeding risk (HAS-BLED 64 3)
- Patients undergoing concomitant aortic valve or mitral valve surgery, or undergoing cardiac surgery for the second time
- Emergency surgery
- Serum creatinine >130bcmol/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
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months postoperatively
Participants receive either dual antiplatelet therapy alone or dual antiplatelet therapy combined with warfarin after coronary endarterectomy combined with coronary artery bypass grafting.
Regular visits during the 6-month treatment period
Follow-up
Duration - 6 months postoperatively
Participants are monitored for major adverse cardiovascular and cerebrovascular events as well as bleeding events after treatment.
Visits during the 6-month follow-up period
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
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Research Team
X
Xieraili Tiemuerniyazi, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Postoperative antithrombotic therapy after coronary artery bypass grafting combined with coronary endarterectomy (PATH-CARE): study protocol for a randomised controlled clinical trial.
Xieraili Tiemuerniyazi, Ziang Yang, Enze Yang...
https://pubmed.ncbi.nlm.nih.gov/41213699