Comparing blood-thinning treatments after heart surgery
Comparison of Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy
This study is testing if adding a blood thinner called warfarin to standard treatment can help heart surgery patients recover better and avoid problems with their grafts.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05782270 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of anticoagulation therapy with warfarin compared to dual antiplatelet therapy alone in patients undergoing coronary endarterectomy combined with coronary artery bypass grafting. The goal is to determine if adding warfarin can improve clinical outcomes and reduce the risk of graft failure due to the activation of the coagulation cascade after surgery. Adult patients with diffuse coronary artery disease who meet specific eligibility criteria will be enrolled to assess the benefits of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults with diffuse coronary artery disease who are scheduled for coronary endarterectomy combined with coronary artery bypass grafting and can tolerate both dual antiplatelet and anticoagulation therapies.
Not a fit: Patients with a high risk of bleeding or those undergoing other cardiac surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced graft failure rates for patients undergoing complex heart surgeries.
How similar studies have performed: While there is limited evidence on this specific combination of treatments, similar studies have explored anticoagulation in post-surgical settings, indicating potential benefits.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xieraili Tiemuerniyazi, M.D.
- Email: tiemuernyz@mail2.sysu.edu.cn
- Phone: 010-88322265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.