Colchicine to reduce graft failure after CABG
A Single Center Pilot Trial of Preliminary Effect of Colchicine on Graft Failure in Patients Underwent CABG
This will try daily low-dose colchicine for one year in adults after primary isolated CABG to see if it lowers bypass graft failure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06802926 on ClinicalTrials.gov |
What this trial studies
This pilot, phase 4 interventional trial compares daily oral colchicine (0.5 mg) for 12 months versus no colchicine in patients who have undergone primary isolated CABG. Participants receive clinical follow-up at 1, 6, and 12 months and protocol-driven coronary CT angiography (CCTA) at week 1 and month 12 to document graft outcomes. The study also tests whether it is feasible to run a larger multicenter, adequately powered superiority trial. Outcomes will focus on graft failure rates and feasibility metrics such as recruitment and retention.
Who should consider this trial
Good fit: Adults aged 18 or older who can give informed consent and are within three days of a successful isolated CABG without contraindications to colchicine are ideal candidates.
Not a fit: Patients with colchicine allergy, hematopoietic dysfunction, moderate-to-severe hepatic or renal dysfunction, or those unable to complete follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, colchicine could lower the rate of bypass graft failure and reduce the need for repeat coronary procedures after CABG.
How similar studies have performed: Colchicine has shown benefit in reducing cardiovascular events in other coronary disease trials, but its specific use to prevent CABG graft failure is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age≥18 years old， * Any sex， * Signed informed consent， * Within 3 days after a successful isolated CABG Exclusion Criteria: * Allergy, * Hematopoietic dysfunction, * Moderate to severe hepatic dysfunction, * Moderate to severe renal dysfunction.
Where this trial is running
Shanghai
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Yunpeng Zhu, MD — Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Study coordinator: Yunpeng Zhu, MD
- Email: zyp12220@rjh.com.cn
- Phone: 02164370045
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.