Actively Recruiting
A Single Center Pilot Trial of Preliminary Effect of Colchicine on Graft Failure in Patients Underwent CABG
Led by Ruijin Hospital · Updated on 2026-01-02
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary effect of oral colchicine therapy on graft outcomes in patients who have undergone primary isolated coronary artery bypass grafting (CABG). The trial aims to determine if colchicine can reduce graft failure after CABG and whether it is feasible to conduct a larger, multicenter trial to test this hypothesis. Participants will be randomly assigned to receive either oral colchicine at a dose of 0.5 mg daily for 12 months or no colchicine therapy. The treatment period lasts for one year following CABG. Clinical follow-up visits are scheduled at 1 month, 6 months, and 12 months after the surgery. Additionally, participants will undergo coronary computed tomography angiography (CCTA) scans at one week and 12 months post-CABG. During the study, participants will be monitored through clinical evaluations and imaging tests to assess graft status and cardiovascular events. The primary outcome measured is the graft failure rate at one year post-CABG. Secondary outcomes include the time to the first major adverse cardiovascular event within one year and the rate of new perioperative atrial fibrillation within one week after surgery. Participants will be followed for the full 12 months to evaluate these outcomes.
CONDITIONS
Brief Title
Pilot Trial of Colchicine for Graft Failure in CABG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Any sex
- Signed informed consent
- Within 3 days after a successful isolated CABG
You will not qualify if you...
- Allergy
- Hematopoietic dysfunction
- Moderate to severe hepatic dysfunction
- Moderate to severe renal dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 days after a successful isolated CABG
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants receive oral Colchicine 0.5mg once daily for 1 year or no Colchicine therapy if in the control group.
Regular visits as scheduled during the 1 year treatment period
Trial Site Locations
Total: 1 location
1
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
Y
Yunpeng Zhu, MD
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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