Pilot Trial of Colchicine for Graft Failure in CABG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colchicine.
- Who it may be relevant to
- Registry conditions: CABG, Graft Failure, Colchicine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single Center Pilot Trial of Preliminary Effect of Colchicine on Graft Failure in Patients Underwent CABG
Overview
The goal of this pilot trial is to to evaluate the preliminary effect of oral colchicine therapy on graft outcomes in patients underwent primary isolated CABG. The main questions it aims to answer is: 1. Whether the oral colchicine therapy may reduce the failure outcome of grafts after CABG. 2. Whether it is feasible to construct a muticenter powered trial to test the superiority hypothesis. Researchers will compare colchicine to none to see if colchicine works. Participants will 1. Take oral colchicine (0.5mg daily) therapy for 12 months after CABG. 2. Clinical follow-up at Month 1, 6, and 12 after CABG. 3. Protocol-driven CCTA at Week 1 and Month 12 after CABG.
Interventions
- Drug Colchicine
Oral Colchicine 0.5mg qd for 1 year
Primary outcome measures
- The Graft Failure Rate at 1 year [Time frame: at 1 year post-CABG]
Secondary outcome measures (2)
- The time to first 5-point Major Adverse Cardiovascular Event (MACE-5) [Time frame: within 1 year post-CABG]
- The rate of new perioperative atrial fibrillationat (PAF) within 1 week after CABG [Time frame: within 7 days post-CABG]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06802926 · KY-2025-777