Pilot Trial of Colchicine for Graft Failure in CABG (CoCAB-Pilot)

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 4

Conditions: Graft Failure; Colchicine; CABG

Treatments: Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT06802926

KY-2025-777

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Colchicine

Experimental group

Description:

Oral Colchicine 0.5mg qd for 1 year

Treatment:

Drug: Colchicine

Blank control

No Intervention group

Description:

No Oral Colchicine therapy