Pilot Trial of Colchicine for Graft Failure in CABG

Phase 4

Not yet recruiting

• Conditions: CABG; Colchicine; Graft Failure
• Interventions: Drug: Colchicine

• Registration Number: NCT06802926
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-26
• Study First Submitted QC: 2025-01-30
• Study First Posted: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Study Start: 2025-07
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine	Colchicine	Oral Colchicine 0.5mg qd for 1 year

Primary Outcome Measures

Name	Time	Method
The Graft Failure Rate at 1 year	at 1 year post-CABG	A protocol-driven CCTA will be used to evaluate the graft outcome at 1 year after CABG. Fitzgibbon Grade B/S/O is definned as graft failure.

Secondary Outcome Measures

Name	Time	Method
The time to first 5-point Major Adverse Cardiovascular Event (MACE-5)	within 1 year post-CABG	MACE-5 is a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and rehospitalization due to unstable angina.
The rate of new perioperative atrial fibrillationat (PAF) within 1 week after CABG	within 7 days post-CABG	PAF will be detected through continuous electrocardiographic monitoring.

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China