Pilot Trial of Colchicine for Graft Failure in CABG

NCT06802926 | Recruiting Phase 4

• 1 other identifier: KY-2025-777
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Whether the oral colchicine therapy may reduce the failure outcome of grafts after CABG.
2. 2.Whether it is feasible to construct a muticenter powered trial to test the superiority hypothesis.
3. 3.Take oral colchicine (0.5mg daily) therapy for 12 months after CABG.
4. 4.Clinical follow-up at Month 1, 6, and 12 after CABG.
5. 5.Protocol-driven CCTA at Week 1 and Month 12 after CABG.

Conditions

CABG; Graft Failure; Colchicine

Outcome Measures

Primary Outcomes (1)

• The Graft Failure Rate at 1 year

  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.

  at 1 year post-CABG

Secondary Outcomes (2)

• The time to first 5-point Major Adverse Cardiovascular Event (MACE-5)

  within 1 year post-CABG

• The rate of new perioperative atrial fibrillationat (PAF) within 1 week after CABG

  within 7 days post-CABG

Study Arms (2)

Colchicine

EXPERIMENTAL

Oral Colchicine 0.5mg qd for 1 year

Drug: Colchicine

Blank control

NO INTERVENTION

No Oral Colchicine therapy

Interventions

Colchicine DRUG

Oral Colchicine 0.5mg qd for 1 year

Colchicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years old，
• Any sex，
• Signed informed consent，
• Within 3 days after a successful isolated CABG

You may not qualify if:

• Allergy,
• Hematopoietic dysfunction,
• Moderate to severe hepatic dysfunction,
• Moderate to severe renal dysfunction.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Qiang Zhao, MD

  Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

  STUDY CHAIR

• Yunpeng Zhu, MD

  Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunpeng Zhu, MD

CONTACT

02164370045; zyp12220@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Clinical Research, Department of Cardiovascular Surgery

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: January 31, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)