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

December 29, 2025 updated by: Zhu yunpeng, Ruijin Hospital

A Single Center Pilot Trial of Preliminary Effect of Colchicine on Graft Failure in Patients Underwent CABG

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colchicine
Oral Colchicine 0.5mg qd for 1 year
Drug: Colchicine
Oral Colchicine 0.5mg qd for 1 year
No Intervention: Blank control
No Oral Colchicine therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Graft Failure Rate at 1 year
Time Frame: 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.
at 1 year post-CABG

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to first 5-point Major Adverse Cardiovascular Event (MACE-5)
Time Frame: 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.
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
PAF will be detected through continuous electrocardiographic monitoring.
within 7 days post-CABG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Study Chair: Qiang Zhao, MD, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • Principal Investigator: Yunpeng Zhu, MD, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2025-777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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