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NCT Number: NCT06802926

Pilot Trial of Colchicine for Graft Failure in 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.

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Key information

Conditions

CABG Colchicine Graft Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Yunepng Zhu, MD

CONTACT

[email protected]

02164370045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colchicine

Drug

Oral Colchicine 0.5mg qd for 1 year

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yunpeng Zhu, MD

CONTACT

[email protected]

02164370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: CoCAB-Pilot

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 31, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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