Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06802926

Pilot Trial of Colchicine for Graft Failure in CABG

This is a single-center, prospective, randomized, open-label, assessor-blinded, blank-controlled exploratory (pilot) trial evaluating the feasibility of oral colchicine after coronary artery bypass grafting (CABG). Graft failure and cardiovascular events remain common after CABG, and the anti-inflammatory drug colchicine has shown cardiovascular benefit in chronic coronary disease but has not been adequately studied after CABG.

Approximately 100 adults (aged 18 years and older, any sex) who have undergone first-time isolated CABG, are clinically stable within 3 days after surgery, and are able to take oral medications will be enrolled. Participants will be randomized 1:1 to receive oral colchicine 0.5 mg once daily, initiated within 3 days after surgery and continued for up to 1 year, or no colchicine (blank control).

The primary objective is to assess the feasibility of oral colchicine after CABG, including participant recruitment rate, informed consent rate, treatment adherence, 1-year follow-up completion rate (coronary CT angiography review rate), and safety acceptability, to provide feasibility evidence and sample size estimation parameters for a future multicenter confirmatory randomized controlled trial. Secondary and exploratory objectives include preliminary comparisons of 1-year graft failure (Fitzgibbon B/S/O grades), major adverse cardiovascular events (MACE-5), serious complications of interest, new-onset perioperative atrial fibrillation/flutter, changes in high-sensitivity C-reactive protein and neutrophil-to-lymphocyte ratio, and the incidence of diarrhea and serious infection.

Each participant will be followed for 1 year after surgery.

Recruiting

Interested in participating?

Request Info

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. Participant recruitment rate

    Time frame: From start of enrollment through completion of enrollment (approximately 1 year)

    Average number of participants randomized per month, from start of enrollment to completion of enrollment. Go/no-go (traffic-light) thresholds: Green ≥12 per month; Amber 7-11 per month; Red <7 per month.

  2. Informed consent success rate

    Time frame: From screening through completion of enrollment (approximately 1 year)

    Number of participants who signed informed consent divided by number screened. Go/no-go (traffic-light) thresholds: Green ≥60% and ≤85%; Amber ≥45%and<60%; Red <45% or >85%.

  3. Treatment adherence rate

    Time frame: From randomization through 1 year post-CABG (end of study follow-up)

    Proportion of participants who are adherent to the assigned treatment (number of adherent participants divided by total number of participants). Go/no-go (traffic-light) thresholds: Green ≥95%; Amber ≥85%and<95%; Red <85%.

  4. 1-year CCTA follow-up completion rate

    Time frame: From randomization through 1 year post-CABG (end of study follow-up)

    Proportion of participants who complete coronary CT angiography (CCTA) graft assessment at 1 year after CABG surgery. Go/no-go (traffic-light) thresholds: Green ≥90%; Amber ≥80% and <90%; Red <80%.

  5. Safety acceptability

    Time frame: From randomization through 1 year post-CABG (end of study follow-up)

    Incidence of colchicine-related serious adverse events (SAEs). Go/no-go (traffic-light) thresholds: Green ≤4%; Amber >4% and ≤8%; Red >8%.

Secondary outcomes

  1. 1-year Graft failure rate

    Time frame: at 1 year post-CABG

    Incidence of graft failure at 1 year after CABG, assessed by coronary CT angiography (CCTA). Graft failure is defined as modified Fitzgibbon Grade B (stenosis ≥50%), Grade S (string sign), or Grade O (occlusion).

  2. 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.

  3. 30-days incidence of serious complications

    Time frame: Within 30 days after surgery

    Incidence of pre-specified serious complications within 30 days after surgery, including: cardiac arrest (requiring cardiopulmonary resuscitation); reoperation (bleeding-related or other causes); incision complications (superficial or deep); pulmonary infection (requiring prolonged or escalated antibiotic therapy); respiratory failure (requiring re-intubation or tracheostomy); permanent pacemaker implantation; major gastrointestinal bleeding; and new-onset renal failure (requiring dialysis).

  4. 1-week new perioperative atrial fibrillationat (PAF) rate

    Time frame: within 7 days post-CABG

    PAF will be detected through continuous electrocardiographic monitoring.

  5. Change in high-sensitivity C-reactive protein (hs-CRP) and neutrophil-to-lymphocyte ratio (NLR)

    Time frame: Baseline through 1 year post-CABG

    Changes in hs-CRP and NLR from baseline at 7 days, 30 days, 6 months, and 12 months after surgery, reported as absolute change and percentage change from baseline.

  6. Incidence of diarrhea and serious infection

    Time frame: Within 1 year post-CABG

    Incidence of diarrhea (drug-related change in bowel habits, such as increased frequency or loose stools) and serious infection (infection confirmed by microbiological, pathological, and/or imaging examination and requiring intravenous antibiotics) within 1 year after surgery.

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
Sep 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.