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

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.

Conditions

CABG; Graft Failure; Colchicine

Outcome Measures

Primary Outcomes (5)

• Participant recruitment rate

  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.

  From start of enrollment through completion of enrollment (approximately 1 year)

• Informed consent success rate

  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%.

  From screening through completion of enrollment (approximately 1 year)

• Treatment adherence rate

  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%.

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

• 1-year CCTA follow-up completion rate

  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%.

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

• Safety acceptability

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

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

Secondary Outcomes (6)

• 1-year Graft failure rate

  at 1 year post-CABG

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

  within 1 year post-CABG

• 30-days incidence of serious complications

  Within 30 days after surgery

• 1-week new perioperative atrial fibrillationat (PAF) rate

  within 7 days post-CABG

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

  Baseline through 1 year 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: September 2, 2026

Record last verified: 2025-12

Data Sharing

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

Locations

CN (1)