Low-dose Colchicine for CABG Graft Failure Prevention

NCT07569328 | Not Yet Recruiting DMC

• 1 other identifier: TACTIC-II
• Study Type: interventional
• Target: 622
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether daily low-dose colchicine (0.5 mg), administered in addition to the standard secondary prevention regimen recommended in clinical guidelines after coronary artery bypass grafting (CABG), can further prevent graft failure after CABG through a prospective, randomized, double-blind, placebo-controlled clinical trial.

Conditions

CAD - Coronary Artery Disease; CABG; Colchicine

Outcome Measures

Primary Outcomes (1)

• graft failure rate

  At 24 months postoperatively, all patients who complete the study will undergo coronary computed tomographic angiography (CCTA) to assess graft patency, calculated as 1 minus graft failure rate, where graft failure rate = (number of grafts graded B or O according to the Fitzgibbon classification / total number of grafts) × 100%.

  2 year after randomization

Secondary Outcomes (1)

• MACCE

  2 year after randomization

Study Arms (2)

Colchicine group

EXPERIMENTAL

Patients are randomized within 3 days after successful isolated CABG, and on the day of randomization, eligible patients receive guideline-directed standard secondary prevention therapy plus colchicine (0.5 mg qd) starting as soon as possible (within 24 hours) and continuing for 24 months.

Drug: Colchicine Pill

Placebo group

PLACEBO COMPARATOR

Patients are randomized within 3 days after successful isolated CABG, and on the day of randomization, eligible patients receive guideline-directed standard secondary prevention therapy plus matching placebo (1 tablet qd) starting as soon as possible (within 24 hours) and continuing for 24 months.

Drug: Placebo

Interventions

Colchicine Pill DRUG

Colchicine 0.5 mg once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.

Also known as: Colchicine 0.5 MG

Colchicine group

Placebo DRUG

Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.

Placebo group

Eligibility Criteria

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

You may qualify if:

• Be male or female, aged 18 years or older;
• Within 3 days after successful isolated coronary artery bypass grafting (CABG);
• Sign informed consent;

You may not qualify if:

• Severe valvular heart disease requiring concomitant or staged valvular surgery;
• History of non-skin cancer in the past 3 years;
• Inflammatory bowel disease or chronic diarrhea;
• Neuromuscular diseases or non-transient creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);
• Clinically significant non-transient (At least 2 laboratory tests) blood abnormalities (Hemoglobin \<100g/L or hematocrit \< 30% or \> 52% or white blood cell count \< 3×109/L or platelet count \< 100×109/L);
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² (based on the CKDEPI formula);
• Serum alanine aminotransferase and/or aspartate aminotransferase levels greater than 2 times the upper limit of the normal range, accompanied by serum total bilirubin levels greater than 2 times the upper limit of the normal range or severe liver disease with coagulation disorders (INR\>1.5) (except for elevated glutamic oxalacetic transaminase associated with myocardial infarction);
• Decline in cognitive function due to inability to perform basic activities of daily living independently;
• Drug or alcohol abuse;
• Other immunosuppressive therapies already in existence or planned;
• Other causes require long-term colchicine treatment;
• History of clear or suspected colchicine allergy;
• Strong CYP3A4 or P-glycoprotein inhibitors (such as cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) have been used and no other alternative drugs can be used.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Central Study Contacts

Xiaoli Liu, PhD, MD

CONTACT

8613581633895; liuxiaoli@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)