Low-dose Colchicine for CABG Graft Failure Prevention

Low-dose Colchicine for CABG Graft Failure Prevention: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: CABG; Colchicine; CAD - Coronary Artery Disease
• Intervention / Treatment: Drug: Colchicine Pill; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 622
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoli Liu, PhD, MD; Phone Number: 8613581633895; Email: liuxiaoli@ccmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Severe valvular heart disease requiring concomitant or staged valvular surgery;
2. History of non-skin cancer in the past 3 years;
3. Inflammatory bowel disease or chronic diarrhea;
4. 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);
5. 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);
6. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² (based on the CKDEPI formula);
7. 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);
8. Decline in cognitive function due to inability to perform basic activities of daily living independently;
9. Drug or alcohol abuse;
10. Other immunosuppressive therapies already in existence or planned;
11. Other causes require long-term colchicine treatment;
12. History of clear or suspected colchicine allergy;
13. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colchicine group; 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; Colchicine 0.5 mg once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.; Other Names: Colchicine 0.5 MG
Placebo Comparator: Placebo group; 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; Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	Major adverse cardiovascular and cerebrovascular events include cardiovascular death, non-fatal ischemic stroke, non-fatal spontaneous (non-operating-related) myocardial infarction, readmission for acute coronary syndrome, and Coronary revascularization	2 year after randomization

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Heterocyclic Compounds; Alkaloids; Colchicine
• Other Study ID Numbers: TACTIC-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No