Colchicine Treatment for Non-Flow-Limiting Coronary Plaque by Coronary CTA: A Randomized Controlled Trial (COLOR)

January 16, 2026 updated by: Nanjing First Hospital, Nanjing Medical University

This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate whether an anti-inflammatory medication can help improve heart health in patients with stable coronary artery disease.

  1. Research Question & Hypothesis We aim to determine whether adding low-dose colchicine (0.5 mg once daily) to standard medical treatment can further reduce the risk of major cardiovascular events in patients with chronic coronary syndromes (CCS), especially those with non-flow-limiting coronary plaques detected by coronary CT angiography (CCTA).

    We hypothesize that colchicine, by reducing vascular inflammation, may help prevent future heart attacks, strokes, and the need for coronary revascularization.

  2. Study Population & Design Design: A rigorously designed, prospective, multicenter, randomized (1:1), controlled superiority trial.

    Population: Adults (>18 years) diagnosed with CCS, identified by CCTA as having at least one coronary artery with ≥50% narrowing but without significant impact on blood flow (CT-FFR > 0.80).

    Intervention:

    Intervention Group: Standard guideline-directed medical therapy (GDMT) + colchicine 0.5 mg once daily Control Group: GDMT alone Sample Size: Approximately 3,826 participants, accounting for a 5% dropout rate.

  3. Study Endpoints Primary Endpoint: The occurrence of major adverse cardiovascular or cerebrovascular events (MACCE), including:Cardiovascular death; Ischemic stroke; Non-fatal myocardial infarction; Any coronary revascularization. Assessed for 12 months after the last patient is enrolled.

Secondary Endpoints:Occurrence of MACCE over 36 months. Incidence and time to first occurrence of each event category at 12, 24, and 36 months.

Safety Endpoint: Side effects related to colchicine (e.g., gastrointestinal upset, liver or kidney abnormalities, blood disorders, muscle-related reactions).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3826

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Nanjing, China
        • Recruiting
        • Nanjing First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. The subject (or legal guardian) understands the trial requirements and treatment procedure, and signs the written informed consent before undergoing any protocol-specified examinations or procedures;
  2. Aged ≥18 years;
  3. Clinically diagnosed with chronic coronary syndrome (CCS);
  4. CCTA confirms ≥50% stenosis in at least one epicardial coronary artery, and CT fractional flow reserve (CT-FFR) >0.80.

Exclusion Criteria

  1. Unable or unwilling to provide informed consent;
  2. Unable to complete scheduled follow-up;
  3. Underwent PCI within the past 3 months;
  4. History of coronary artery bypass grafting (CABG);
  5. Diagnosis of acute coronary syndromes (ACS);
  6. No coronary plaque or plaque stenosis <50% (confirmed by CCTA);
  7. Lesion-specific CT-FFR ≤0.80 in at least one major epicardial coronary artery;
  8. Inflammatory bowel disease (Crohn's disease/ulcerative colitis) or chronic diarrhea;
  9. History of gastric ulcer or gastric bleeding;
  10. Pregnant/lactating women or women of childbearing age without effective contraception;
  11. Neuromuscular disease or non-transient creatine kinase (CK) >3×upper limit of normal (ULN) (confirmed by ≥2 lab tests);
  12. Clinically significant non-transient hematological abnormalities (hemoglobin <100 g/L, hematocrit <30%/ >52%, white blood cell count <3×10⁹/L, platelet count <100×10⁹/L; confirmed by ≥2 lab tests);
  13. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² (CKD-EPI formula);
  14. Liver dysfunction (alanine aminotransferase >3×ULN and/or total bilirubin >2×ULN);
  15. Current/planned immunosuppressive therapy;
  16. Long-term colchicine use for other indications;
  17. Definite/suspected colchicine allergy;
  18. Active malignant tumor (expected survival <1 year);
  19. Use of potent CYP3A4/P-glycoprotein inhibitors (e.g., cyclosporine, antiretrovirals, antifungals, erythromycin, clarithromycin) without alternative drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Guideline-Directed Medical Therapy Group
Guideline-directed medical therapy (GDMT) alone Guideline-directed medical therapy is based on the Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndromes in China and includes the following types of drug therapies: antiplatelet drugs (aspirin, indobufen, or clopidogrel); anticoagulant drugs (warfarin or new oral anticoagulants); lipid-lowering drugs (control target: LDL-C < 1.8 mmol/L with a reduction of ≥50% from baseline; for ultra-high-risk patients, LDL-C < 1.4 mmol/L with a reduction of ≥50% from baseline); drugs for relieving symptoms such as β-blockers, nitrates, and calcium channel blockers. The specific drug selection and treatment plan will be adjusted according to the clinician's judgment and the actual situation of the patient.
Experimental: Colchicine plus Guideline-Directed Medical Therapy Group
Guideline-directed medical therapy (GDMT) plus colchicine (0.5 mg once daily) Guideline-directed medical therapy is based on the Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndromes in China and includes the following types of drug therapies: antiplatelet drugs (aspirin, indobufen, or clopidogrel); anticoagulant drugs (warfarin or new oral anticoagulants); lipid-lowering drugs (control target: LDL-C < 1.8 mmol/L with a reduction of ≥50% from baseline; for ultra-high-risk patients, LDL-C < 1.4 mmol/L with a reduction of ≥50% from baseline); drugs for relieving symptoms such as β-blockers, nitrates, and calcium channel blockers. The specific drug selection and treatment plan will be adjusted according to the clinician's judgment and the actual situation of the patient.
Drug: Colchicine combined with Guideline-Directed Medical Therapy
colchicine combined with guideline-directed medical therapy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame: 12 months after enrollment
Composite of cardiovascular death, ischemic stroke, non-fatal myocardial infarction, and any coronary revascularization (follow-up ends when the last enrolled patient completes 12 months of follow-up).
12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20241217-10-KS-02

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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