Low-dose colchicine for people with non-flow-limiting coronary plaque seen on CT

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

This trial tests whether taking 0.5 mg of colchicine once daily on top of usual heart medicines can lower the chance of heart attack, stroke, or need for coronary procedures in adults with stable coronary artery disease and non-flow-limiting plaques on coronary CT.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3826 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing)
• Trial ID: NCT07349875 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized (1:1) superiority trial enrolling adults with chronic coronary syndrome and coronary CT angiography–confirmed plaques with ≥50% stenosis but CT-FFR >0.80. Participants are randomized to receive low-dose colchicine (0.5 mg once daily) in addition to guideline-directed medical therapy or to continue guideline therapy alone. The trial follows participants for occurrence of major adverse cardiovascular events such as myocardial infarction, stroke, and coronary revascularization. The goal is to see whether adding an anti-inflammatory treatment reduces future events in this imaging-defined subgroup.

Who should consider this trial

Good fit: Adults (≥18 years) with chronic coronary syndrome, a coronary CT angiogram showing ≥50% stenosis in at least one epicardial artery with CT-FFR >0.80, who can provide consent and complete follow-up are the ideal candidates.

Not a fit: People with flow-limiting lesions (CT-FFR ≤0.80), recent PCI or prior CABG, acute coronary syndrome, inflammatory bowel disease, pregnancy/lactation, or other listed exclusions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding low-dose colchicine could reduce future heart attacks, strokes, and the need for coronary procedures in people with stable CAD and non-flow-limiting plaques.

How similar studies have performed: Previous large trials of low-dose colchicine in coronary disease (for example COLCOT and LoDoCo2) showed reductions in cardiovascular events in certain populations, supporting the anti-inflammatory approach although its benefit in CT-defined non-flow-limiting plaques remains to be shown.

Eligibility criteria

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.

Where this trial is running

Nanjing

• Nanjing First Hospital — Nanjing, China (Recruiting)

Study contacts

• Study coordinator: Jun-Jie Zhang

Conditions Coronary Artery Disease; Chronic coronary syndromes; COLCHICINE; Vulnerable Plaque