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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanjing First Hospital
  Nanjing, China Recruiting

Study contacts

• Study coordinator: Jun-Jie Zhang
• Email: jameszll@163.com
• Phone: +86-25-52271350

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.