AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 4Ages 18 Years - anyAllNanjing First Hospital, Nanjing Medical University
💬

In plain words

What the trial is, and whether it could suit you

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 y

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • Colchicine combined with Guideline-Directed Medical Therapy
📍

Where

1 site
Nanjing First Hospital
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy