Actively Recruiting
Colchicine Treatment for Non-Flow-Limiting Coronary Plaque by Coronary CTA: A Randomized Controlled Trial
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2026-01-20
3826
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding a low-dose anti-inflammatory medication called colchicine to standard medical treatment can improve heart health in adults with stable coronary artery disease. The study focuses on patients with chronic coronary syndromes who have at least one coronary artery narrowed by 50% or more, but without significant impact on blood flow, as determined by coronary CT angiography. The goal is to see if colchicine can reduce major cardiovascular events such as heart attacks and strokes by lowering vascular inflammation. Participants are randomly assigned to one of two groups: one group receives standard guideline-directed medical therapy (GDMT) alone, and the other group receives GDMT plus colchicine at a dose of 0.5 mg once daily. GDMT includes medications like antiplatelet drugs, anticoagulants, lipid-lowering agents, and symptom-relieving drugs, adjusted according to clinical judgment. The trial is conducted at multiple centers and plans to enroll about 3,826 adults. During the study, participants will be monitored for major adverse cardiovascular and cerebrovascular events (MACCE), including cardiovascular death, ischemic stroke, non-fatal heart attacks, and coronary revascularization. These events will be tracked for 12 months after enrollment, with additional assessments up to 36 months for longer-term outcomes. Safety monitoring will check for side effects related to colchicine, such as gastrointestinal problems and blood abnormalities. Participants will have scheduled follow-ups to assess their health and treatment effects.
CONDITIONS
Brief Title
Colchicine Treatment for Non-Flow-Limiting Coronary Plaque by Coronary CTA: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant (or legal guardian) understands the trial and signs informed consent before any procedures
- Aged 18 years or older
- Clinically diagnosed with chronic coronary syndrome (CCS)
- Coronary CT angiography shows at least 50% narrowing in one or more major coronary arteries with CT fractional flow reserve (CT-FFR) greater than 0.80
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Unable to complete scheduled follow-up
- Underwent percutaneous coronary intervention (PCI) within the past 3 months
- History of coronary artery bypass grafting (CABG)
- Diagnosed with acute coronary syndromes (ACS)
- No coronary plaque or plaque narrowing less than 50% by CT angiography
- Lesion-specific CT-FFR 0.80 or less in any major coronary artery
- Inflammatory bowel disease or chronic diarrhea
- History of gastric ulcer or gastric bleeding
- Pregnant or breastfeeding women or women of childbearing age without effective contraception
- Neuromuscular disease or elevated creatine kinase more than three times normal
- Significant hematological abnormalities confirmed by repeated lab tests
- Severe kidney dysfunction with estimated glomerular filtration rate less than 30 mL/min/1.73 m²
- Liver dysfunction with elevated liver enzymes or bilirubin
- Current or planned immunosuppressive therapy
- Long-term colchicine use for other reasons
- Known or suspected allergy to colchicine
- Active cancer with expected survival less than one year
- Use of strong CYP3A4 or P-glycoprotein inhibitors without alternatives available
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months after enrollment
Participants receive colchicine combined with guideline-directed medical therapy or guideline-directed medical therapy alone to manage chronic coronary syndrome.
Regular visits as scheduled by the study team during the treatment period
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, China
Actively Recruiting
Research Team
J
Jun-Jie Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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