NCT07349875RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 20 Jan 2026

Brief summary (registry, in English)

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).

Status (registry): Recruiting
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 3826 (estimated)
First submitted: 29 Dec 2025
Start date: 1 Jan 2026
Primary completion date: 30 Dec 2029
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Diseases: Coronary artery disease
NCT number: NCT07349875

What you commit to

Study type: Interventional · Phase 4
Planned participants: 3826
From 1 Jan 2026 to the primary completion date, 30 Dec 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Current/planned immunosuppressive therapy;
Use of potent CYP3A4/P-glycoprotein inhibitors (e.g., cyclosporine, antiretrovirals, antifungals, erythromycin, clarithromycin) without alternative drugs.

Other illness

History of coronary artery bypass grafting (CABG);
Diagnosis of acute coronary syndromes (ACS);
Inflammatory bowel disease (Crohn's disease/ulcerative colitis) or chronic diarrhea;
History of gastric ulcer or gastric bleeding;
Definite/suspected colchicine allergy;
Active malignant tumor (expected survival \<1 year);

Lab values

Neuromuscular disease or non-transient creatine kinase (CK) \>3×upper limit of normal (ULN) (confirmed by ≥2 lab tests);
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);
Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² (CKD-EPI formula);
Liver dysfunction (alanine aminotransferase \>3×ULN and/or total bilirubin \>2×ULN);

Age

Pregnant/lactating women or women of childbearing age without effective contraception;

Other

Unable or unwilling to provide informed consent;
Unable to complete scheduled follow-up;
Underwent PCI within the past 3 months;
No coronary plaque or plaque stenosis \<50% (confirmed by CCTA);
Lesion-specific CT-FFR ≤0.80 in at least one major epicardial coronary artery;
Long-term colchicine use for other indications;

Who the study is looking for

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;
Aged ≥18 years;
Clinically diagnosed with chronic coronary syndrome (CCS);
CCTA confirms ≥50% stenosis in at least one epicardial coronary artery, and CT fractional flow reserve (CT-FFR) \>0.80.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Nanjing First Hospital Coordinator of this site? Confirm its status	Nanjing	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.