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

NCT07349875 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3826

Last updated 2026-01-20

No results posted yet for this study

Summary

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).

Conditions

  • Coronary Artery Disease (CAD)

Interventions

DRUG

Colchicine combined with Guideline-Directed Medical Therapy

colchicine combined with guideline-directed medical therapy group

Sponsors & Collaborators

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2029-12-30
Completion
2030-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07349875 on ClinicalTrials.gov