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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Nanjing First Hospital
RECRUITING
Nanjing
Contact Information
Primary
Jun-Jie Zhang
jameszll@163.com
+86-25-52271350
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 3826
Treatments
No_intervention: Guideline-Directed Medical Therapy Group
Guideline-directed medical therapy (GDMT) alone Guideline-directed medical therapy is based on the Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndromes in China and includes the following types of drug therapies: antiplatelet drugs (aspirin, indobufen, or clopidogrel); anticoagulant drugs (warfarin or new oral anticoagulants); lipid-lowering drugs (control target: LDL-C \< 1.8 mmol/L with a reduction of ≥50% from baseline; for ultra-high-risk patients, LDL-C \< 1.4 mmol/L with a reduction of ≥50% from baseline); drugs for relieving symptoms such as β-blockers, nitrates, and calcium channel blockers. The specific drug selection and treatment plan will be adjusted according to the clinician's judgment and the actual situation of the patient.
Experimental: Colchicine plus Guideline-Directed Medical Therapy Group
Guideline-directed medical therapy (GDMT) plus colchicine (0.5 mg once daily) Guideline-directed medical therapy is based on the Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndromes in China and includes the following types of drug therapies: antiplatelet drugs (aspirin, indobufen, or clopidogrel); anticoagulant drugs (warfarin or new oral anticoagulants); lipid-lowering drugs (control target: LDL-C \< 1.8 mmol/L with a reduction of ≥50% from baseline; for ultra-high-risk patients, LDL-C \< 1.4 mmol/L with a reduction of ≥50% from baseline); drugs for relieving symptoms such as β-blockers, nitrates, and calcium channel blockers. The specific drug selection and treatment plan will be adjusted according to the clinician's judgment and the actual situation of the patient.
Sponsors
Leads: Nanjing First Hospital, Nanjing Medical University

This content was sourced from clinicaltrials.gov