NCT07349875

Brief 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. 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).
  2. 2.Study Population \& Design Design: A rigorously designed, prospective, multicenter, randomized (1:1), controlled superiority trial.
  3. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,826

participants targeted

Target at P75+ for phase_4

Timeline
51mo left

Started Jan 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jan 2026Jun 2030

First Submitted

Initial submission to the registry

December 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

December 29, 2025

Last Update Submit

January 16, 2026

Conditions

Coronary Artery Disease (CAD)

Keywords

Chronic coronary syndromesCoronary Artery Disease (CAD)Coronary Artery DiseaseCOLCHICINEVulnerable Plaque

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular and cerebrovascular events (MACCE)

    Composite of cardiovascular death, ischemic stroke, non-fatal myocardial infarction, and any coronary revascularization (follow-up ends when the last enrolled patient completes 12 months of follow-up).

    12 months after enrollment

Study Arms (2)

Guideline-Directed Medical Therapy Group

NO INTERVENTION

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.

Colchicine plus Guideline-Directed Medical Therapy Group

EXPERIMENTAL

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.

Drug: Colchicine combined with Guideline-Directed Medical Therapy

Interventions

Colchicine combined with Guideline-Directed Medical TherapyDRUG

colchicine combined with guideline-directed medical therapy group

Colchicine plus Guideline-Directed Medical Therapy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable or unwilling to provide informed consent;
  • Unable to complete scheduled follow-up;
  • Underwent PCI within the past 3 months;
  • History of coronary artery bypass grafting (CABG);
  • Diagnosis of acute coronary syndromes (ACS);
  • No coronary plaque or plaque stenosis \<50% (confirmed by CCTA);
  • Lesion-specific CT-FFR ≤0.80 in at least one major epicardial coronary artery;
  • Inflammatory bowel disease (Crohn's disease/ulcerative colitis) or chronic diarrhea;
  • History of gastric ulcer or gastric bleeding;
  • Pregnant/lactating women or women of childbearing age without effective contraception;
  • 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);
  • Current/planned immunosuppressive therapy;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Jun-Jie Zhang

CONTACT

+86-25-52271350jameszll@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 20, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

June 30, 2030

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)