Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients

Not Applicable

Recruiting

• Conditions: ACS - Acute Coronary Syndrome
• Interventions: Drug: Colchicine 0.5 MG Oral Tablet Once Daily

• Registration Number: NCT07064109
• Lead Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine

Brief Summary

The aim of this prospective cohort study was to investigate the multi-omics characteristics of the efficacy of colchicine treatment in patients with ACS and to construct a model of efficacy. The main questions the study aims to answer are

- Specific mechanisms of colchicine therapy in patients with ACS; Mechanism-based modelling to identify the population that benefits from colchicine treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• 1. Between the ages of 18 and 80 2. ACS (STEMI or NSTE-ACS) 3. Patients to receive standardised drug therapy 4. able and willing to provide informed consent

Exclusion Criteria

• 1. any contraindication to colchicine or known intolerance to colchicine 2. has been using colchicine for a prolonged period of time for other medical conditions 3. women of childbearing age who are pregnant, breastfeeding or not using effective contraception 4. coronary artery bypass grafting within the last 3 years or planned 5. severe hepatic impairment: elevated serum alanine aminotransferase and/or aminotransferase (ALT) and/or aminotransferase (AST) levels of up to three times the upper limit of normal; 6. severe renal impairment: eGFR <30mL/min/1.73m2 7. thrombocytopenia (platelet count less than 100*10⁹/L) 8. active diarrhoea 9. Infectious diseases: presence of uncontrollable infectious diseases 10. immune-related diseases: known immune diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumours, etc.

11. strong CYP3A4 or P glycoprotein inhibitors (e.g., cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) are already in use and no alternative medications can be administered 12. planning to use systemic anti-inflammatory therapies such as NSAIDs, hormones, immunomodulators and chemotherapeutic agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine treatment group	Colchicine 0.5 MG Oral Tablet Once Daily	hs-CRP \> 3mg/L

Primary Outcome Measures

Name	Time	Method
responder	6 months after enrolment	1. Resolution of Inflammation: A reduction in high-sensitivity C-reactive protein (hs-CRP) levels to \<2.0 mg/L, or a decrease of ≥50% from baseline.; 2. Clinical Stability: No occurrence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent revascularization.; 3. Ventricular Remodeling: This is assessed by parameters such as ventricular volume, wall thickness, left ventricular mass, and LVEF (Left Ventricular Ejection Fraction), measured by cardiac magnetic resonance (CMR) or echocardiography.
Advances in Coronary Artery Physiology and Function	1 year after enrolment	Comparing the change in coronary QFR at baseline and one-year follow-up, the sum of QFR of the three major coronary vessels (anterior descending, circumflex, and right coronary artery) was calculated (3V-QFR), and progression in coronary physiology was defined when 3V-QFR minus baseline 3V-QFR at follow-up was ≤ -0.05

Secondary Outcome Measures

Name	Time	Method
Incidence of MACE within one year	1 year after enrolment	MACE defined as: death (cardiac or non-cardiac), acute myocardial infarction, stroke, ischaemia-driven haemodialysis

Trial Locations

Locations (1)

Shanghai Tongji Hospital; 🇨🇳 Shanghai, China