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

NCT07064109 | Recruiting DMC

• 1 other identifier: TJH-2025-07
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

ACS - Acute Coronary Syndrome

Keywords

ACS; colchicine

Outcome Measures

Primary Outcomes (2)

• Number of responder

  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.

  6 months after enrolment

• Number of Participants with Advances in Coronary Artery Physiology and Function

  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

  1 year after enrolment

Secondary Outcomes (1)

• Incidence of MACE within one year

  1 year after enrolment

Study Arms (2)

Colchicine treatment group

EXPERIMENTAL

Adding low-dose colchicine on the basis of standardized treatment

Drug: Colchicine 0.5 MG Oral Tablet Once Daily

control group

NO INTERVENTION

Standardized treatment

Interventions

Colchicine 0.5 MG Oral Tablet Once Daily DRUG

Colchicine 0.5 MG Oral Tablet Once Daily

Colchicine treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 80
• ACS (STEMI or NSTE-ACS)
• Patients to receive standardised drug therapy
• Able and willing to provide informed consent

You may not qualify if:

• Any contraindication to colchicine or known intolerance to colchicine
• Has been using colchicine for a prolonged period of time for other medical conditions
• Women of childbearing age who are pregnant, breastfeeding or not using effective contraception
• Coronary artery bypass grafting within the last 3 years or planned
• 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
• Severe renal impairment: eGFR \<30mL/min/1.73m2
• Thrombocytopenia (platelet count less than 100\*10⁹/L)
• Active diarrhoea
• Infectious diseases: presence of uncontrollable infectious diseases
• Immune-related diseases: known immune diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumours, etc.
• 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
• Planning to use systemic anti-inflammatory therapies such as NSAIDs, hormones, immunomodulators and chemotherapeutic agents

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Central Study Contacts

Xuebo Liu

CONTACT

13801926702; lxb70@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)