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NCT Number: NCT07064109

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

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.

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Key information

Conditions

ACS - Acute Coronary Syndrome Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Colchicine 0.5 MG Oral Tablet Once Daily

Drug

Colchicine 0.5 MG Oral Tablet Once Daily

Primary outcomes

  1. Number of responder

    Time frame: 6 months after enrolment

    • 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.
    • 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.
    • 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.

  2. Number of Participants with Advances in Coronary Artery Physiology and Function

    Time frame: 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 outcomes

  1. Incidence of MACE within one year

    Time frame: 1 year after enrolment

    MACE defined as: death (cardiac or non-cardiac), acute myocardial infarction, stroke, ischaemia-driven haemodialysis

Study contacts

Contact information is provided by the study sponsor or research team.

Xuebo Liu

CONTACT

[email protected]

13801926702

Sponsors and collaborators

Lead sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Other

Registry information

Official study title

Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in Acute Coronary Syndromes Patients

Acronym: MCM-CATE-ACS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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