RecruitingNot ApplicableNCT07064109

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

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


Sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Enrollment

380 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria12

  • 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

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Interventions

DRUGColchicine 0.5 MG Oral Tablet Once Daily

Colchicine 0.5 MG Oral Tablet Once Daily


Locations(1)

Shanghai Tongji Hospital

Shanghai, China

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NCT07064109


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