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Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients
RECRUITINGN/ASponsored by Shanghai Tongji Hospital, Tongji University School of Medicine
Actively Recruiting
PhaseN/A
SponsorShanghai Tongji Hospital, Tongji University School of Medicine
Started2025-07-01
Est. completion2027-07-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07064109
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
Age: 18 Years – 80 YearsHealthy volunteers accepted
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
Conditions2
ACS - Acute Coronary SyndromeHeart Disease
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Actively Recruiting
PhaseN/A
SponsorShanghai Tongji Hospital, Tongji University School of Medicine
Started2025-07-01
Est. completion2027-07-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07064109