Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colchicine 0.5 MG Oral Tablet Once Daily.
- Who it may be relevant to
- Registry conditions: ACS - Acute Coronary Syndrome. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in Acute Coronary Syndromes Patients
Overview
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.
Interventions
- Drug Colchicine 0.5 MG Oral Tablet Once Daily
Colchicine 0.5 MG Oral Tablet Once Daily
Primary outcome measures
- Number of responder [Time frame: 6 months after enrolment]
- Number of Participants with Advances in Coronary Artery Physiology and Function [Time frame: 1 year after enrolment]
Secondary outcome measures (1)
- Incidence of MACE within one year [Time frame: 1 year after enrolment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Tongji Hospital — Shanghai
Identifiers
NCT: NCT07064109 · TJH-2025-07