Multi-omics analysis of colchicine effects in acute coronary syndrome patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective cohort will enroll adults (18–80) with STEMI or NSTE-ACS who receive standard therapy plus colchicine 0.5 mg daily and collect clinical data and biospecimens over time. Researchers will perform multi-omics profiling (for example genomics, transcriptomics, proteomics, and metabolomics) to map molecular changes associated with treatment response. The multi-omics data will be integrated to construct models that identify biological signatures of responders versus non-responders to colchicine. The work is based at Shanghai Tongji Hospital and emphasizes mechanism-driven patient stratification rather than only clinical endpoint testing.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai Tongji Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Xuebo Liu
• Email: lxb70@hotmail.com
• Phone: 13801926702

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.