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

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

This project will try to see if daily low-dose colchicine reduces inflammation and to find biological markers that predict who benefits among people with acute coronary syndrome.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07064109 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–80 with acute coronary syndrome (STEMI or NSTE-ACS) who can receive standardised drug therapy, are able to provide informed consent, and have no contraindication to colchicine.

Not a fit: People already on long-term colchicine, those with contraindications such as severe hepatic or renal impairment, thrombocytopenia, active uncontrollable infection, certain immune diseases, pregnant or breastfeeding women, or those unable to attend the Shanghai site are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could help doctors target colchicine to the ACS patients most likely to benefit, potentially reducing recurrent heart events and avoiding unnecessary side effects.

How similar studies have performed: Large randomized trials (for example COLCOT and LoDoCo2) have shown colchicine can reduce cardiovascular events in coronary disease, but using multi-omics to predict individual response is a novel approach.

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

Where this trial is running

Shanghai

• Shanghai Tongji Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xuebo Liu

Conditions ACS - Acute Coronary Syndrome; ACS; colchicine