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

Launched by SHANGHAI TONGJI HOSPITAL, TONGJI UNIVERSITY SCHOOL OF MEDICINE · Jul 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a medicine called colchicine works to reduce inflammation in people who have acute coronary syndrome (ACS), a condition that includes serious heart problems like heart attacks. The researchers want to understand exactly how colchicine helps and to develop a way to predict which patients will benefit the most from this treatment. To do this, they will look at detailed biological information from patients before and after treatment.

People who might join the study are adults between 18 and 80 years old who have recently been diagnosed with ACS and are receiving standard heart treatment. Participants must be able to give their permission to join and should not have certain health issues, such as severe liver or kidney problems, ongoing infections, or allergies to colchicine. Women who are pregnant, breastfeeding, or not using effective birth control are also excluded. If you join, you can expect to receive colchicine alongside your usual heart medications, and the doctors will collect samples and information to learn more about how the medicine works in your body. This study is currently recruiting patients and aims to help doctors better tailor treatments for heart patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Between the ages of 18 and 80 2. ACS (STEMI or NSTE-ACS) 3. Patients to receive standardised drug therapy 4. able and willing to provide informed consent
• Exclusion Criteria:
• • - 1. any contraindication to colchicine or known intolerance to colchicine 2. has been using colchicine for a prolonged period of time for other medical conditions 3. women of childbearing age who are pregnant, breastfeeding or not using effective contraception 4. coronary artery bypass grafting within the last 3 years or planned 5. 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; 6. severe renal impairment: eGFR \<30mL/min/1.73m2 7. thrombocytopenia (platelet count less than 100\*10⁹/L) 8. active diarrhoea 9. Infectious diseases: presence of uncontrollable infectious diseases 10. immune-related diseases: known immune diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumours, etc.
• • 11. 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 12. planning to use systemic anti-inflammatory therapies such as NSAIDs, hormones, immunomodulators and chemotherapeutic agents