NCT07064109Recruiting
Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients
Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in Acute Coronary Syndromes Patients
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 3 Jul 2025
- Start date
- Jul 2025
- Primary completion date
- Jul 2027
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Diseases
- Coronary artery disease
- NCT number
- NCT07064109
What you commit to
- Study type: Interventional
- Planned participants: 380
- From Jul 2025 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Has been using colchicine for a prolonged period of time for other medical conditions
- 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.
Lab values
- 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)
Age
- Women of childbearing age who are pregnant, breastfeeding or not using effective contraception
Other
- Any contraindication to colchicine or known intolerance to colchicine
- Coronary artery bypass grafting within the last 3 years or planned
- Active diarrhoea
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tongji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.