Clinical Trials in China / NCT07064109
Recruiting
Not applicable
Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients
NCT07064109 · tracked via the Priya Life Science China tracker
Condition(s) studied
ACS - Acute Coronary Syndrome
Investigational drug(s) / intervention(s)
Colchicine 0.5 MG Oral Tablet Once Daily: Colchicine 0.5 MG Oral Tablet Once Daily
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Number of responder — 6 months after enrolment
1. Resolution of Inflammation: A reduction in high-sensitivity C-reactive protein (hs-CRP) levels to \<2.0 mg/L, or a decrease of ≥50% from baseline. 2. Clinical Stability: No occurrence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or urgent revascularization. 3. Ventricular Remodeling: This is assessed by parameters such as ventricular volume, wall thickness, left ventricular mass, and LVEF (Left Ventricular Ejection Fraction), measured by cardiac magnetic resonance (CMR) or echocardiography. - Number of Participants with Advances in Coronary Artery Physiology and Function — 1 year after enrolment
Comparing the change in coronary QFR at baseline and one-year follow-up, the sum of QFR of the three major coronary vessels (anterior descending, circumflex, and right coronary artery) was calculated (3V-QFR), and progression in coronary physiology was defined when 3V-QFR minus baseline 3V-QFR at follow-up was ≤ -0.05
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Tongji Hospital | Shanghai | China | Recruiting |
More Shanghai Tongji Hospital, Tongji University School of Medicine trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07064109 on ClinicalTrials.gov ↗ ← All trials in China