BridgeMD
Tests treatment safety and results for ACS - Acute Coronary Syndrome
Official title Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients
ClinicalTrials.gov ID: NCT07064109
What this study is testing
What is Colchicine 0.5 MG Oral Tablet Once Daily?
Colchicine 0.5 MG Oral Tablet Once Daily is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acs - acute coronary syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- Severe renal impairment: eGFR \<30mL/min/1.73m2
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.