Acute Coronary Syndrome, STEMI
Conditions
Keywords
Colchicine, Inflammation, ACS, STEMI, Atherosclerosis
Brief summary
This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients
Detailed description
This study will evaluate the effect of colchicine on inflammation, cardiac remodeling, and atherosclerotic risk in STEMI patients through the assessment of the IL-1β, sST2, and lipid profile parameters as well as to examine the drug safety and tolerability in these patients.
Interventions
Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Electrocardiography parameters assessors and clinical laboratory technicians were masked to the study patient group allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female * \>18 yrs * STEMI patients who were successfully treated with PCI.
Exclusion criteria
* Pregnant or breast-feeding women or women of childbearing potential. * Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents. * Known hypersensitivity to colchicine or current chronic treatment with colchicine. * Severe renal failure (estimated creatinine clearance \<30ml/min) or hepatic failure (Child Pugh score B or C ) * Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction. * Patients using the following agents: Strong CYP3A4 inhibitors (ritonavir, clarithromycin, ketoconazole, voriconazole, itraconazole), intermediate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, verapamil), P-gp inhibitor (amiodarone, clarithromycin, erythromycin, azithromycin, ranolazine, verapamil, ketoconazole, itraconazole) and grape fruit juice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of colchicine therapy on sST2 levels in ACS patients | 3 months | sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of colchicine therapy on occurrence of ischemic events in ACS patients | 3 months | Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period |
| Change in left ventricular ejection fraction | 3 months | Effect of colchicine therapy on left ventricular ejection fraction percentage (%) |
| Change in serum levels of IL-1beta | 3 months | Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L |
| Lipid profile parameters and TG/HDL-C ratio | 3 months | Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio |
Countries
Egypt
Outcome results
None listed