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This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine group | Experimental | Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months |
|
| STEMI standard treatment group | No Intervention | Control group, STEMI standard treatment only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine Tablets | Drug | Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of colchicine therapy on sST2 levels in ACS patients | sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of colchicine therapy on occurrence of ischemic events in ACS patients | Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period | 3 months |
| Change in left ventricular ejection fraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marwa A Ahmed, Phd | Faculty of Pharmacy, Ain Shams University | Study Director |
| Lamia El Wakeel, Phd | Faculty of Pharmacy, Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39359014 | Derived | Hassanain HA, El Wakeel LM, Khorshid H, Ahmed MA. Colchicine effect on biomarkers of cardiac remodelling and atherosclerosis in ST-elevation myocardial infarction: A randomized controlled trial. Br J Clin Pharmacol. 2025 Feb;91(2):427-438. doi: 10.1111/bcp.16270. Epub 2024 Oct 2. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| D007249 | Inflammation |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Electrocardiography parameters assessors and clinical laboratory technicians were masked to the study patient group allocation
Effect of colchicine therapy on left ventricular ejection fraction percentage (%)
| 3 months |
| Change in serum levels of IL-1beta | Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L | 3 months |
| Lipid profile parameters and TG/HDL-C ratio | Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio | 3 months |
| D009203 |
| Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |