The Effect of Colchicine on Inflammation in ACS Patients

Study Overview
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Brief Summary
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This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients

Detailed Description
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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.

Official Title
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The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients

Conditions
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Acute Coronary Syndrome, STEMI

Intervention / Treatment
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* Drug: Colchicine Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine group<br>Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months | Drug: Colchicine Tablets<br>* Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months<br>* Other names: Colchicine;|
| No Intervention: STEMI standard treatment group<br>Control group, STEMI standard treatment only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colchicine, Inflammation, ACS, STEMI, Atherosclerosis