Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response

Study Overview
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Brief Summary
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Background: Colchicine is an old well-known venerable drug routinely used in gout attacks for instance. More recnetly it is regularly use in the treatment of pericarditis. It couls exert antiiflammatory effects targeting the adverse inflammation occuring incase of acute myocardial infarction, which is involved in poor outcomes or longer stay at hospital. Endpoints: Main endpoint: AUC CRP during the initial hospital stay Secondary endpoints: Clinical: oucomes Imaging: ETT, MRI Biological: various biomarkers Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal optimal treatment versus conventionnal optimal treatment + colchicine

Official Title
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Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Colchimax®
* Drug: Conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute myocardial inflarction (occlusion of coronary artery as assessed on the coronaro angiogram) Adult (18-90y) Men / women Aigned informed consent Health insurance Exclusion Criteria: Cardiogenic shock Digestive troubles Active bowels inflammatory disease (Crhon, chronic, diarrhea...) Intolerance to the drug Renal insufficiency clearance < 30mL/min Immunosuppression, aplasia Active infectious disease, active known neoplasia, chronic inflammatory disease Hypersensitivity, allergy to one of studies components Active liver disease Poor hemodynamic conditions Recent severe sepsis Chronic treatment with corticoids or no steroids antiinflammatory agents No possibility for informed consent Protected by the law Poor abservance History of toxicomania, suicice attempts Pregnacy, breeding, project of pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventionnal treatment<br>Optimal conventional treatment used for patients admitted for STEMI (ESC guidelines 2012): Double anti-aggregation IEC (or sartan) at best tolerated dose Beta-blocker at best tolerated dose High dose statin (usually atorvastatin 80 mg daily) If ventricular dysfunction; inhibitor minérolcorticoïdes (the eplerenone more often) Any other treatment will be logged. | Drug: Conventional treatment<br> <br> |
| Experimental: Conventionnal + Colchimax®<br>Optimal conventional treatment + Colchimax® | Drug: Colchimax®<br> <br> Drug: Conventional treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC CRP |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug tolerance | Clinical outcome | 1 year | 
| hospitalization time | Clinical outcome | 1 year | 
| CRP measurement | Intrahospital peak CPK (Biological outcome) | 1 year | 
| CPK measurement | Size IDM (pic and kinetics) (Biological outcome) | 1 year | 
| Troponin-hs measurement | Size IDM (pic and kinetics) (Biological outcome) | 1 year | 
| Creatinine level | Biological outcome | Day of inclusion and one month after inclusion | 
| measurement of left ventricular end-systolic volume | Remodeling ETT | Day of inclusion and one month after inclusion | 
| measurement of left ventricular diastolic volume | Remodeling ETT | Day of inclusion and one month after inclusion | 
| measurement remodeling | Remodeling ETT | One month after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRP, Inflammation, Acute myocardial infarction, Colchicine