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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:
Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal optimal treatment versus conventionnal optimal treatment + colchicine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventionnal treatment | Other | Optimal conventional treatment used for patients admitted for STEMI (ESC guidelines 2012):
|
|
| Conventionnal + Colchimax® | Experimental | Optimal conventional treatment + Colchimax® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchimax® | Drug |
| ||
| Conventional treatment |
| Measure | Description | Time Frame |
|---|---|---|
| AUC CRP | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Drug tolerance | Clinical outcome | 1 year |
| hospitalization time | Clinical outcome | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois ROUBILLE, MD, PhD | University Hospital, Montpellier France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Arnaud de Villeneuve | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C115752 | colchimax |
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|
| 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 |