Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
NCT ID: NCT02363725
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2014-12-31
2016-08-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventionnal treatment
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.
Conventional treatment
Conventionnal + Colchimax®
Optimal conventional treatment + Colchimax®
Colchimax®
Conventional treatment
Interventions
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Colchimax®
Conventional treatment
Eligibility Criteria
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Inclusion Criteria
* Adult (18-90y)
* Men / women
* Aigned informed consent
* Health insurance
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Francois ROUBILLE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier France
Locations
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University Hospital Arnaud de Villeneuve
Montpellier, , France
Countries
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Other Identifiers
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9439
Identifier Type: -
Identifier Source: org_study_id
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