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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Colchicine

Criteria

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