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

University Hospital Center (CHU)

Status and phase: Completed; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Drug: Colchimax®; Drug: Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02363725

9439

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Conventionnal treatment

Other group

Description:

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.

Treatment:

Drug: Conventional treatment

Conventionnal + Colchimax®

Experimental group

Description:

Optimal conventional treatment + Colchimax®

Treatment:

Drug: Conventional treatment

Drug: Colchimax®