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

Phase 2

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Conventional treatment; Drug: Colchimax®

• Registration Number: NCT02363725
• Lead Sponsor: University Hospital, Montpellier

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-16
• Primary Completion: 2016-05
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventionnal treatment	Conventional 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.
Conventionnal + Colchimax®	Colchimax®	Optimal conventional treatment + Colchimax®
Conventionnal + Colchimax®	Conventional treatment	Optimal conventional treatment + Colchimax®

Primary Outcome Measures

Name	Time	Method
AUC CRP	5 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Arnaud de Villeneuve; 🇫🇷 Montpellier, France