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

Information source: University Hospital, Montpellier
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myocardial Infarction

Intervention: Colchimax® (Drug); Conventional treatment (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital, Montpellier

Official(s) and/or principal investigator(s):
Francois ROUBILLE, MD, PhD, Principal Investigator, Affiliation: University Hospital Montpellier France

Overall contact:
François ROUBILLE, MD, PhD, Phone: 0033 7 88 01 41 36, Email: francois.roubille@gmail.com

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

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: AUC CRP

Secondary outcome:

Drug tolerance

hospitalization time

CRP measurement

CPK measurement

Troponin-hs measurement

Creatinine level

measurement of left ventricular end-systolic volume

measurement of left ventricular diastolic volume

measurement remodeling

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Locations and Contacts

François ROUBILLE, MD, PhD, Phone: 0033 7 88 01 41 36, Email: francois.roubille@gmail.com

University Hospital Arnaud de Villeneuve, Montpellier 34295, France; Recruiting
ROUBILLE François, MD, PhD, Phone: 0033 7 88 01 41 36, Email: francois.roubille@gmail.com
CUNG Dinh Thien Tri, Sub-Investigator
LECLERCQ Florence, Sub-Investigator
LATTUCA Benoit, Sub-Investigator
MACIA Jean-Christophe, Sub-Investigator
CRANSAC Frédéric, Sub-Investigator
CADE Stephane, Sub-Investigator
Additional Information

Starting date: December 2014
Last updated: February 9, 2015

Page last updated: August 23, 2015

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