Clinical trial NCT02363725: Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
Official title: Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Inflammation
CRP
Colchicine
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: AUC CRP
timeFrame: 5 days
Secondary outcomes:
measure: Drug tolerance
timeFrame: 1 year
measure: hospitalization time
timeFrame: 1 year
measure: CRP measurement
timeFrame: 1 year
measure: CPK measurement
timeFrame: 1 year
measure: Troponin-hs measurement
timeFrame: 1 year
measure: Creatinine level
timeFrame: Day of inclusion and one month after inclusion
measure: measurement of left ventricular end-systolic volume
timeFrame: Day of inclusion and one month after inclusion
measure: measurement of left ventricular diastolic volume
timeFrame: Day of inclusion and one month after inclusion
measure: measurement remodeling
timeFrame: One month after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Arnaud de Villeneuve
Study officials:
affiliation: University Hospital, Montpellier France
name: Francois ROUBILLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: