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

Acute Myocardial Infarction Clinical Trial

— COLIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363725
• Other study ID #: 9439
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2015
• Last updated: January 16, 2017
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Colchimax®

• Conventional treatment

Locations

Country	Name	City	State
France	University Hospital Arnaud de Villeneuve	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC CRP		5 days
Secondary	Drug tolerance	Clinical outcome	1 year
Secondary	hospitalization time	Clinical outcome	1 year
Secondary	CRP measurement	Intrahospital peak CPK (Biological outcome)	1 year
Secondary	CPK measurement	Size IDM (pic and kinetics) (Biological outcome)	1 year
Secondary	Troponin-hs measurement	Size IDM (pic and kinetics) (Biological outcome)	1 year
Secondary	Creatinine level	Biological outcome	Day of inclusion and one month after inclusion
Secondary	measurement of left ventricular end-systolic volume	Remodeling ETT	Day of inclusion and one month after inclusion
Secondary	measurement of left ventricular diastolic volume	Remodeling ETT	Day of inclusion and one month after inclusion
Secondary	measurement remodeling	Remodeling ETT	One month after inclusion