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

January 16, 2017 updated by: University Hospital, Montpellier

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • University Hospital Arnaud de Villeneuve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Conventionnal 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.
Drug: Conventional treatment
Experimental: Conventionnal + Colchimax®
Optimal conventional treatment + Colchimax®
Drug: Conventional treatment
Drug: Colchimax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC CRP
Time Frame: 5 days
5 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Francois ROUBILLE, MD, PhD, University Hospital, Montpellier France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9439

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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