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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Colchimax®
Conventional treatment
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Inflammation, CRP, Colchicine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Arnaud de Villeneuve

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Conventionnal treatment

Conventionnal + Colchimax®

Arm Description

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.

Optimal conventional treatment + Colchimax®

Outcomes

Primary Outcome Measures

AUC CRP

Secondary Outcome Measures

Drug tolerance
Clinical outcome
hospitalization time
Clinical outcome
CRP measurement
Intrahospital peak CPK (Biological outcome)
CPK measurement
Size IDM (pic and kinetics) (Biological outcome)
Troponin-hs measurement
Size IDM (pic and kinetics) (Biological outcome)
Creatinine level
Biological outcome
measurement of left ventricular end-systolic volume
Remodeling ETT
measurement of left ventricular diastolic volume
Remodeling ETT
measurement remodeling
Remodeling ETT

Full Information

First Posted
January 8, 2015
Last Updated
January 16, 2017
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02363725
Brief Title
Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
Acronym
COLIN
Official Title
Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Inflammation, CRP, Colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventionnal treatment
Arm Type
Other
Arm Description
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.
Arm Title
Conventionnal + Colchimax®
Arm Type
Experimental
Arm Description
Optimal conventional treatment + Colchimax®
Intervention Type
Drug
Intervention Name(s)
Colchimax®
Intervention Type
Drug
Intervention Name(s)
Conventional treatment
Primary Outcome Measure Information:
Title
AUC CRP
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Drug tolerance
Description
Clinical outcome
Time Frame
1 year
Title
hospitalization time
Description
Clinical outcome
Time Frame
1 year
Title
CRP measurement
Description
Intrahospital peak CPK (Biological outcome)
Time Frame
1 year
Title
CPK measurement
Description
Size IDM (pic and kinetics) (Biological outcome)
Time Frame
1 year
Title
Troponin-hs measurement
Description
Size IDM (pic and kinetics) (Biological outcome)
Time Frame
1 year
Title
Creatinine level
Description
Biological outcome
Time Frame
Day of inclusion and one month after inclusion
Title
measurement of left ventricular end-systolic volume
Description
Remodeling ETT
Time Frame
Day of inclusion and one month after inclusion
Title
measurement of left ventricular diastolic volume
Description
Remodeling ETT
Time Frame
Day of inclusion and one month after inclusion
Title
measurement remodeling
Description
Remodeling ETT
Time Frame
One month after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois ROUBILLE, MD, PhD
Organizational Affiliation
University Hospital, Montpellier France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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