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OpenTrials
Completed

NCT Number: NCT02363725

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

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

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Key information

Conditions

Acute Myocardial Infarction Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Arnaud de Villeneuve

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchimax®

Drug

Conventional Treatment

Drug

Primary outcomes

  1. AUC CRP

    Time frame: 5 days

Secondary outcomes

  1. Drug tolerance

    Time frame: 1 year

    Clinical outcome

  2. hospitalization time

    Time frame: 1 year

    Clinical outcome

  3. CRP measurement

    Time frame: 1 year

    Intrahospital peak CPK (Biological outcome)

  4. CPK measurement

    Time frame: 1 year

    Size IDM (pic and kinetics) (Biological outcome)

  5. Troponin-hs measurement

    Time frame: 1 year

    Size IDM (pic and kinetics) (Biological outcome)

  6. Creatinine level

    Time frame: Day of inclusion and one month after inclusion

    Biological outcome

  7. measurement of left ventricular end-systolic volume

    Time frame: Day of inclusion and one month after inclusion

    Remodeling ETT

  8. measurement of left ventricular diastolic volume

    Time frame: Day of inclusion and one month after inclusion

    Remodeling ETT

  9. measurement remodeling

    Time frame: One month after inclusion

    Remodeling ETT

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: COLIN

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 16, 2015
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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