NCT02363725

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

January 8, 2015

Last Update Submit

January 16, 2017

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionInflammationCRPColchicine

Outcome Measures

Primary Outcomes (1)

  • AUC CRP

    5 days

Secondary Outcomes (9)

  • Drug tolerance

    1 year

  • hospitalization time

    1 year

  • CRP measurement

    1 year

  • CPK measurement

    1 year

  • Troponin-hs measurement

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Conventionnal treatment

OTHER

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

Conventionnal + Colchimax®

EXPERIMENTAL

Optimal conventional treatment + Colchimax®

Drug: Colchimax®Drug: Conventional treatment

Interventions

Colchimax®DRUG
Conventionnal + Colchimax®
Conventional treatmentDRUG
Conventionnal + Colchimax®Conventionnal treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myocardial inflarction (occlusion of coronary artery as assessed on the coronaro angiogram)
  • Adult (18-90y)
  • Men / women
  • Aigned informed consent
  • Health insurance

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Arnaud de Villeneuve

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Inflammation

Interventions

colchimax

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francois ROUBILLE, MD, PhD

    University Hospital, Montpellier France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

February 16, 2015

Study Start

December 1, 2014

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

FR(1)