Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
Information source: University Hospital, Montpellier
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction
Intervention: Colchimax® (Drug); Conventional treatment (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Hospital, Montpellier Official(s) and/or principal investigator(s):
Francois ROUBILLE, MD, PhD, Principal Investigator, Affiliation: University Hospital Montpellier France
Overall contact:
François ROUBILLE, MD, PhD, Phone: 0033 7 88 01 41 36, Email: francois.roubille@gmail.com
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
Clinical Details
Official title: Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUC CRP
Secondary outcome: Drug tolerancehospitalization time CRP measurement CPK measurement Troponin-hs measurement Creatinine level measurement of left ventricular end-systolic volume measurement of left ventricular diastolic volume measurement remodeling
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
François ROUBILLE, MD, PhD, Phone: 0033 7 88 01 41 36, Email: francois.roubille@gmail.com
University Hospital Arnaud de Villeneuve, Montpellier 34295, France; Recruiting
ROUBILLE François, MD, PhD, Phone: 0033 7 88 01 41 36, Email: francois.roubille@gmail.com
CUNG Dinh Thien Tri, Sub-Investigator
LECLERCQ Florence, Sub-Investigator
LATTUCA Benoit, Sub-Investigator
MACIA Jean-Christophe, Sub-Investigator
CRANSAC Frédéric, Sub-Investigator
CADE Stephane, Sub-Investigator
Additional Information
Starting date: December 2014
Last updated: February 9, 2015
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