Document Detail

Rationale and Design of the 'MITOCARE' Study: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of TRO40303 for the Reduction of Reperfusion Injury in Patients Undergoing Percutaneous Coronary Intervention for Acute Myocardial Infarction.
MedLine Citation:
PMID:  23202613     Owner:  NLM     Status:  Publisher    
Treatment of acute ST-elevation myocardial infarction (STEMI) by reperfusion using percutaneous coronary intervention (PCI) or thrombolysis has provided clinical benefits; however, it also induces considerable cell death. This process is called reperfusion injury. The continuing high rates of mortality and heart failure after acute myocardial infarction (AMI) emphasize the need for improved strategies to limit reperfusion injury and improve clinical outcomes. The objective of this study is to assess safety and efficacy of TRO40303 in limiting reperfusion injury in patients treated for STEMI. TRO40303 targets the mitochondrial permeability transition pore, a promising target for the prevention of reperfusion injury. This multicenter, double-blind study will randomize patients with STEMI to TRO40303 or placebo administered just before balloon inflation or thromboaspiration during PCI. The primary outcome measure will be reduction in infarct size (assessed as plasma creatine kinase and troponin I area under the curve over 3 days). The main secondary endpoint will be infarct size normalized to the myocardium at risk (expressed by the myocardial salvage index assessed by cardiac magnetic resonance). The study is being financed under an EU-FP7 grant and conducted under the auspices of the MITOCARE research consortium, which includes experts from clinical and basic research centers, as well as commercial enterprises, throughout Europe. Results from this study will contribute to a better understanding of the complex pathophysiology underlying myocardial injury after STEMI. The present paper describes the rationale, design and the methods of the trial.
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-15
Journal Detail:
Title:  Cardiology     Volume:  123     ISSN:  1421-9751     ISO Abbreviation:  Cardiology     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-12-3     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  1266406     Medline TA:  Cardiology     Country:  -    
Other Details:
Languages:  ENG     Pagination:  201-207     Citation Subset:  -    
Copyright Information:
Copyright © 2012 S. Karger AG, Basel.
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MeSH Terms
Dan Atar / ; Jean-Louis Abitbol / ; Hakan Arheden / ; Alain Berdeaux / ; Jean-Louis Bonnet / ; Marcus Carlsson / ; Peter Clemmensen / ; Valérie Cuvier / ; Jean-Luc Dubois-Randé / ; Henrik Engblom / ; David Erlinge / ; Hüseyin Firat / ; Svend Eggert Jensen / ; Sigrun Halvorsen / ; Henrik Steen Hansen / ; Einar Heiberg / ; Alf-Inge Larsen / ; Philippe Le Corvoisier / ; Pascal Longlade / ; Jan Erik Nordrehaug / ; Carole Perez / ; Rebecca Pruss / ; Gilles Sonou / ; Sophie Schaller / ; Vegard Tuseth / ; Eric Vicaut /

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