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

Dan Atar*, Jean Louis Abitbol, Hakan Arheden, Alain Berdeaux, Jean Louis Bonnet, Marcus Carlsson, Peter Clemmensen, Valérie Cuvier, Nicolas Danchin, Jean Luc Dubois-Randé, Henrik Engblom, David Erlinge, Hü Seyin Firat, Svend Eggert Jensen, Sigrun Halvorsen, Henrik Steen Hansen, Einar Heiberg, Alf Inge Larsen, Philippe Le Corvoisier, Pascal LongladeJan Erik Nordrehaug, Carole Perez, Rebecca Pruss, Gilles Sonou, Sophie Schaller, Vegard Tuseth, Eric Vicaut

*Corresponding author af dette arbejde

    Publikation: Bidrag til tidsskriftArtikelForskningpeer review

    Abstract

    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.

    OriginalsprogEngelsk
    Sider (fra-til)201-207
    Antal sider7
    TidsskriftCardiology (Switzerland)
    Vol/bind123
    Udgave nummer4
    DOI
    StatusUdgivet - 1 jan. 2013

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