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Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial)

Nathan Mewton 1 Thien T. Cung 2 Olivier Morel 3, 4 Guillaume Cayla 5 Eric Bonnefoy-Cudraz 1 Gilles Rioufol 1 Denis Angoulvant 6 Patrice Guerin 7 Meyer Elbaz 8 Nicolas Delarche 9 Pierre Coste 10, 11 Gérald Vanzetto 12 Marc Metge 13 Jean-François Aupetit 14 Bernard Jouve 15 Pascal Motreff 16 Christophe Tron 17 Jean-Noël Labeque 18 Pierre G. Steg 19 Yves Cottin 20, 21 Grégoire Range 22 Jerome Clerc 23 Patrick Coussement 24 Fabrice Prunier 25, 26 Frederique Moulin 27 Olivier Roth 28 Loic Belle 29 Phillipe Dubois 30 Paul Barragan 31 Martine Gilard 32 Christophe Piot 33 Patrice Colin 34 Marie-Claude Morice 35 Jean-Pierre Monassier 36 Omar Ider 36 Jean Luc P. Dubois-Randé 37 Thierry Unterseeh 38 Hervé Lebreton 39 Thierry Beard 40 Didier Blanchard 41 Gilles Grollier 42 Vincent Malquarti 43 Patrick Staat 44 Arnaud Sudre 45 Magnus J. Hansson 46 Eskil Elmer 46 Inesse Boussaha 1 Claire Jossan 1 Anna Torner 47 Marc Claeys 48 David Garcia-Dorado 49 Michel Ovize 50, *
* Corresponding author
Abstract : BACKGROUND: Both acute myocardial ischemia and reperfusion contribute to cardiomyocyte death in ST-elevation myocardial infarction (STEMI). The final infarct size is the principal determinant of subsequent clinical outcome in STEMI patients. In a proof-of-concept phase II trial, the administration of cyclosporine prior to primary percutaneous coronary intervention (PPCI) has been associated with a reduction of infarct size in STEMI patients. METHODS: CIRCUS is an international, prospective, multicenter, randomized, double-blinded, placebo-controlled trial. The study is designed to compare the efficacy and safety of cyclosporine versus placebo, in addition to revascularization by PPCI, in patients presenting with acute anterior myocardial infarction within 12 hours of symptoms onset and initial TIMI flow ≤1 in the culprit left anterior descending coronary artery. Patients are randomized in a 1:1 fashion to 2.5 mg/kg intravenous infusion of cyclosporine or matching placebo performed in the minutes preceding PCI. The primary efficacy end point of CIRCUS is a composite of 1-year all-cause mortality, rehospitalization for heart failure or heart failure worsening during initial hospitalization, and left ventricular adverse remodeling as determined by sequential transthoracic echochardiography. Secondary outcomes will be tested using a hierarchical sequence of left ventricular (LV) ejection fraction and absolute measurements of LV volumes. The composite of death and rehospitalization for heart failure or heart failure worsening during initial hospitalization will be further assessed at three years after the initial infarction. RESULTS: Recruitment lasted from April 2011 to February 2014. The CIRCUS trial has recruited 975 patients with acute anterior myocardial infarction. The 12-months results are expected to be available in 2015. CONCLUSIONS: The CIRCUS trial is testing the hypothesis that cyclosporine in addition to early revascularization with PPCI compared to placebo in patients with acute anterior myocardial infarction reduces the incidence of death, heart failure and adverse LV remodeling at one-year follow-up
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Nathan Mewton, Thien T. Cung, Olivier Morel, Guillaume Cayla, Eric Bonnefoy-Cudraz, et al.. Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial). American Heart Journal, Elsevier, 2015, 169 (6), pp.758--766.e6. ⟨10.1016/j.ahj.2015.02.020⟩. ⟨hal-01260554⟩

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