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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
1 Hôpital Cardiovasculaire Louis Pradel
2 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
3 LBP - Laboratoire de Biophotonique et Pharmacologie - UMR 7213
4 Les Hôpitaux Universitaires de Strasbourg (HUS)
5 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
6 Cellules Dendritiques, Immunomodulation et Greffes
7 Hôpital Guillaume et René Laennec
8 Service de cardiologie [Toulouse]
9 Centre hospitalier de Pau
10 Department of Cardiology
11 Cardio - BORDEAUX - Department of Cardiology
12 Radiopharmaceutiques biocliniques
13 Centre Hôspitalier Henri Duffaut
14 Hôpital Saint Joseph Saint Luc
15 Centre Hospitalier du Pays d'Aix
16 CHU - CHU Gabriel Montpied
17 Service de cardiologie [CHU Rouen]
18 Clinique Lafourcade [Bayonne]
19 Hôpital Bichat - Claude Bernard
20 LNC - Lipides - Nutrition - Cancer (U866)
21 CHU Dijon
22 Centre Hospitalier Général
23 Centre Hospitalier Compiègne-Noyon
24 Hospital St-Jan Bruges
25 Service de Cardiologie
26 PMRM - Laboratoire de Protection et Remodelage du Myocarde
27 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
28 CH E.Muller Mulhouse - Centre Hospitalier Emile Muller [Mulhouse]
29 Service de Cardiologie
30 CHU Henri Mondor
31 Polyclinique Les Fleurs
32 ORPHY (EA 4324) - Optimisation des régulations physiologiques
33 IGF - Institut de Génomique Fonctionnelle
34 Clinique Esquirol St Hilaire
35 Hôpital Privé Jacques Cartier [Massy]
36 Clinique du Diaconat
37 Grand Hopital de Charleroi
38 Centre Hospitalier Privé Claude Galien - Ramsay Santé
39 LTSI - Laboratoire Traitement du Signal et de l'Image
40 Polyclinique de l'Ormeau
41 Pôle Cardiologie Interventionnelle / Coro-scanner / IRM Cardiaque
42 CHU Caen
43 Clinique de la Sauvegarde [Lyon]
44 Clinique du Tonkin
45 CHRU Lille - Centre Hospitalier Régional Universitaire [Lille]
46 Lund University [Lund]
47 Scandinavian Development Services AB
48 Universiteit Antwerpen [Antwerpen]
49 Vall d'Hebron University Hospital [Barcelona]
50 Cardioprotection
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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CNRS | UNIV-BOURGOGNE | UNIV-ANGERS | UNIV-BREST | UNIV-RENNES1 | HCL | UNAM | LTSI | UGA | LNC-UMR866 | BS | UNIV-MONTPELLIER | UNIV-LYON1 | ENSBANA | AGROSUP-DIJON | UNIV-TOURS | SITE-ALSACE | UNIV-RENNES | COMUE-NORMANDIE | UNIROUEN | ORPHY | IBSAM | UDL | POLITIQUES-PUBLIQUES

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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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