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Cerebrovasc Dis. 2009;27(5):509-18. doi: 10.1159/000212671. Epub 2009 Apr 16.

Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: the prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study.

Collaborators (887)

Bousser MG, Amarenco P, Chamorro A, Fisher M, Ford I, Fox K, Hennerici MG, Rothwell P, Julian D, Fieschi G, Fieschi C, Boysen G, Pocock S, Conard J, Orgogozo JM, Inzitari D, Erkinjuntti T, Pasquier F, O'Brien JT, Mas JL, Gueret P, Lenzi GL, Leys D, Lopez-Sendon JL, Norrving B, Ferro J, Thygesen K, Orgogozo JM, Inzitari D, Erkinjuntti T, Pasquier F, O'Brien JT, Cowpply-Bonny P, Ameriso S, Donnan D, Lang W, Thijs V, Fernandes JG, Stamenova P, Teal P, Lavados P, Lu C, Poljakovic Z, Kalita Z, Kaste M, Moulin T, Vemmos K, Diener HC, Wong LK, Nagy Z, Chopra JS, McCormack P, Gensini GF, Budrys V, Droste D, Tan KS, Benomar A, Cantu-Brito C, Barber A, Koudstaal PJ, Thomassen L, Czlonkowska A, Cunha L, Bajenaru O, Yakhno N, Chen C, Lisy L, Zvan B, Bryer A, Kim JS, Vivancos J, Wahlgren NG, Mattle HP, Liu SJ, Poungvarin N, Hentati F, Bahar S, Mischenko T, Lees K, Abdel Masih ME, Ameriso S, Barboza A, Cirio JJ, Crespo E, Escaray GE, Esnaola MM, Rojas, Estol C, Ferrari J, Fraiman HD, Garrote M, Gatto E, Giannaula RJ, Gori H, Herrera G, Ioli P, Losano JC, Povedano, Reich E, Rey RC, Rotta Escalante R, Saredo G, Zurru MC, Anderson C, Bladin C, Crimmins D, Davis S, Donnan G, Dunbabin D, Frayne J, Gates P, Hankey G, Helme R, Herkes G, Karrasch J, Kimber T, Jannes J, Landau P, Levi C, Lueck C, Markus R, Phan T, Schwartz R, Schultz D, Blacker D, Read S, Williams M, Aichner F, Auff E, Bancher C, Binder H, Brainin M, Brucke T, Eggers C, Fertl E, Ladurner G, Lalouschek W, Lang W, Mamoli B, Mitrovic N, Noisternig G, Schmidt R, Vosko M, Willeit J, Zaruba E, Boon P, Bourgeois P, Caekebeke J, Cals N, Cras P, Desfontaines P, De Deyn PP, Dieudonne L, De Klippel N, Laloux P, Maertens de Noordhout A, Merlevede K, Michotte A, Pandolfo M, Peeters A, Peeters D, Tack P, Thijs V, Van Buggenhout E, Van Landegem W, Vanhooren G, Vermylen P, Annes M, Brondani R, De Carvalho JJ, Cendes F, Fabio SR, Fernandes JG, Ferraz AC, De Freitas GR, Gagliardi RJ, Gomes Neto A, Haussen SR, Kowacs PA, Martins SC, Minelli C, Moro CH, Noujaim JE, Rocha MS, Da Silva MT, Silveira JR, Yamamoto F, Zetola VH, Baldaranov D, Deleva N, Haralanov L, Milanov I, Mintchev D, Petrova N, Shotekov P, Stamenov B, Stamenova P, Zahariev Z, Arts R, Bayer N, Beaudry M, Berger L, Bozek C, Collier T, Cote R, Desai H, Durocher A, Hachinski V, Hill M, Hoppe B, Howse D, Mackey A, Maharaj M, Minuk J, Moddel G, Novak D, Penn A, Rabinovitch H, Selchen D, Shuaib A, Silva J, Silver F, Spence D, Stotts G, Tamayo A, Teitelbaum J, Veloso F, Voll C, Winder T, Barrientos Uribe N, Galdames Poblete D, Garcia Figueroa P, Gasic Yaconi K, Jaramillo Munoz A, Lavados Germain P, Lavados Montes M, Nancupil Bello CR, Prina Pacheco L, Vargas Canas A, Venegas Francke P, Chen H, Cheng Y, Cui L, Di Q, Dong Q, Fan D, Feng H, Huang Y, Li J, Li W, Li Z, Lin H, Liu M, Miao L, Ren H, Wang Y, Wu J, Zhang W, Zhao G, Zhao H, Zhou H, Antoncic I, Demarin V, Lusic I, Pavlicek I, Poljakovic Z, Soldo Butkovic S, Bar M, Bauer J, Kalina M, Kalita Z, Kanovsky P, Jura R, Neumann J, Rektor I, Skoda O, Vaclavik D, Eerola A, Hillbom M, Kaste M, Kinnunen E, Koivisto K, Numminen H, Rissanen A, Roine R, Sivenius J, Alamowitch S, Amarenco P, Autret A, Avendano S, Bataillard M, Berthier E, Besson G, Bille-Turc F, Boulliat J, Boulesteix JM, Brosset C, Cesaro P, Albucher JF, Clavelou P, Colamarino R, Crassard I, de Broucker T, de Bray JM, Desbordes P, Diot E, Ducrocq X, Ellie E, Faucheux JM, Giroud M, Godefroy O, Guillon B, Huttin H, Just A, Lamy C, Lejeune P, Lucas C, Macian-Montoro F, Mackowiak A, Maillet Vioud M, Pico F, Milandre L, Milhaud D, Malbec M, Moulin T, Neau JP, Pinel JF, Robin C, Rodier G, Rosolacci T, Rouanet F, Rouhart FF, Sablot D, Servan J, Smadja D, Trouillas P, Valance J, Viader F, Viallet F, Wolff V, Zagnoli F, Zuber M, Angerer M, Becker U, Berlit P, Berrouschot J, Biniek R, Bitsch A, Brodhun R, Dichgans M, Diener HC, Druschky KF, Dux R, Faiss JH, Ferbert A, Gahn G, Grotemeyer KH, Goertler M, Grau A, Griewing B, Grond M, Haan J, Haberl R, Hamann G, Hamer H, Harms L, Heide W, Hennerici M, Henningsen H, Hetzel A, Hoffmann F, Huber R, Isenmann S, Jander S, Joerg J, Kaps M, Kastrup A, Kessler C, Koehler W, Koelmel HW, Lichy C, Luckner K, Malessa R, Mallmann A, Meyding-Lamade U, Molitor H, Mueller-Jensen A, Muellges W, Noth J, Nueckel M, Ochs G, Poppert H, Roether J, Rosenkranz M, Sander D, Schaebitz WR, Schlachetzki F, Schlegel U, Schmid E, Schneider D, Schwarz M, Seidel G, Sieble M, Sliwka U, Stingele R, Stoegbauer F, Szabo K, Topper R, Treib J, Weissenborn K, Widder B, Witte O, Karageorgiou K, Mitsikostas DD, Papadimitriou A, Papathanasopoulos P, Vemmos K, Chan H, Ng P, Tsoi T, Wong LK, Bartos L, Csanyi A, Csiba L, Csornai M, Dioszeghy P, Fazekas A, Harcos P, Horvath S, Kaposzta Z, Kerenyi L, Kincses J, Koves A, Nikl J, Panczel G, Pongracz E, Sebestyen K, Semjen J, Szabo M, Szegedi N, Valikovics A, Varszegi R, Vecsei L, Borah N, Ichaporia N, Kaul S, Meenakshi-Sundaram S, Mehndiratta MM, Misra UK, Murthy JM, Nayak D, Poncha F, Shah A, Singh G, Srinivasa R, Venkateswarlu K, Wadia RS, Collins R, Harbison J, Hickey P, Kelly P, McCormack P, Murphy S, Adami A, Agnelli G, Agostoni E, Anzola GP, Arnaboldi M, Bassi P, Billo G, Bottacchi E, Bovi P, Cappa S, Cappelletti C, Carolei A, Cavallini A, Chiodo Grandi F, Comi G, Consoli D, Corsi FM, Costanzo E, De Falco F, Devetag F, Di Lazzaro V, Di Piero V, Diomedi M, Fattorello Salimbeni C, Federico F, Feleppa M, Ferrarese C, Gandolfo C, Giaccaglini E, Giaquinto S, Giobbe D, Giometto B, Greco G, Guidetti D, Guidotti M, Iudice A, Lembo G, Marengo C, Marini P, Melis M, Micieli G, Musolino R, Mutani R, Neri G, Parati E, Pastore L, Porazzi D, Prati P, Procaccianti G, Rasura M, Rossini PM, Santilli IM, Semplicini A, Silvestrini M, Tanganelli P, Tedeschi G, Tezzon F, Tola MR, Villani A, Zanferrari C, Zarcone D, Bickuviene I, Budrys V, Gumbrevicius G, Obelieniene D, Skaringa AA, Virketiene I, Droste D, Tan KS, Tharakan J, Aleman Pedroza JM, Cantu Brito C, Escamilla Garza JM, Fernandez Vera JA, Leal Cantu R, Leon Flores LI, Lopez Ruiz M, Reyes Gutierrez GA, Reyes Morales S, Rivera Castano L, Rodrigues Leyva I, Ruiz Sandoval JL, Vega Boada F, Belahsen F, Kissani N, Mosseddaq R, Slassi I, Yahyaoui M, Boiten J, Bornebroek M, De Kort PL, De Leeuw HF, Donders RC, Franke CL, Hertzberger LI, Jansen BP, Kappelle LJ, Keizer K, Koudstaal PJ, Kuster JA, Limburg M, Mulleners WM, Pop PH, Van Den Berg JS, Van Gemert HM, Verbiest HB, Weinstein HC, Barber A, Clark M, Fink J, Gommans J, Jayathissa S, Kilfoyle D, Kumar A, Hurtig U, Indredavik B, Kloster R, Salvesen R, Thomassen L, Czlonkowska A, Drozdowski W, Fryze W, Klimek A, Kochanowski J, Kozubski W, Ksiazkiewicz B, Kwiecinski H, Kuczynska-Zardzewialy A, Motta E, Nowacki P, Nyka W, Opala G, Pierzchala K, Pniewski J, Podemski R, Selmaj K, Stelmasiak Z, Stepien A, Strzelecka-Gorzynska M, Szczudlik A, Wajgt A, Wiszniewska M, Wlodek A, Canhao P, Correia C, Cunha L, Grilo Goncalves J, Machado Candido J, Salgado AV, Bajenaru O, Bulboaca A, Campeanu A, Lazar T, Marginean I, Minea D, Pascu I, Pereanu M, Perju-Dumbrava L, Popescu CD, Simu M, Stefanache F, Toldisan I, Tuta S, Zaharia C, Alifirova V, Arkhipov S, Balunov O, Balyazin V, Belkin A, Belova A, Boiko A, Bogdanov E, Butko D, Chukhlovina M, Doronin B, Ermilova E, Evzelman M, Fedin A, Fedorova N, Golikov K, Golovkin V, Gusev E, Gustov A, Jakupov E, Kamchatnov P, Khabirov F, Kirienko A, Klimov I, Klocheva E, Kotov S, Kuznetsov A, Laskov V, Levin Y, Mashkova N, Nazarov A, Novikova L, Odinak M, Parfenov V, Pilipenko P, Pokrovsky A, Poverennova I, Rodoman G, Roshkovskaya L, Shirokov E, Shmyriov V, Sholomov I, Skoromets A, Skvortsova V, Spirin N, Stakhovskaya L, Sharov M, Sherman M, Shutov A, Strachunskaya E, Stulin I, Suslina Z, Volosevitch A, Vorobiev P, Vorobyeva O, Voronkova L, Voskresenskaya O, Zhuliov N, Chan B, Chang HM, Venketasubramanian N, Brozman M, Dvorak M, Dzugan J, Garay R, Gdovinova Z, Gurcik L, Krastev G, Kukumberg P, Kurca E, Lisy L, Meluch S, Nyeky M, Turcani P, Vyletelka J, Klanjscek G, Zujovic E, Zupan M, Zvan B, Bester FC, Carr J, Coetzee C, Frost AC, Gardiner J, Giampaolo DL, Kesler S, Lurie DM, Retief CF, Roos JS, Bae HJ, Cha JK, Cho KH, Heo JH, Kim EG, Kim JS, Lee BC, Lee KH, Lee J, Rha JH, Yoon BW, Alvarez Sabin J, Arboix Damunt A, De Arce Borda A, Asensi Alvarez JM, Bermejo Pareja F, Botia Paniagua E, Casado I, Naranjo I, Castillo Sanchez J, Chamorro Sanchez A, Davalos Errando A, Diaz Marin C, Diez Tejedor E, Egido Herrero JA, Fernandez Bolanos R, Fernandez Fernandez O, Figuerola Roig A, Geffner Sclarsky D, Gil Nunez A, Gomez Sanchez JC, Gomez-Escalonilla Escobar CI, Gonzalez Masegosa A, Gonzalez Menacho J, Gracia Fleta F, Izquierdo Ayuso G, Jimenez Hernandez D, Jimenez Martinez C, Lago Martin A, Lainez Andres JM, Larracoechea Jausoro J, Lopez Fernandez JC, Maestre Moreno J, Marti-Vilalta JL, Martin Gonzalez R, Masjuan Vallejo J, Medina Rodriguez A, Molto Jorda JM, Moreno Carre tero MJ, Moris de le Tassa G, Morlan Gracia L, Mostacero Miguez E, Osuna Pulido T, Pareja Martinez A, Pinedo Brochado A, Pons Amate JM, Rodriguez Alvarez JR, Roquer Gonzalez J, Sanahuja Montesinos J, Sanchez Sanchez MC, Segura Martin T, Serena Leal J, Tejada Garcia J, Trejo Gabriel JM, Vivancos Mora J, Andersson B, Bysell SE, Cederin B, Laska AC, Lindgren A, Petersson TJ, Wahlgren NG, Wallen T, Baumgartner R, Beer HJ, Hirt L, Hungerbuehler H, Lyrer P, Mattle HP, Michel P, Mueller F, Tettenborn B, Chang KC, Jeng JS, Lien LM, Lin RT, Liu CH, Liu SJ, Po H, Wu SL, Chankrachang S, Laptikultham S, Nidhinandana S, Pongpakdee S, Benammou S, Frih Ayed M, Gouider R, Hentati F, Mhiri C, M'rabet A, Mrissa R, Bahar S, Balkan S, Can U, Dalkara T, Kirbas D, Kumral E, Ozdemir G, Ozeren A, Ozmenoglu M, Ozturk S, Lebedynets V, Maly V, Mischenko T, Moskovko S, Orzheshkovskyy V, Smolanka V, Yavors'ka V, Zozulya I, Bamford J, Barber M, Barer D, Baron JC, Bath P, Broughton D, Brown M, Chataway J, Curless R, Darawil K, Datta P, Dennis M, Durairaj R, Egbuji J, Ellis S, Ford G, Freeman A, Fulcher R, Gray C, Harrington F, Hudson C, Iveson E, James M, Jenkinson D, Kalra L, Kelly D, Krishnamoorthy S, Langhorne P, Lees K, Magorrian M, MacLeod M, MacLeod MJ, MacWalter R, Markus H, Muhiddin K, Muir K, Murphy P, Power M, Price C, Rashed K, Robinson T, Rudd A, Sanmuganathan P, Sharma J, Shaw L, Shetty H, Smithard D, Tyrrell P, Vahidassr MD, Venables G, Watt M, White R.

Erratum in

Abstract

BACKGROUND:

Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic Attack (PERFORM) Study, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events.

METHODS AND RESULTS:

The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged > or =55 years, having suffered an ischemic stroke (< or =3 months) or a transient ischemic attack (< or =8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2-4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006.

CONCLUSIONS:

The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event.

PMID:
19372653
DOI:
10.1159/000212671
[Indexed for MEDLINE]

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