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Lancet. 2011 Jun 11;377(9782):2013-22. doi: 10.1016/S0140-6736(11)60600-4. Epub 2011 May 25.

Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial.

Collaborators (810)

Abdel Masih ME, Ameriso S, Barboza A, Cirio JJ, Crespo E, Escaray GE, Esnaola MM, Estol C, Ferrari J, Fraiman HD, Garrote M, Gatto E, Giannaula RJ, Gori H, Herrera G, Ioli P, Losano JC, Povedano G, 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, Brücke 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, Fábio 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, Zétola 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 Muñoz A, Lavados Germain P, Lavados Montes M, Prina Pacheco L, Vargas Cañas 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 B, 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 F, 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 MG, Henningsen H, Hetzel A, Hoff mann 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-Lamadé 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, Töpper 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 Castaño 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, Canhão P, Correia C, Cunha L, Grilo Gonçalves J, Machado Cândido J, Salgado AV, Bajenaru O, Bulboaca A, Campeanu A, Lazar T, Marginean I, Minea D, Pascu I, Pereanu M, Perju L, Popescu CD, Simu M, Stefanache F, Toldisan I, Tuta S, Zaharia C, Alifi rova 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 NV, 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 Naranjo I, Castillo Sanchez J, Chamorro Sanchez A, Davalos Errando A, Diaz Marin C, Diez Tejedor E, Egido Herrero JA, Fernandez Bolaños R, Fernandez Fernandez O, Figuerola Roig A, Sclarsky DG, Gil Nuñez A, Gomez Sanchez JC, Gomez CI, Escobar E, 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, López Fernández JC, Maestre Moreno J, Marti-Vilalta JL, Martin Gonzalez R, Masjuan Vallejo J, Medina Rodriguez A, Moltó Jorda JM, Moreno Carretero 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 García J, Trejo Gabriel JM, Vivancos Mora J, Andersson B, Bysell SE, Cederin B, Laska AC, Lindgren A, Petersson J, Wahlgren NG, Wallén 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, Poungvarin N, Suwanwela NC, Tiamkao S, Towanabut 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, 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, Lebedynets V, Maly V, Mischenko T, Moskovko S, Orzheshkovskyy V, Smolanka V, Yavors'ka V, Zozulya I.

Erratum in

  • Lancet. 2011 Jul 30;378(9789):402.

Abstract

BACKGROUND:

Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of recurrent stroke or other cardiovascular events. We compared the selective thromboxane-prostaglandin receptor antagonist terutroban with aspirin in the prevention of cerebral and cardiovascular ischaemic events in patients with a recent non-cardioembolic cerebral ischaemic event.

METHODS:

This randomised, double-blind, parallel-group trial was undertaken in 802 centres in 46 countries. Patients who had an ischaemic stroke in the previous 3 months or a TIA in the previous 8 days were randomly allocated with a central interactive response system to 30 mg per day terutroban or 100 mg per day aspirin. Patients and investigators were masked to treatment allocation. The primary efficacy endpoint was a composite of fatal or non-fatal ischaemic stroke, fatal or non-fatal myocardial infarction, or other vascular death (excluding haemorrhagic death). We planned a sequential statistical analysis of non-inferiority (margin 1·05) followed by analysis of superiority. Analysis was by intention to treat. The study was stopped prematurely for futility on the basis of the recommendation of the Data Monitoring Committee. This study is registered, number ISRCTN66157730.

FINDINGS:

9562 patients were assigned to terutroban (9556 analysed) and 9558 to aspirin (9544 analysed); mean follow-up was 28·3 months (SD 7·7). The primary endpoint occurred in 1091 (11%) patients receiving terutroban and 1062 (11%) receiving aspirin (hazard ratio [HR] 1·02, 95% CI 0·94-1·12). There was no evidence of a difference between terutroban and aspirin for the secondary or tertiary endpoints. We recorded some increase in minor bleedings with terutroban compared with aspirin (1147 [12%] vs 1045 [11%]; HR 1·11, 95% CI 1·02-1·21), but no significant differences in other safety endpoints.

INTERPRETATION:

The trial did not meet the predefined criteria for non-inferiority, but showed similar rates of the primary endpoint with terutroban and aspirin, without safety advantages for terutroban. In a worldwide perspective, aspirin remains the gold standard antiplatelet drug for secondary stroke prevention in view of its efficacy, tolerance, and cost.

FUNDING:

Servier, France.

PMID:
21616527
DOI:
10.1016/S0140-6736(11)60600-4
[Indexed for MEDLINE]

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