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N Engl J Med. 2012 Jan 5;366(1):20-33. doi: 10.1056/NEJMoa1109719. Epub 2011 Nov 13.

Thrombin-receptor antagonist vorapaxar in acute coronary syndromes.

Collaborators (980)

Harrington RA, Armstrong PW, Aylward PE, Mahaffey KW, Moliterno DJ, Strony J, Van de Werf F, Wallentin L, White HD, Diaz R, Aylward PE, Huber K, Sinnaeve PR, Nicolau JC, Armstrong PW, Prieto JC, Huo Y, Lixin J, Isaza D, Widimsky P, Grande P, Laine M, Montalescot G, Bode C, Wong L, Ofner P, Lewis BS, Ambrosio G, Valgimigli M, Yamaguchi T, Ogawa H, Park SJ, Cornel JH, Jukema JW, White HD, Nordrehaug JE, Ruzyllo W, Providencia L, Cheem TH, Dalby A, Cequier A, Betriu A, Held C, Wallentin L, Pfisterer M, Chen MF, Erkan A, Storey RF, Chen E, Harrington RA, Hudson MP, Lincoff AM, Mahaffey KW, Moliterno DJ, Strony J, Tricoci P, Whellan DJ, Verheugt F, Frye RL, Hochman J, Steg PG, Bailey KR, Easton JD, Tricoci P, Mahaffey KW, Leonardi S, Chen E, Strony J, Armstrong PW, Lincoff A, Hudson MP, Whellan DJ, Aylward PE, White HD, Van de Werf F, Sinnaeve PR, Rorick TL, Underwood FD, Wrestler J, Larson D, VanDyne B, Kilian A, Harmelin-Kadouri R, Layton L, Lipka L, Petrauskas S, Qidwai M, Sorochuck C, Temple T, Mason D, Sydlowski D, Gallagher B, Villasin A, Beernaert A, Douglas S, Garrett J, Wiering J, Leonardi S, Tricoci P, Sinnaeve PR, Adriaenssens T, Ganame J, Hulselmans M, Katz JN, Kayaert P, La Gerche A, Mahaffey KW, Onsea K, Zalewski J, Johnson A, O'Briant J, Smith M, Akerblom A, Armaganijan L, Bertolami A, Brennan M, da Ponte Nacif SA, de Campos Gonzaga C, deQuadros A, Déry JP, Dev S, Ducrocq G, Eapen ZP, Echenique L, Eggers K, Garcia H, Guimaraes HP, Hagstrom E, Hanet C, Held C, James S, Jonelid B, Kolls BJ, Leiria T, Leite R, Leonardi S, Lombardi C, Lopes RD, Mahaffey KW, Malagutti P, Mathews R, Mehta RH, Melloni C, Piccini JP, Rodriques Soares P, Roe MT, Shah BR, Sinnaeve PR, Stashenko G, Szczech LA, Tricoci P, Truffa A, Valgimigli M, Varenhorst C, Vranckx P, Williams J, Huang Z, Kilaru R, Lokhnygina Y, White JA, Binkowitz B, He W, Pei J, Ramos MS, Hasbani E, Farras HA, Luz del Valle L, Zapata G, Centeno EP, Hominal M, Beloscar J, Panno M, Berli M, Carlevaro O, Wasserman T, Lembo L, Diez F, Bettinotti M, Allall O, Macin S, Hii C, Bett N, Aroney C, Roberts-Thomson P, Arstall M, Horowitz J, Prasan A, Farshid A, Rankin J, Duffy S, Sinhal A, Hendricks R, Waites J, Hill A, French J, Adams M, Soward A, Dick R, Jepson N, Nelson G, Thompson P, Huber K, Neunteufl T, Pachinger O, Leisch F, Siostrzonek P, Roithinger F, Pieske B, Weber H, Eber B, Zenker G, Sinnaeve P, Roosen J, Vervoort G, Coussement P, Striekwold H, Boland J, Vranckx P, Van Dorpe A, Dujardin K, Mertens D, Vanneste L, Celen H, Lesseliers H, Vrolix M, Leone A, De Maeseneire S, Hellemans S, Silva FA, Franken M, Moraes JB Jr, Mora R, Michalaros Y, Perin M, Guimaraes AE, da Silva DG, Mattos MA, Alves AR Jr, Hernandes ME, Golin V, da Silva SA, Ardito W, Dery JP, Mukherjee A, Tanguay JF, Kornder J, Lutchmedial S, DeGrace M, Klinke P, Constance C, Nogareda G, Wong G, MacDonald P, Senaratne M, Rupka D, Halperin F, Ramanathan K, Natarajan M, Lai C, Brossoit R, Tymchak W, Rose B, Dupuis R, Mansour S, Bata I, Zadra R, Turek M, Madan M, Le May M, Leon L, Perez L, Yovaniniz P, Pedemonte O, Campos P, Prieto JC, Pincetti C, Sepulveda P, Li W, Zhao R, Li Z, Yang Y, Chen J, Li H, Jiang Y, Li D, Qu P, Huang Z, Sun Y, Zheng Y, Zhou C, Zhang F, Wei M, Wang D, Huo Y, Chen J, Lemus J, Fernandez RL, Jaramillo C, Ochoa J, Velez S, Cano N, Lutz J, Botero R, Jaramillo M, Saaib J, Sanchez G, Hernandez H, Mendoza F, Isaza D, Rizcala A, Urina M, Polasek R, Motovska Z, Zemanek D, Ostransky J, Kettner J, Spinar J, Groch L, Ramik C, Stumar J, Linhart A, Pleva L, Niedobova E, Macha J, Vojacek J, Stipal R, Galatius S, Eggert S, Mickley H, Egstrup K, Pedersen O, Hvilsted L, Sykulski R, Skagen K, Dodt K, Klarlund K, Grande P, Husted S, Jensen G, Melchior T, Sjoel A, Steffensen FH, Airaksinen KE, Laukkanen JA, Syvanne MS, Kotila MJ, Mikael K, Naveri HK, Hekkala AM, Mustonen JN, Halkosaari M, Ohlmann P, Khalife K, Montalescot G, Dibon O, Hirsch JL, Furber A, Nguyen-Khac JO, Delarche N, Probst V, Lim P, Bayet G, Dauphin R, Levai L, Galinier M, Belhassane A, Wiedemann JY, Fouche R, Coisne D, Henry P, Schiele F, Boueri Z, Vaquette B, Davy JM, Cottin Y, D'Houdain F, Danchin N, Cassat C, Messner P, Elbaz M, Coste P, Zemour G, Maupas E, Feldman L, Soto FX, Ferrari E, Haltern G, Heuer H, Genth-Zotz S, Loges C, Bode C, Stellbrink C, Terres W, Ferrar M, Zeymer U, Brachmann J, Mudra H, Vohringer HF, vom Dah J, Kreuzer J, Hill S, Kleinertz K, Kadel C, Appel KF, Nienabe C, Behrens S, Frantz S, Mehrhof F, Krings P, Hengstenberg C, Lueders S, Hanefel C, Krulls-Munch J, Dorse T, Leschke M, Nogai K, Butter C, Darius H, Fichtlscherer HP, Schmitt C, Kasisk HP, Dorr M, Fran N, Jereczek M, Wiemer M, Nickenig G, Boudriot E, Werner G, Altila T, Strasser R, Baldus S, Desaga M, Buerke M, Land S, Schunkert H, Schulze HO, Holmer S, Sohn HY, Burkhardt W, Lauer B, Schwimmbeck P, Schoeller R, Lapp H, Gross M, Kindermann I, Schuster P, Yu CM, Lee S, Merkely B, Apro D, Lupkovics G, Edes I, Ungi I, Piroth Z, Csapo K, Dezsi CA, Herczeg B, Sereg M, Butnaru A, Lewis B, Rosenschein U, Mosseri M, Turgeman Y, Pollak A, Shotan A, Hammerman H, Rozenman Y, Gottlieb S, Atar S, Weiss A, Marmor A, Iakobishvili Z, Valgimigli M, Mascia F, De Cesare N, Piovaccari G, Ceravolo R, Fiscella A, Salvioni A, Silvestri O, Moretti L, Severi S, Carmina MG, De Caterina R, Fattore L, Terrosu P, Trimarco B, Ambrosio G, Ardissino D, Uguccioni L, Auguadro C, Gregorio G, De Ferrari G, Testa R, Evola R, De Servi S, Sganzerla P, Vassanelli C, Brunelli C, Scherillo M, Tamburino C, Limido A, Luzza F, Percoco GF, Sinagra G, Volpe M, Crea F, Fedele F, Rasetti G, Cinelli F, Merlini P, Sisto F, Biancoli S, Fresco C, Corrada E, Casolo G, Santini M, D'Alessandro B, Antoniucci D, Tuccillo B, Assennato P, Puccioni E, Pasquetto G, Perna GP, Morgagni G, Takizawa K, Kato K, Oshima S, Yagi M, Asai T, Kamiya H, Hirokami M, Sakota S, Sueyoshi A, Shimomura H, Hashimoto T, Miyahara M, Matsumura T, Nakao K, Kakuta T, Nakamura S, Nishi Y, Kawajiri K, Nagai Y, Takahashi A, Ikari Y, Hara K, Koga T, Fujii K, Tobaru T, Tsunoda R, Uchiyama T, Hirayama H, Fujimoto K, Sakurai S, Tanigawa T, Ohno M, Yamamoto E, Ikuta S, Kato A, Kikuta K, Takami A, Chong WP, Ong TK, Yusof A, Maskon O, Kahar A, Cornel JH, Breedveld RW, Bendermacher PE, Hamer BJ, Oude Ophuis AJ, Nierop PR, Westendorp IC, Beijerbacht HP, Herrman JP, van 't Hof AW, Troquay RP, van der Meer P, Peters RH, van Rossum P, Liem A, Pieterse MG, van Eck JW, van der Zwaan C, Pasupati S, Elliott J, Tisch J, Hart H, Luke R, Scott D, Ternouth I, White H, Hamer A, Harding S, Wilkins G, O'Meeghan T, Harrison N, Nilsen D, Nordrehaug JE, Thalamus J, Aaberge L, Brunvand H, Lutterbey G, Omland TM, Eritsland J, Wiseth R, Aase O, Campos C, Horna M, Toce L, Salazar M, Przewlocki T, Ponikowski P, Kasprzak J, Ruzyllo W, Kopaczewski J, Musial W, Mazurek W, Kawecka-Jaszcz K, Pluta W, Dobrzycki S, Loboz-Grudzien K, Lewczuk J, Karwowski D, Grajek S, Dudek D, Trusz-Gluza M, Kornacewicz-Jach Z, Gil R, Providencia L, Ferreira J, Gavina C, Ferreira R, Martins D, Garcia-Rinaldi R, Ufret R, Vazquez-Tanus J, Banchs H, Wong A, Tan HC, Guerra M, Ebrahim I, Roux J, Blomerus P, Saaiman A, Corbett C, Pillay T, Freeman V, Horak A, Zambakides C, Burgess L, Dalby A, Yoon JH, Ahn TH, Park SJ, Gwon HC, Seong IW, Kim HS, Jeong MH, Kim YD, Chae SC, Cequier A, Hernandez JM, Pique M, Fernandez Portales J, Paz MA, Lopez Palop R, Iniguez A, Diaz Fernandez J, Alvarez P, Sanz E, Heras M, Sala J, Goicolea J, Cruz Fernandez J, Serra A, Fernandez Ortiz A, Calle G, Barriales V, Albarran A, Curos A, Molano Casimiro FJ, Suarez MA, Franco SN, Bayon J, Suarez J, Belchi J, Moreu J, San Martin M, Melgares Moreno R, Aguirre Salcedo J, Gonzalez Juanatey JR, Martinez Romero P, Galache Osuna JG, Albertsson P, Diderholm E, Lycksell M, Held C, Rasmanis G, Swahn E, Cherfan P, Christensen K, Lundman P, Larson LE, Vasko P, Pripp CM, Johansson A, Moccetti T, Corti R, Pieper M, Mach F, Eberli F, Jeger R, Rickli H, Vogt P, Windecker S, Wu CJ, Kao HL, Charng MJ, Chang KC, Chen ZC, Tsa CD, Shyu KG, Lai WT, Hsieh IC, Hou JY, Yeh HI, Ueng KC, Yin WH, Erkan A, Timurkaynak T, Yigit Z, Yilmaz M, Boyaci A, Sahin M, Goktekin O, Bozkurt E, Ercan E, Yildirir A, Storey RF, Muthusamy R, Keeling P, Levy T, Zaman A, Cohen A, Gorog D, Baumbach A, Oldroyd K, Kadr H, Tait G, Bellenger N, Davis G, Shakespeare C, Senior R, Bruce D, Uren N, Trouton T, Ahsan A, Hamed A, Malik I, Sarma J, Millar-Craig M, Robson H, Kennon S, Sprigings D, Brodie B, Kang GS, Tricoci P, Thomas G, Cheng SC, Espinoza A, Kassas S, Jafar Z, Kumar P, Izzo M, Wiseman A, Chandna H, Felten W, D'Urso M, Gudipati CR, Coram R, Gill S, Bengtson J, Chang M, Raisinghani A, Blankenship J, Harbor WF, Kraft P, Ashraf R, Chambers J, Albirini A, Malik A, Ziada K, Slepian M, Taussig A, Vernon H, Jetty P, Islam MA, Canaday D, Martin T, Burchenal JJ, Gencheff N, Nygaard T, Panchal V, Merritt R, Abrahams L, Lambert C, Reyes P, Leimbach W, Chhabra A, Caputo R, Imburgia M, Erickson B, Kleiman N, Hunter J, Dehning M, Graham B, Strain J, White JK, McGarvey J Jr, Henderson D, Treasure C 2nd, Mirro M, Pancholy S, Helmy T, Westerhausen D, Dib N, Penny W, Kim H, DeGregorio M, Jay D, Kmonicek J, Berlowitz M, Starling M, Langevin E, Nelson R, Singer A, Siachos A, Gibson G, Parrott C, Held J, Puleo P, Wolford T, Omar B, Brilakis E, Lewis S, Heller L, Brener S, Addo T, Lieberman S, Eisenberg D, Feldman R, Waksman R, Waltman J, Schulman S, Bounds C, Voyce S, Batchelor W, Dobies D, Pasnoori V, Chandrashekhar Y, Vetrovec G, Azrin M, Spriggs D, Siachos A, Hirsch C, Smucker M, Chetcuti S, Stella R, Levite H, Shoukfeh M, Vidovich M, Saucedo J, Fintel D, Low R, Gellman J, Ahsan C, Unks DM, Tolleson T, Ceccoli H, Aggarwal K, Bhaktaram V, Olson C, DeCaro M, Kaluski E, Mehta V, Puma J, Singh V, Fulmer J, Lewis D, Khadra S, Staniloae C, East M, Sundram PS, Anderson J, Wasserman H, Guy D, Brill D, Kruse K, Ebrahimi R, Nguyen T, Keating F, Srivastava R, Wassmer P, Todd J 3rd, Stein M, Hamzeh I, Laxson D, Hodson R, Puri S, Vijayaraghavan K, Gazmuri R, Chu A, Vijay N, Rabinowitz A, Block T, Agarwal H, Martin J, Zetterlund P, Fortuin D, MacDonell A 3rd, Zouzoulas S, Chepuri V, Vijayaraghavan K, Schmalfuss C, Karve M, Aviles R, Lieberman E, Vidovich M, Amlani M, Murphy S, Shapiro T, Herzog E, Ariani K, Bhagwat R, Hockstad E, Kai W, Saririan M, Roth R, Weiland F, Atassi K, Harjai K, Muhlestein J, Marsh R, Shokooh S, Nahhas A, Labroo A, Mayor M, Koshy S, Tariq M, Rayos G, Jones S, Klugherz B, Dewey R, Rashid HU, Wohns D, Feiring A, Bowles M, Rohrbeck S, Monroe VS, De Gottlieb A, Gumm D, Brown C 3rd, Chang D, Kalaria V, Minisi A, Joumaa M, Josephson R, Kleczka J, Silver K, Coleman P, Brachfeld C, Saltiel F, Reiner J, Carell E, Hanovich G, Rosenberg M, Das G, Blick D.

Author information

  • 1Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. pierluigi.tricoci@duke.edu

Abstract

BACKGROUND:

Vorapaxar is a new oral protease-activated-receptor 1 (PAR-1) antagonist that inhibits thrombin-induced platelet activation.

METHODS:

In this multinational, double-blind, randomized trial, we compared vorapaxar with placebo in 12,944 patients who had acute coronary syndromes without ST-segment elevation. The primary end point was a composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization.

RESULTS:

Follow-up in the trial was terminated early after a safety review. After a median follow-up of 502 days (interquartile range, 349 to 667), the primary end point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of 6471 patients receiving placebo (Kaplan-Meier 2-year rate, 18.5% vs. 19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01; P=0.07). A composite of death from cardiovascular causes, myocardial infarction, or stroke occurred in 822 patients in the vorapaxar group versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard ratio, 0.89; 95% CI, 0.81 to 0.98; P=0.02). Rates of moderate and severe bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group (hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P<0.001). Intracranial hemorrhage rates were 1.1% and 0.2%, respectively (hazard ratio, 3.39; 95% CI, 1.78 to 6.45; P<0.001). Rates of nonhemorrhagic adverse events were similar in the two groups.

CONCLUSIONS:

In patients with acute coronary syndromes, the addition of vorapaxar to standard therapy did not significantly reduce the primary composite end point but significantly increased the risk of major bleeding, including intracranial hemorrhage. (Funded by Merck; TRACER ClinicalTrials.gov number, NCT00527943.).

PMID:
22077816
[PubMed - indexed for MEDLINE]
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