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N Engl J Med. 2010 Sep 2;363(10):930-42. doi: 10.1056/NEJMoa0909475.

Dose comparisons of clopidogrel and aspirin in acute coronary syndromes.

Collaborators (572)

Mehta SR, Yusuf S, Chrolavicius S, Ajani AE, Avezum A, Bassand JP, Boden WE, Budaj A, Cardona-Muñoz EG, Col J, Commerford PJ, Di Pasquale G, Diaz R, Eha J, Eikelboom JW, Faxon DP, Flather M, Foley D, Fox KA, Franzosi MG, Granger CB, Gupta M, Jolly S, Joyner C, Karatzas N, Kastrati A, Kim JH, Koh TH, Lanas F, Lewis B, Macaya C, Moccetti T, Montalescot G, Niemelä KO, Ongen Z, Orlandini A, Pais P, Peters RJ, Piegas L, Probstfield J, Rankin JM, Ruda M, Rumboldt Z, Rupprecht HJ, Steg PG, Tanguay JF, Valentin V, Varigos J, White HD, Widimsky P, Xavier D, Zhu J, Zhu JR, Gaudin C, Marchese C, Bouancheau C, Blumenthal M, Hornick P, Saini R, Atra M, Bainey K, Barsan A, Benedek I, Borislav G, Bornstein N, Cottin Y, Czepiel A, DeRaedt H, Dorobantu M, Fodor G, Gardinale E, Gross B, Guimaraes H, Halon D, Happola O, Hartikainen J, Himbert D, Hua Q, Iyengar SS, Kalvach P, Kies B, Kim CJ, Laine M, Lang S, Maggioni A, Massaro A, Morillo C, Narendra J, Naslund U, Nisanci Y, Okay T, Peeters A, Penicka M, Perakis A, Piplis A, Pizzolato G, Polic S, Renkin J, Rokoss M, Runev N, Siva A, Sorokin E, Stockins B, Turrazza F, Valettas N, Yang Y, Zaborski J, Zimlichman R, Sleight P, Anderson JL, DeMets DL, Hirsh J, Holmes DR Jr, Johnstone DE, Jedrzejowski B, Robinson A, Lawrence M, Pogue J, Afzal R, Blake L, Chen W, Di Diodato S, Manojlovic R, Mastrangelo L, Mead A, Pasadyn E, Sovereign T, Wasala L, Amuchastegui M, Bustamante Labarta MH, Caime GD, Cartasegna L, Covelli GR, Fuselli JJ, Garrido MA, Grinfeld LR, Hominal MA, Hrabar AD, Labarta GB, Licheri AJ, Lobo Marquez LL, Luciardi HL, Majul CR, Pomposiello JC, Prado AD, Rodriguez AO, Salzberg S, Sanchez AS, Santos DA, Schygiel PO, Zapata GO, Arstall M, Binnekamp MF, Brieger D, Colquhoun DM, Eccleston DS, Hale S, Hendriks R, Hill AT, Ruane S, Singh BB, Thompson PL, Thompson SJ, Walsh W, Worthley MI, Delle-Karth G, Huber K, Beauloye C, Dangoisse V, Janssens L, Janssens S, Marcovitch O, Massart PE, Vincent M, Vrolix MC, Abrantes J, Ardito WR, Baruzzi AC, Botelho RV, Carneiro JK, Carvalho AC, Coutinho M, Dutra O, Jaeger CP, Kormann AP, Maia LN, Manenti E, Mangione JA, Marin-Neto JA, Marino RL, Markman AC, Mendonça SA, Mora RD, Paiva MS, Polanczyk CA, Rabelo A Jr, Reis G, Reis HL, Rossi PR, Saporito WF, Saraiva JF, Sousa AC, Timerman A, Tumelero RT, Doganov AR, Grigorov GV, Grigorov MV, Jorgova JB, Manukov IH, Postadzhiyan AS, Béliveau P, Berlingieri JC, Borts D, Brons SW, Burton JR, Chan YK, Cockhill CT, Constance C, Déry JP, Dzavik V, Fell DA, Fitchett DH, Fung AY, Gosselin G, Hussain F, Huynh T, Kieu CV, MacCallum GC, Madan M, Montigny M, Nigro F, Pallie S, Pelletier JP, Phaneuf DC, Salehian O, Schampaert E, Senaratne M, Shariff S, Singh I, Syed JA, Alcaino ME, Garcés E, Lamich R, Lichter AP, Lopetegui M, Perez LA, Sepulveda PA, Chen JY, Chen YD, Fu GS, Ge JB, Han YL, He B, Ke YN, Li HW, Li TC, Li WJ, Li WM, Li ZQ, Lv SZ, Ma GS, Qi GX, Qiao SB, Sun YX, Wang DW, Wang JA, Wang X, Wei M, Xu B, Yang TL, Yang XC, Yuan ZY, Zhang SY, Zhu JH, Bergovec M, Mirat J, Padovan M, Samardzic P, Aschermann O, Branny M, Cervinka P, Coufal Z, Dvorak J, Gorican K, Hajek P, Jelínek P, Kala P, Marcinek G, Oscipovský M, Padour M, Richter M, Rokyta R, Spacek R, Vencour D, Vojacek J, Airaksinen KE, Niemela MJ, Vikman S, Belle L, Caussin C, Ducrocq G, Ferrari E, Fouché RP, Geslin GP, Lim P, Pacouret G, Schiele F, Appel KF, Atmowihardjo I, Brachmann J, Buerke M, Burkhardt W, Desaga MP, Fichtlscherer S, Fischer D, Genth-Zotz S, Hoffmann S, Klauss V, Nienaber CA, Nuellen CM, Schmidt AE, Schoebel WA, Schunkert H, Schwimmbeck P, Strasser RH, Vom Dahl J, Von Hodenberg E, Willenbrock R, Zotz RJ, Alexopoulos D, Nanas JN, Baxi HA, Bhaskara Rao M, Bhatia V, Chandwani P, Dwivedi S, Haridas KK, Jain RK, Kerkar PG, Mahorkar UK, Parikh KH, Patel TM, Pinto BV, Puri A, Ramesh SS, Rao VS, Sawhney JP, Shetty KP, Sinha N, Srinivas A, Tongia RK, Trivedi SK, Vaishnav SN, Varma S, Crean PA, Crowley JJ, McCann H, McGrath F, Arbel J, Finkelstein A, Halabi S, Halabi M, Marmor A, Meisel SR, Pollak A, Porter A, Rechavia E, Rozenman Y, Turgeman Y, Weiss AT, Bolognese L, Bovenzi F, Cavallini C, Chiarella F, De Luca G, Galli M, Galvani M, Greco C, Lettino M, Limbruno U, Meneghetti P, Nassiacos D, Pes R, Piovaccari G, Pirelli S, Rossi ML, Salvioni A, Steffenino G, Tredici S, Zanini R, Erglis A, Joksas V, Unikas R, Chong WP, Fong AY, Lee CY, Zambahari R, Arenas JL, Cardona-Müller D, Ledesma M, Dunselman PH, Herrman JP, Michels HR, ten Berg JM, Benatar JR, Devlin GP, Elliott JM, Harding SA, Patel H, Scott DS, Wilkins GT, Buszman PE, Dalkowski M, Drzewiecki A, Gessek J, Gil RJ, Hiczkiewicz JJ, Jaworska K, Kalarus Z, Kardaszewicz P, Kawecki D, Kopaczewski JF, Kornacewicz-Jach Z, Kubica J, Kuźniar J, Miekus P, Musiał WJ, Rynkiewicz A, Trznadel S, Winek D, Włodarczyk AS, Wrzosek B, Zinka E, Benedek TM, Capalneanu R, Dragulescu SI, Ginghina C, Onut RA, Berns SA, Fokina EG, Gruzdev AK, Kalinina SG, Kosmachova ED, Markov VA, Ewe SH, Kurray P, Studencan M, Chin A, Theron HD, Cho JM, Choe KH, Chung NS, Her SH, Jeong MH, Kim DS, Kim HS, Kim MH, Kim SK, Kim YK, Park SW, Rhim CY, Shin EK, Albarran A, Angel J, Avanzas P, Bosa F, Calle G, Cequier AR, Cubero JM, Delcastillo A, Diaz JF, Fdez Portales J, Fernandez-Ortiz A, Hernández-García JM, Iglesias LF, Lekuona I, Lopez-Palop R, Masotti M, Picó-Aracil F, Puigfel M, Sabate M, Suarez MA, Vazquez Gonzalez N, Herlitz JD, Hot-Bjelak A, Erne P, Hille R, Keller PF, Rickli H, Rossi MG, Abaci A, Bozkurt GG, Erdinler I, Gürmen T, Sahin M, Baumbach A, De Belder AJ, Gorog DA, Manoharan G, Smith D, Acheatel RJ, Ariani MK, Bailey SR, Bates ER, Bhagwat RS, Bohle D, Burchenal JE, Chambers JW, Chandna H, Chandrashekhar YS, Cheek HB, Clemson BS, Dewey RC, Drenning DH, Ebrahimi R, Fail PS, Fishbein GJ, Fitzmorris SJ, Goldberg SL, Habet KJ, Hassel CD, Izzo MR, Karve MM, Kieval J, Klugherz BD, Larrain G, Lawson WE, Leesar M, Lo EL, Lohavanichbutr K, Maddux JT, Magno JH, Mahmud E, Makam SN, Mann JT, Marsh RC, Marshalko SJ, Martinez-Arraras J, Massaro JP, Mavromatis K, Mayer NJ, McLellan BA, McPherson JA, Mooss AN, Mostel E, Nadar VK, Palmeri ST, Pandey P, Pasnoori V, Pothula A, Prashad R, Reis GJ, Rivera E, Safley DM, Santos RM, Schoondyke JW, Shakir AA, Sharma MK, Shoukfeh MF, Singh N, Smith CR, Stoltz SM, Strain J, Tan WA, Thai HM, Thew ST, Ver Lee PN, Vicari RM, Voyles WF, Walder JS, Wolfe CL, Wu WC.

Erratum in

  • N Engl J Med. 2010 Oct 14;363(16):1585.

Abstract

BACKGROUND:

Clopidogrel and aspirin are widely used for patients with acute coronary syndromes and those undergoing percutaneous coronary intervention (PCI). However, evidence-based guidelines for dosing have not been established for either agent.

METHODS:

We randomly assigned, in a 2-by-2 factorial design, 25,086 patients with an acute coronary syndrome who were referred for an invasive strategy to either double-dose clopidogrel (a 600-mg loading dose on day 1, followed by 150 mg daily for 6 days and 75 mg daily thereafter) or standard-dose clopidogrel (a 300-mg loading dose and 75 mg daily thereafter) and either higher-dose aspirin (300 to 325 mg daily) or lower-dose aspirin (75 to 100 mg daily). The primary outcome was cardiovascular death, myocardial infarction, or stroke at 30 days.

RESULTS:

The primary outcome occurred in 4.2% of patients assigned to double-dose clopidogrel as compared with 4.4% assigned to standard-dose clopidogrel (hazard ratio, 0.94; 95% confidence interval [CI], 0.83 to 1.06; P=0.30). Major bleeding occurred in 2.5% of patients in the double-dose group and in 2.0% in the standard-dose group (hazard ratio, 1.24; 95% CI, 1.05 to 1.46; P=0.01). Double-dose clopidogrel was associated with a significant reduction in the secondary outcome of stent thrombosis among the 17,263 patients who underwent PCI (1.6% vs. 2.3%; hazard ratio, 0.68; 95% CI, 0.55 to 0.85; P=0.001). There was no significant difference between higher-dose and lower-dose aspirin with respect to the primary outcome (4.2% vs. 4.4%; hazard ratio, 0.97; 95% CI, 0.86 to 1.09; P=0.61) or major bleeding (2.3% vs. 2.3%; hazard ratio, 0.99; 95% CI, 0.84 to 1.17; P=0.90).

CONCLUSIONS:

In patients with an acute coronary syndrome who were referred for an invasive strategy, there was no significant difference between a 7-day, double-dose clopidogrel regimen and the standard-dose regimen, or between higher-dose aspirin and lower-dose aspirin, with respect to the primary outcome of cardiovascular death, myocardial infarction, or stroke. (Funded by Sanofi-Aventis and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00335452.)

Comment in

PMID:
20818903
[PubMed - indexed for MEDLINE]
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