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1. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients.

Author

Chin CT, Boden WE, Roe MT, Neely B, Neely ML, Leiva-Pons JL, Corbalán R, Gottlieb S, Dalby AJ, Armstrong PW, Prabhakaran D, Fox KA, White HD, Ohman EM, Winters KJ, and Schiele F

Subjects
Acute Coronary Syndrome complications, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome mortality, Aged, Aspirin administration & dosage, Clopidogrel, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Hemorrhage chemically induced, Hospitalization, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction etiology, Platelet Aggregation Inhibitors adverse effects, Prasugrel Hydrochloride administration & dosage, Proportional Hazards Models, Risk Assessment, Risk Factors, Stroke etiology, Ticlopidine administration & dosage, Ticlopidine adverse effects, Time Factors, Treatment Outcome, Acute Coronary Syndrome drug therapy, Platelet Aggregation Inhibitors administration & dosage, Ticlopidine analogs & derivatives
Abstract

Objective: We investigated whether prior clopidogrel influenced long-term ischaemic and bleeding risks and modified the randomised treatment effect of clopidogrel versus prasugrel among medically managed patients with acute coronary syndromes (ACS) treated with dual antiplatelet therapy., Methods: Medically managed patients with ACS in the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial were randomised to clopidogrel versus prasugrel (plus aspirin), stratified by prior clopidogrel use. From the analysis population (n=8927), we compared two groups: 'clopidogrel in-hospital (n=6513)' (clopidogrel started ≤72 h of presentation for index ACS event) and 'prior-clopidogrel (n=2414)' (on clopidogrel ≥5 days before index hospitalisation). Treatment-related differences in ischaemic (all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stroke and the composite of CV death/MI/stroke) and bleeding outcomes (severe/life-threatening or moderate bleeding events based on Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria) through 30 months were analysed between patients in the two groups., Results: Compared with 'clopidogrel in-hospital,' 'prior clopidogrel' patients were younger (median 64 years vs 66 years, p<0.001), more likely to have prior CV events/revascularisation, and had a higher frequency of CV death, MI or stroke through 30 months (20.8% vs 18.2%, p=0.002), with no difference in bleeding events (2.3% vs 3.4%, p=0.50). Randomised treatment effect (prasugrel vs clopidogrel) was similar for ischaemic and bleeding outcomes in both groups (all pinteraction>0.05)., Conclusions: Patients receiving clopidogrel before admission for ACS and subsequently treated only medically are at higher risk for CV events versus those not previously receiving clopidogrel. More potent antiplatelet inhibition with prasugrel versus clopidogrel did not significantly reduce this risk., Trial Registration Number: NCT00699998., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Published
2016
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2. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization.

Author

Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteză M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, and Ohman EM

Subjects
Aged, Aspirin therapeutic use, Cardiovascular Diseases mortality, Cardiovascular Diseases prevention & control, Clopidogrel, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction epidemiology, Piperazines adverse effects, Platelet Aggregation Inhibitors adverse effects, Prasugrel Hydrochloride, Purinergic P2 Receptor Antagonists adverse effects, Purinergic P2 Receptor Antagonists therapeutic use, Stroke epidemiology, Thiophenes adverse effects, Ticlopidine adverse effects, Ticlopidine therapeutic use, Acute Coronary Syndrome drug therapy, Angina, Unstable drug therapy, Myocardial Infarction drug therapy, Piperazines therapeutic use, Platelet Aggregation Inhibitors therapeutic use, Thiophenes therapeutic use, Ticlopidine analogs & derivatives
Abstract

Background: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated., Methods: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel., Results: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group., Conclusions: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).

Published
2012
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3. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients.

Author

Chee Tang Chin, Boden, William E., Roe, Matthew T., Neely, Benjamin, Neely, Megan L., Leiva-Pons, Jose L., Corbalán, Ramón, Gottlieb, Shmuel, Dalby, Anthony J., Armstrong, Paul W., Prabhakaran, Dorairaj, Fox, Keith A. A., White, Harvey D., Magnus Ohman, E., Winters, Kenneth J., Schiele, Francois, Chin, Chee Tang, and Ohman, E Magnus

Subjects
TREATMENT of acute coronary syndrome, CLOPIDOGREL, CORONARY heart disease treatment, HEART diseases, THERAPEUTICS, CARDIOVASCULAR disease treatment, ASPIRIN, COMBINATION drug therapy, CLINICAL trials, COMPARATIVE studies, DRUG administration, HEMORRHAGE, HOSPITAL care, RESEARCH methodology, MEDICAL cooperation, MYOCARDIAL infarction, RESEARCH, RISK assessment, STROKE, TICLOPIDINE, TIME, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness, PROPORTIONAL hazards models, BLIND experiment, PLATELET aggregation inhibitors, ACUTE coronary syndrome, KAPLAN-Meier estimator, DISEASE complications, DIAGNOSIS
Abstract

Objective: We investigated whether prior clopidogrel influenced long-term ischaemic and bleeding risks and modified the randomised treatment effect of clopidogrel versus prasugrel among medically managed patients with acute coronary syndromes (ACS) treated with dual antiplatelet therapy.Methods: Medically managed patients with ACS in the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes (TRILOGY ACS) trial were randomised to clopidogrel versus prasugrel (plus aspirin), stratified by prior clopidogrel use. From the analysis population (n=8927), we compared two groups: 'clopidogrel in-hospital (n=6513)' (clopidogrel started ≤72 h of presentation for index ACS event) and 'prior-clopidogrel (n=2414)' (on clopidogrel ≥5 days before index hospitalisation). Treatment-related differences in ischaemic (all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stroke and the composite of CV death/MI/stroke) and bleeding outcomes (severe/life-threatening or moderate bleeding events based on Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria) through 30 months were analysed between patients in the two groups.Results: Compared with 'clopidogrel in-hospital,' 'prior clopidogrel' patients were younger (median 64 years vs 66 years, p<0.001), more likely to have prior CV events/revascularisation, and had a higher frequency of CV death, MI or stroke through 30 months (20.8% vs 18.2%, p=0.002), with no difference in bleeding events (2.3% vs 3.4%, p=0.50). Randomised treatment effect (prasugrel vs clopidogrel) was similar for ischaemic and bleeding outcomes in both groups (all pinteraction>0.05).Conclusions: Patients receiving clopidogrel before admission for ACS and subsequently treated only medically are at higher risk for CV events versus those not previously receiving clopidogrel. More potent antiplatelet inhibition with prasugrel versus clopidogrel did not significantly reduce this risk.Trial Registration Number: NCT00699998. [ABSTRACT FROM AUTHOR]

Published
2016
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4. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

Author

L. Wang, T. Stys, William E. Boden, R. H. Urbano, D. M. Olinic, Karen S. Pieper, A. Kuijper, E. Soh, J. Nicolau, Jadwiga Nessler, William J. Rogers, Ernesto Rivera, R. Braam, H. Kadr, J. Csikasz, B. Boichev, Prafulla Kerkar, I. Kraiz, R. Babu, Ali Aydinlar, D. Safley, O. Nguyen-Khac, P. Chua, W. Buchanan, C. A. Morales, A. Abyankar, A. Srinivas, S. Genth-Zotz, J. Rocha Faria Neto, D. Drenning, L. Moretti, S. Varma, D. Roth, C. Matei, Jane E. Onken, H. Tumbev, P. Keeling, Xian Li, N. Ciglenecki, Shahyar M. Gharacholou, P. P. Goh, D. Sporn, M. Chang, Marcin Gruchała, R. Foreman, Bogdan Minescu, S. Nawaz, N. Alexeeva, Y. Shalev, C. Fastabend, L. van Zyl, J. F. Certic, J. Longo, J. Wang, K. Dave, Olivier Morel, F. Maatouk, Y. El Rakshy, J. Giacomini, P. Lazov, R. Marino, Dimitar Raev, M. Y. Chan, L. Z. Dextre, Y. Hao, P. Sepulveda, K. Ramshev, C. Bayron, Ameer Kabour, Alon Marmor, Luciano Moreira Baracioli, H. Marais, Rajendra H. Mehta, R. Breedveld, A. Ben Khalfallah, Kurtulus Ozdemir, I. Westendorp, J. A. Quion, Daniel J. George, D. F. Garcia, J.-P Bassand, G. Szalai, Huw Griffiths, O. Ushakov, M. Tzekova, E. Suprun, A. Mowafy, N. El Mansour, Gail V.W. Johnson, Tereshchenko Sn, W. T. Lai, Petr Widimsky, Hany Ragy, V. R. Castillo, M. Padour, Gilles Montalescot, Louie Tirador, Deepak L. Bhatt, M. Marrinan, S. Promisloff, A. Nambiar, Reginald G.E.J. Groutars, S. R. Lee, J. Cabrera, S. Zhang, András Jánosi, K. Wita, R. Sciborski, Annabelle Rodriguez, P. Sedlon, Jaroslaw D. Kasprzak, A. Faynyk, A. Romero Acuña, M. C. Ramirez, Rakesh Gupta, R. Saligrama, Jacek Gniot, Y. Ke, John H. Alexander, X. Liu, E. Baranov, R. Grzywna, Mukul Sharma, A. Linka, Jarosław Wójcik, Haroon Rashid, M. S. Sanchez, M. Gadkari, B. Rao, James S. Zebrack, Paul W. Armstrong, Francois Schiele, Gracita O. Topacio, Peter J. Casterella, A. Belhassane, P. Golino, F. Plat, P. Roberts-Thomson, K. S. Kim, Stephen D. Wiviott, Mathew T. Roe, Y. D. Chen, I. A. Khan, S. Thanvi, S. Isserman, G. Falck, R. M. Coching, S. C. Stamate, M. Ogorek, K. Danisa, Poul Anders Hansen, M. Medvegy, Amos Katz, R. K. Seerangachar, B. Farah, V. Kale, B. Kusnick, Maurice Pye, M. Mosseri, M. Vatutin, D. Weinstein, Norma Keller, A. Mihov, Ewa Mirek-Bryniarska, N. Adjei, S. Sethi, A. Irimpen, M. Broeders, T. Huynh, K. Niezgoda, P. Samardzic, D. Ziperman, Stuart J. Pocock, T. Arad, J. Lewczuk, M. Amuchastegui, R. Moscoso, B. Dimov, W. A. Ahmad, E. Dalli, P. Laothavorn, S. Shaikh, Helmut U. Klein, J. Menon, H. Colombo, L. Fattore, G. Zarrella, Dorairaj Prabhakaran, N. Viboolkitvarakul, Judith D. Goldberg, Neetika Garg, Y. Hasin, F. Rossi Dos Santos, S. J. Vigo, L. Horbach, O. Prokhorov, H. Moellmann, T. R. Vera, C. E. Botta, Domitilla Russo, M. Rossovskaya, David C. Henderson, Rebecca B. Costello, V. Shcherbak, C. J.P.J. Werter, W. Kus, I. Dobre, P. Marechal, T. Nair, H. Nielsen, J. Waites, J. B. Moraes Junior, T. Römer, J. Senior, P. Ionescu, S. Kalashetti, R. N. Ortega, Gail E. Hafley, G. A. Dan, Apur R. Kamdar, Ruth Ann Greenfield, David F. Kong, J. Bergallo, O. Barnum, Antonis S. Manolis, Sumeet Subherwal, S. Schaefer, A. Figueredo, Habib Gamra, S. Bandyopadhyay, V. Miloradovic, Imran Arif, Peter R. Carroll, M. Demirtas, S. Guidera, G. Rogelio, Naseem Jaffrani, N. Mulvihill, Marvin J. Slepian, Darren K. McGuire, Rohit Kalra, Luís A. Providência, F. Van de Werf, Andras Vertes, J. Xu, C. F. Gamio, R. G. Xuereb, R. F. Ramos, E. Kis, N. Bustros, M. De Luca, S. Zhurba, T. Connelly, S. Singhi, F. Gredler, Serdar Kucukoglu, Francesco Fedele, C. Chavez, Christoph Kadel, Antônio Carlos Sobral Sousa, S. Srimahachota, Igor Kaidashev, J. H. Garcia, I. Teodorescu, Birute Petrauskiene, O. Kracoff, Liwa T. Younis, Alain Bouchard, P. Osmancik, Y. Sun, C. Hammett, S. Sabri, William Wallace, Mehmet Yazici, L. Ermoshkina, Harish Chandna, G. Ramos-Lopez, M. Bronisz, Sergio Luiz Zimmermann, Giuseppe Ambrosio, V. Hergeldjieva, César A. Jardim, A. Rifai, H. Lui, A. Lee, J. Scholz Issa, A. Blenkhorn, P. Micale, V. Barbarich, C. Maccallum, Peter J. Grant, G. Topacio, N. Budassi, J. Yan, Keith A.A. Fox, Y. Xia, Jan H. Cornel, A. Rafael, Paul Hermany, S. Potthoff, Mohsin A.F. Khan, Pierre Coste, Neal Ready, N. T. Duda, M. Reyes, A. Chandran, I. G. Gordeev, Anne W. Beaven, B. J.B. Hamer, C. Treasure, Pravin Manga, M. R. Babarskiene, T. Devedzhiev, Alberto Menozzi, L. Lenarz, N. Llerena, Thomas F. Lüscher, Giovânio Vieira da Silva, Y. Malynovsky, L. Ramanathan, M. Belicova, M. O. Ibarra, D. Chew, R. Castillo, M. Kesselbrenner, A. H. Li, E. Baldjiev, M. El-Harari, S. H. Hur, S. Chiaramida, C. E. Chiang, Viliam Fridrich, L. R. Cartasegna, A. Yagensky, Steven E. Hearne, Gregory Pavlides, Witold Rużyłło, Y. Chandrashekhar, S. Welka, H. Petijean, Jose L. Leiva-Pons, Shaul Atar, Andrzej Lubiński, S. Zhao, János Tomcsányi, Narinder Singh, D. Banker, T. Boyek, H. Ebinc, N. Calambur, A. Mouhaffel, M. Creteanu, H. Huang, J. O. Jeong, E. Goudreau, D. Alexopoulos, E. Duronto, S. Car, O. Bashkirtsev, J. Mandak, V. Papademetriou, David O. Williams, Oscar Pereira Dutra, R. Baman, T. J. Hong, J. O. Ibañez, D. L. Gomez, R. K. Jain, R. Jozwa, L. Di Lorenzo, Matthew Wilson, Christian W. Hamm, A. Buakhamsri, Nikitas Moschos, Ashok Kumar, A. Kadiiski, C. Y. Lee, M. Opazo, J. Tang, E. Ferrari, P. Colon-Hernandez, Jean-Pierre Déry, B. Goloborodko, L. Gimple, Diego Ardissino, M. Bergovec, S. Thew, Dariusz Dudek, K. Tang, P. A.G. Zwart, A. Deshpande, S. Sathe, Yves Cottin, V. Pai, O. Koval, J. Lesnik, Pavan S. Reddy, A. Espinoza, Rungroj Krittayaphong, Carisi Anne Polanczyk, E. Kukuy, L. Tejada, J. Nobel, Renato D. Lopes, J. Bagatin, A. Manolova, E. Boudriot, A. Godoy, N. Perepech, Christopher D. Olympios, A. E. Guimarães, James Harris, Aref Rahman, D. Foley, H. J. Kruik, J. Bruguera I Cortada, I. Fotiadis, A. Bharani, Petar Otasevic, Eileen Brown, N. Gratsiansky, J. E. Poulard, Vladimir Gašparović, Habib Haouala, A. de Belder, J. Schmedtje, Lilia Nigro Maia, J. Cobos, Werner Benzer, E. Korban, A. U. Quraishi, X. Hong, A. Bazzi, P. Kotha, L. Gubolino, H. Ingersoll, Debra Marshall, Udo Sechtem, Sandipan Dutta, G. Frago, Anthony Mathur, Shaun G. Goodman, William Bachinsky, A. Hamer, Jaime Gomez, Patrizio Lancellotti, Vance Wilson, L. White, P.P. Mohanan, Aleksandar Knezevic, Sorin J. Brener, Susanna R. Stevens, H. Luquez, S. K. Lee, P. E. Leaes, P. Benjarge, T. Tu, Z. Coufal, N. Koliopoulos, Mahmut Şahin, X. Huang, S. Boldueva, J. De Souza, N. Chidambaram, S. Zolyomi, K. G. Shyu, H. Montecinos, A. Piombo, Wladmir Faustino Saporito, R. L. Kulkarni, I. Szakal, G. Arminio, M. Elbaz, Samir Pancholy, Jang Ho Bae, Giuseppe Musumeci, S. B. Zouari, A. Chois, D. Wojciechowski, A. Bakbak, E. Bozkurt, Kenneth J. Winters, R. Raugaliene, D. Sarkar, J. M. Alegret, Hubertus Heuer, E. Bobescu, E. Roncallo, R. Carlsson, R. Craig McLendon, L K Newby, K. Zrazhevskiy, João Pedro Ferreira, A. Haidar, D. Tellez, Robert Olszewski, Shmuel Gottlieb, H. Jure, A. Garcia Escudero, S. Sengupta, V. Ochean, W. Kostuk, G. Range, F. Leroy, G. Parale, R. Fernandez, M. Fulwani, M. Padovan, Y. Dovgalevskiy, Kreton Mavromatis, H. Hart, Y. G. Ko, F. Seixo, V. Bisne, J. McGarvey, Kimberly L. Blackwell, John H. Strickler, Sanjay Kumar, A. Bordonava, L. Egorova, C. Patocchi, A. Karczmarczyk, Chiara Melloni, Piyamitr Sritara, M. Anastasiou-Nana, Roman Szełemej, K. Penchev, D. Morales, M. Tokmakova, Krzysztof Zmudka, Rakesh Yadav, E. Bressollette, D. Nul, A. L. Astesiano, M. Urban, Abdulhay Albirini, C. T. Chin, F. Moulin, I. M. Coman, R. Watkin, J. Abanilla, J. Brønnum-Schou, J. Anusauskiene, P. Andrade Lotufo, Joseph G. Rogers, M. Bessen, P. C. Sartori, Paulo Roberto Ferreira Rossi, K. Atassi, H. V. Anderson, B. Klugherz, Bateshwar Prasad Singh, Mirza S. Baig, Z. Yusof, J. H. Geertman, A. Labroo, P. Nash, Freek W.A. Verheugt, Nancy J. Brown, M. A. Alcocer, A. Neskovic, L. Francek, Judith S. Hochman, A. Hoffmann, R. Dran, A. Podczeck-Schweighofer, Jeffry Katz, Josh Roberts, Roger E. McLendon, Ronald Rodriguez, T. Downes, A. Roth, L. E. Mayorga, Armagan Altun, José-Luis López-Sendón, M. Krotin, N. van der Merwe, O. Gigliotti, C. Park, G. Brigden, M. Kumbla, D. C G Basart, D. Erdogan, R. van Kranen, J. Beloscar, Johny Joseph, Pierluigi Tricoci, J. Marino, N. Mahon, S. Dani, I. Kovalskyy, Ioannis Nanas, V. Volkov, M. I. Edmilao, J. Kruells-Muench, F. Alamgir, R. Rinaldi, W. E. Mogrovejo, J. Mirat, C. Staniloae, S. Borromeo, H. Kozman, H. Zhang, Y. Zhou, S. Shurmur, A. Manari, M. A. Barrera, A. Vasylenko, D. Keedy, Paul A. Gurbel, Ali Oto, Charles R. Lambert, V. G. Ribeiro, A. Quintero, H. Joshi, L. Tang, J. Allan, C. S. Díaz, F. Carvalho Neuenschwander, Mircea Cintezǎ, M. Kokles, G. Piovaccari, Z. Kovacs, W. Li, C. Beauloye, E. J. Ramos, D. Bertolim Precoma, J. Burstein, G. Covelli, E. C. Zambrano, Assen Goudev, A. Tang, F. Henriquez, S. Tangsuntornwiwat, C. Kirma, GR Aycock, Kenneth W. Mahaffey, M. Ardnt, Jose C. Nicolau, O. Barbarash, E. K. Shin, P. Potapenko, T. Supryadkina, Asok Venkataraman, W. Mogrovejo, M. Acikel, R. Bohorquez, M. Syvänne, M. Chan, H. Mardikar, H. Berlin, O. Quintana, K. Heintz, J. M. Bastos, Guillermo Llamas Esperon, G. Aroney, J. Chen, Nancy H. Collins, C. Ahsan, G. Heins, F. Baer, V. Kondle, Nicholas Danchin, G. Shetty, Sergio Berti, Philip E. Aylward, James Cotton, G. S. Vallejo, Massimo Volpe, Z. Vasiljevic-Pokrajcic, C. Bugueño, Seung Woon Rha, S. Ilic, G. E. Stanciulescu, Z. Li, D. Nassiacos, R. Sciberras, S. Kuanprasert, Denilson Campos de Albuquerque, M. Pavlovic, Craig S. Barr, Mohammed R. Essop, John G. Canto, David T. Roberts, M. Ozdemir, Jacquelyn Miller, T. K. Ong, Sian E. Harding, V. Bose, J. Yoon, R. Syan, M. A. Paz, O. Maskon, Dennis V. Cokkinos, L. Kraus, Z. Masud, K. Amosova, M. Boyarkin, L. Mos, Dmitry Zamoryakhin, Arif Anis Khan, Jeffrey A. Breall, A. Gallino, Ivo Petrov, F. A. Alves da Cost, Saul Vizel, Hugo Vargas Filho, P. Kaewsuwanna, G. Antonelli, Chuen Den Tseng, I. Vakaliuk, J. Miklin, A. El Hawary, Ashok Jacob, D. Gumm, Kurt Huber, G. Pajes, N. Jathappa, Stanislaw Bartus, P. V. Lavhe, C. Romero, J. Balkin, T. Gould, R. Durgaprasad, Felipe Martinez, Henning Ebelt, A. Puri, D. K. Agarwal, E. E. Buyukoner, R. Mora Junior, P. Poliacik, A. Dande, X. Zhao, J. Floro, A. Bagriy, Yuliya Lokhnygina, M. Atieh, V. Batushkin, Valentin Markov, O. Karpenko, Peter Clemmensen, P. Castro, L. Paloscia, F. Florenzano, J. L. Accini, Tony Schibler, J. Arneja, W. Wu, B. Andruszkiewicz, Michael A. Morse, P. Vojtisek, D. Sadler, S. Frischwasser, M. Cayli, W N Leimbach, E. Flores, B. Wang, A Sosa Liprandi, Y. Michalaros, H. C. Finimundi, Raul D. Santos, N. Vijay, E. Magnus Ohman, Y. Karpenko, J. Sirotiakova, Z. Shogenov, D A Zateyshchikov, Eric P. Viergever, R. Bach, Gary S. Niess, D. C. Acosta, G. Piegari, J. B. Gupta, J. Shanes, E. Ronner, J. Arter, Claudio Cavallini, M. A. Hominal, V. Bugan, S. D. Varini, K. Nyman, B. G. Castillo, Sinan Aydoğdu, N. Novikova, D. Wang, P. Simpson, Y. Huang, Taral Patel, Gabriel Tatu-Chitoiu, D. Silva Junior, H. Theron, C. Alvarez, Anikó Ilona Nagy, T. Chua, P. Georgiev, D. Rittoo, G. De Luca, R. Blonder, Alberto Caccavo, D. Koganti, E. Manenti, N. Ghaisas, G. Letcher, D. Platogiannis, Arshed A. Quyyumi, J. Dy, Z. Ples, W. Kunz Sebba Barroso de Souza, Hamid Taheri, S. Kammoun, A. Salvioni, B. Stockins, K. Sutalo, J. C. Post, Merih Kutlu, Vijay K. Chopra, C. Mathis, Stephen M. Schwartz, Manish Jain, D. Coisne, A. Goudev, A. Dalby, João Morais, P. van Kalmthout, Andrzej Budaj, I. Dotani, L. Mircoli, R. Vicari, J. P. Herrman, M. Moran, G. Lupkovics, Alexander Parkhomenko, J. Heath, Andrew Moriarty, C. Pop, J. Y. Hwang, S. Kassam, R. Martingano, I. Nikolskaya, Z. Zheng, Johann S. de Bono, M. Izzo, R. Labonte, E. H. Forte, W. Moleerergpoom, Piera Angelica Merlini, D. Lee, W. Macias, G. Syan, S. Zhou, S. W. Kim, T. Duris, E. Shaoulian, Andreas U. Wali, Marco Antonio Mota Gomes, Pritibha Singh, M. Ovize, M. Del Core, W. Bowden, B. Xu, Ravi Bhagwat, C. Wongvipaporn, J. Vojacek, Steven Lindsay, F. McGrew, J. Gorny, J. D. Pappas, R. Vuyyuru, J. Chahin, Ashraf Reda, T. Lau, E. Conn, J. Meisner, S. Meymandi, A. D. Hrabar, M. Slanina, D. Jarasuniene, C. Lang, A. Vo, Christian Hamm, H. Gogia, Z. Yuan, T. Mathew, A. Van Dorpe, J. Kettner, M. Barbiero, Harvey D. White, L. Rudenko, V. Jain, M. Carter, David Erlinge, G. Ma, V. Sierkova, D. K. Kim, Steven O. Smith, R. K. Premchand, P. Jetty, J. Y. Hou, V. Simanenkov, T. Kaelsch, David P. Foley, A. Francis, Piotr Ponikowski, Ramón Corbalán, D. Connolly, J. Tuma, R. Zambahari, Miodrag Ostojic, R. Lamich, A. Rabelo Alves, V. Tseluyko, G. Moises Azize, L. Khaisheva, G. Pencheva, C. Ingram, J. Cooke, A. Prado, M. De Tollenaere, M. Kim, Alan Rees, Melanie B. Turner, Mark B. Abelson, H. L. Luciardi, L. Illyes, R. Sarma, L. Manriquez, J. A. Marin Neto, D. 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Subjects
Male, Prasugrel, Myocardial Infarction, Kaplan-Meier Estimate, Piperazines, Purinergic P2 Receptor Antagonists, Myocardial infarction, education.field_of_study, Cardiovascular diseases [NCEBP 14], Acute Coronary Syndrome, Aged, Angina, Unstable, Aspirin, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Middle Aged, Platelet Aggregation Inhibitors, Prasugrel Hydrochloride, Stroke, Thiophenes, Ticlopidine, Medicine (all), Hazard ratio, Clopidogrel, Acute Coronary Syndromes, General Medicine, Angina, Combination, Cardiology, medicine.drug, medicine.medical_specialty, Acute coronary syndrome, Population, Unstable, Drug Therapy, General & Internal Medicine, Internal medicine, medicine, cardiovascular diseases, education, Acute coronary syndromes, Revascularisation, Unstable angina, business.industry, medicine.disease, REVASCULARIZAÇÃO MIOCÁRDICA, business
Abstract

Item does not contain fulltext BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).

Published
2012

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