Portal de Periódicos da CAPES

Artigo Acesso aberto Produção Nacional Revisado por pares

BIBTEX RIS

Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke–Enhanced Regimen Stroke Trial

2013; Lippincott Williams & Wilkins; Volume: 44; Issue: 9 Linguagem: Inglês

10.1161/strokeaha.113.001059

1524-4628

Arthur Pancioli, Opeolu Adeoye, Pamela Schmit, Jane Khoury, Steven R. Levine, Thomas A. Tomsick, Heidi Sucharew, Claudette E. Brooks, Todd J. Crocco, Laurie Gutmann, Thomas Hemmen, Scott E. Kasner, Dawn Kleindorfer, William A. Knight, Sharyl Martini, James S. McKinney, William J. Meurer, Brett C. Meyer, Alexander Schneider, Phillip Scott, Sidney Starkman, Steven Warach, Joseph P. Broderick, Arthur Pancioli, Opeolu Adeoye, Joseph P. Broderick, Pamela Schmit, Jane Khoury, Heidi Sucharew, Scott Janis, Thomas A. Tomsick, Claudette E. Brooks, Todd J. Crocco, Thomas Hemmen, Scott E. Kasner, James S. McKinney, William J. Meurer, Alex Schneider, Sidney Starkman, Steven Warach, Steven R. Levine, Claudia S. Moy, K.M.A. Welch, Gretchen E. Tietjen, William R. Clarke, Jordan Bonomo, Erin McDonough, Simona Ferioli, Felipe de los Rios De la Rosa, Sharyl Martini, Daniel Woo, Rachel Garvin, Dawn Kleindorfer, Pooja Khatri, Anna Gensic, Matthew L. Flaherty, Daniel Kanter, Brett Kissela, Brian Stettler, Jason Mackey, Rhonda Cadena, Shannon Kohake, Laura Heitsch, Samir Belagaje, Achala Vagal, John M. Hallenbeck, Richard Benson, Amie W. Hsia, Rakesh Jaitly, Lawrence L. Latour, John Lynch, José Luís Merino, Ravi S. Menon, Jason Freeman, Alejandro Magadán, Nandakumar Magaraja, Jennifer Jothen, Bonanle Famakin, Shlee Song, Alex Katcheves, Zurab Nadareishvili, C L Ritter, William G. Barsan, Devin Brown, Lewis B. Morgenstern, Robert Silbergleit, Venkatakrishna Rajajee, Lesli Rusche-Skolarus, J. R. Burke, Jeffrey J. Fletcher, Eric E. Adelman, Michael Ke Wang, Darin Zahuranec, Brett Cucchiara, Steven R. Messé, Christina Wilson, Koto Ishida, Michael Mullen, Jonathan M. Raser, Swaroop Pawar, David Rose, Neelofer Shafi, Igor Rybinnik, Michael McGavery, Lauren A. Beslow, Lauren Sansing, Latisha K. Ali, Hermelinda Abcede, Peter G. Adamczyk, William Buxton, Michael T. Froehler, Doojin Kim, David S. Liebeskind, Bruce Ovbiagele, Verna R. Porter, Venkatakrishna Rajajee, Neal Rao, Radoslav Raychev, Sarah Song, Jeffrey L. Saver, Matthew Tenser, Shamsha Velani, Anil Yallapragada, Brett C. Meyer, Any Guzik, Kiet Loc, Dawn Meyer, Gilda Tafreshi, Jessica Choe, Ajeet Sodhi, Patrick Delaney, Sean Evans, Omar Ghausi, Nhu Bruce, Will Neil, Brank Huisa, Andrew Stemer, Reid Taylor, Jeanette Larson, Seth Larson, Rodney Leacock, Subasisni Dash, Robert Eisenstein, Raffi Kapitanyan, Ugo Paolucci, Chirag Shah, Win Toe, John Brick, O. Ll. Lander, Hollynn Larrabee, Laurie Gutmann, Joseph Minardi, Allison Tadros, Roger Tillotson, Charles Whiteman, Debra J. Paulson, Rosanna Sikora, Christopher Cummings, John Burt Foster, Janice Carrozzella, Traci Doellman, Irene Ewing, Jamey Frasure, Gerald Goodall, Pamela Kimmel, Judith Spilker, Robert Tamer, Peggy Waymeyer, Joyce Zeigler, Lisa Davis, Saman Farsad, Teresa Morella, Allison M. Kade, Shirley Frederiksen, Mary Liz, Jean M. Luciano, Judy Guzy, Ileana Grunberg, Teresa Rzesiewicz, Karen Rapp, Tracy Nanney, Leslie E. Shell, Margaret Perkins, Cindy Benton, Robin Jones, Lynne C. Hampton, Claudine Cuento, Rachel Alosky, Stephanie A. Shepard, Michelle Moccio, Catherine Albrecht, Yaritza Rosario, D. Caputo, Stephen M. Davis, Patricia Altemus, Martha Power, Reyna VanGilder, Jay Sherman, Taura L. Barr,

Blood Coagulation and Thrombosis Mechanisms

In a previous study, 0.3 and 0.45 mg/kg of intravenous recombinant tissue plasminogen activator (rt-PA) were safe when combined with eptifibatide 75 mcg/kg bolus and a 2-hour infusion (0.75 mcg/kg per minute). The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke-Enhanced Regimen (CLEAR-ER) trial sought to determine the safety of a higher-dose regimen and to establish evidence for a phase III trial.CLEAR-ER was a multicenter, double-blind, randomized safety study. Ischemic stroke patients were randomized to 0.6 mg/kg rt-PA plus eptifibatide (135 mcg/kg bolus and a 2-hour infusion at 0.75 mcg/kg per minute) versus standard rt-PA (0.9 mg/kg). The primary safety end point was the incidence of symptomatic intracranial hemorrhage within 36 hours. The primary efficacy outcome measure was the modified Rankin Scale (mRS) score ≤1 or return to baseline mRS at 90 days. Analysis of the safety and efficacy outcomes was done with multiple logistic regression.Of 126 subjects, 101 received combination therapy, and 25 received standard rt-PA. Two (2%) patients in the combination group and 3 (12%) in the standard group had symptomatic intracranial hemorrhage (odds ratio, 0.15; 95% confidence interval, 0.01-1.40; P=0.053). At 90 days, 49.5% of the combination group had mRS ≤1 or return to baseline mRS versus 36.0% in the standard group (odds ratio, 1.74; 95% confidence interval, 0.70-4.31; P=0.23). After adjusting for age, baseline National Institutes of Health Stroke Scale, time to intravenous rt-PA, and baseline mRS, the odds ratio was 1.38 (95% confidence interval, 0.51-3.76; P=0.52).The combined regimen of intravenous rt-PA and eptifibatide studied in this trial was safe and provides evidence that a phase III trial is warranted to determine efficacy of the regimen.http://www.clinicaltrials.gov. Unique identifier: NCT00894803.