학술논문
Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke–Enhanced Regimen Stroke Trial
Document Type
Academic Journal
Author
Pancioli, Arthur M.; Adeoye, Opeolu; Schmit, Pamela A.; Khoury, Jane; Levine, Steven R.; Tomsick, Thomas A.; Sucharew, Heidi; Brooks, Claudette E.; Crocco, Todd J.; Gutmann, Laurie; Hemmen, Thomas M.; Kasner, Scott E.; Kleindorfer, Dawn; Knight, William A.; Martini, Sharyl; McKinney, James S.; Meurer, William J.; Meyer, Brett C.; Schneider, Alexander; Scott, Phillip A.; Starkman, Sidney; Warach, Steven; Broderick, Joseph P.; Pancioli, Arthur M.; Adeoye, Opeolu; Broderick, Joseph; Schmit, Pamela A.; Khoury, Jane; Sucharew, Heidi; Janis, Scott; Tomsick, Thomas; Brooks, Claudette E.; Crocco, Todd; Hemmen, Thomas; Kasner, Scott E.; McKinney, James S.; Meurer, William J.; Schneider, Alex; Starkman, Sidney; Warach, Steven; Levine, Steven; Moy, Claudia; Welch, K. Michael; Tietjen, Gretchen; Clarke, William R.; Bonomo, Jordan; McDonough, Erin; Ferioli, Simona; De la Rosa, Felipe de los Rios; Martini, Sharyl; Woo, Daniel; Garvin, Rachel; Kleindorfer, Dawn; Khatri, Pooja; Gensic, Anna; Flaherty, Matthew; Kanter, Daniel; Kissela, Brett; Stettler, Brian; Mackey, Jason; Cadena, Rhonda; Kohake, Shannon; Heitsch, Laura; Belagaje, Samir; Vagal, Achala; Hallenbeck, John; Benson, Richard; Hsia, Amie; Jaitly, Rakesh; Latour, Lawrence; Lynch, John; Merino, Jose; Menon, Ravi; Freeman, Jason; Magadan, Alejandro; Magaraja, Nandakumar; Jothen, Jennifer; Famakin, Bonanle; Song, Shlee; Katcheves, Alex; Nadareishvili, Zurab; Ritter, Carsen; Barsan, William; Brown, Devin; Morgenstern, Lewis; Silbergleit, Robert; Rajajee, Venkatakrishna; Rusche-Skolarus, Lesli; Burke, Jim; Fletcher, Jeffrey; Adelman, Eric; Wang, Michael; Zahuranec, Darin; Cucchiara, Brett; Messe, Steven; Wilson, Christina; Ishida, Koto; Mullen, Michael; Raser, Jonathan; Pawar, Swaroop; Rose, David; Shafi, Neelofer; Rybinnik, Igor; McGavery, Michael; Beslow, Lauren; Sansing, Lauren; Ali, Latisha; Abcede, Hermelinda; Adamczyk, Peter; Buxton, William; Froehler, Michael; Kim, Doojin; Liebeskind, David; Ovbiagele, Bruce; Porter, Verna; Rajajee, Venkatakrishna; Rao, Neal; Raychev, Radoslav; Song, Sarah; Saver, Jeffrey; Tenser, Matthew; Velani, Shamsha; Yallapragada, Anil; Meyer, Brett; Guzik, Any; Loc, Kiet; Meyer, Dawn; Tafreshi, Gilda; Choe, Jessica; Sodhi, Ajeet; Delaney, Patrick; Evans, Sean; Ghausi, Omar A.; Bruce, Nhu; Neil, Will; Huisa, Brank; Stemer, Andrew; Taylor, Reid; Larson, Jeanette; Larson, Seth; Leacock, Rodney; Dash, Subasisni; Eisenstein, Robert; Kapitanyan, Raffi; Paolucci, Ugo; Shah, Chirag; Toe, Win; Brick, John; Lander, Owen; Larrabee, Hollynn; Gutmann, Laurie; Minardi, Joseph; Tadros, Allison; Tillotson, Roger; Whiteman, Charles; Paulson, Debra; Sikora, Rosanna; Cummings, Christopher; Foster, John; Carrozzella, Janice; Doellman, Traci; Ewing, Irene; Frasure, Jamey; Goodall, Emily; Kimmel, Pamela; Spilker, Judith; Tamer, Robert; Waymeyer, Peggy; Zeigler, Joyce; Davis, Lisa; Farsad, Saman; Morella, Teresa; Kade, Allison; Frederiksen, Shirley; Liz, Mary; Luciano, Jean; Guzy, Judy; Grunberg, Ileana; Rzesiewicz, Teresa; Rapp, Karen; Nanney, Tracy; Shell, Leslie; Perkins, Margaret; Benton, Cindy; Jones, Robin; Hampton, Lynne; Cuento, Claudine; Alosky, Rachel; Shepard, Stephanie; Moccio, Michelle; Albrecht, Catherine; Rosario, Yaritza; Caputo, Deborah; Davis, Stephen; Altemus, Patricia; Power, Martha; VanGilder, Reyna; Sherman, Jay; Barr, Taura
Source
Stroke. Sep 01, 2013 44(9):2381-2387
Subject
Language
English
ISSN
0039-2499
Abstract
BACKGROUND AND PURPOSE—: 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. METHODS—: 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. RESULTS—: 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). CONCLUSIONS—: 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. CLINICAL TRIAL REGISTRATION—: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00894803.