Journal article
Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke-Enhanced Regimen Stroke Trial
Stroke (1970), Vol.44(9), pp.2381-2387
2013
DOI: 10.1161/STROKEAHA.113.001059
PMCID: PMC3970761
PMID: 23887841
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.
Details
- Title: Subtitle
- Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke-Enhanced Regimen Stroke Trial
- Creators
- Arthur M PANCIOLI - University of Cincinnati Neuroscience Institute, Cincinnati, OH, United StatesOpeolu ADEOYE - University of Cincinnati Neuroscience Institute, Cincinnati, OH, United StatesThomas M HEMMEN - Department of Neurosciences, University of California San Diego, San Diego, CA, United StatesScott E KASNER - Department of Neurology, University of Pennsylvania, Philadelphia, PA, United StatesDawn KLEINDORFER - University of Cincinnati Neuroscience Institute, Cincinnati, OH, United StatesWilliam A KNIGHT - University of Cincinnati Neuroscience Institute, Cincinnati, OH, United StatesSharyl MARTINI - University of Cincinnati Neuroscience Institute, Cincinnati, OH, United StatesJames S MCKINNEY - Department of Neurology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ, United StatesWilliam J MEURER - Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, United StatesBrett C MEYER - Department of Neurosciences, University of California San Diego, San Diego, CA, United StatesAlexander SCHNEIDER - Mission Hospital, Asheville, NC, United StatesPhillip A SCOTT - Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, United StatesPamela A SCHMIT - University of Cincinnati Neuroscience Institute, Cincinnati, OH, United StatesSidney STARKMAN - Departments of Emergency Medicine and Neurology, University of California Los Angeles, Los Angeles, CA, United StatesSteven WARACH - National Institute of Neurological Disorders and Stroke, Bethesda, MD, United StatesJoseph P BRODERICK - University of Cincinnati Neuroscience Institute, Cincinnati, OH, United StatesJane KHOURY - Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United StatesSteven R LEVINE - Department of Neurology and Emergency Medicine, The State University of New York (SUNY) Downstate Stroke Center and Medical Center, and King County Hospital Center, Brooklyn, NY, United StatesThomas A TOMSICK - University of Cincinnati Neuroscience Institute, Cincinnati, OH, United StatesHeidi SUCHAREW - Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United StatesClaudette E BROOKS - Department of Neurology, West Virginia University, Morgantown, WV, United StatesTodd J CROCCO - Department of Emergency Medicine, West Virginia University, Morgantown, WV, United StatesLaurie GUTMANN - Department of Neurology, West Virginia University, Morgantown, WV, United States
- Resource Type
- Journal article
- Publication Details
- Stroke (1970), Vol.44(9), pp.2381-2387
- Publisher
- Lippincott Williams & Wilkins; Hagerstown, MD
- DOI
- 10.1161/STROKEAHA.113.001059
- PMID
- 23887841
- PMCID
- PMC3970761
- ISSN
- 0039-2499
- eISSN
- 1524-4628
- Language
- English
- Date published
- 2013
- Academic Unit
- Neurology
- Record Identifier
- 9984013277802771
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