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Study shows combination stroke therapy safe and effective
Date:7/30/2013

Health

Says Pancioli: "We know that the combination of these two medications dissolves clots faster and more completely than tPA alone. Our goal is to determine if we can use this combination to improve the outcomes for acute stroke victims."

CLEAR-ER investigators enrolled 126 subjects from July 2009 to October 2012. Of those, 101 received tPA plus eptifibatide and 25 received tPA alone. As the trial was a double-blind, randomized study, neither patient nor doctor was aware if the substance administered in addition to tPA was a medication or a placebo.

Investigators examined safety at specified endpoints, watching for incidence of intracerebral hemorrhage (ICH), and 90-day outcomes using a standardized measurement tool. Of the subjects who were given tPA plus eptifibatide, 50 (49.5 percent) had what were classified as good outcomes. Those who received tPA alone had nine good outcomes (36 percent).

Safety between the two groups was shown to be comparable at 36-hour, seven-day and 90-day endpoints.

The potential next step in investigation of the enhanced regimen, a phase-3 clinical trial, would typically use a larger pool of subjects determined by data from the phase-2 trial. Phase-3 trials, the last step before marketing of a medication, typically confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow it to be used safely.


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Contact: Kathryn Cosse
kathryn.cosse@uc.edu
513-558-0207
University of Cincinnati Academic Health Center
Source:Eurekalert

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