Featured Research

from universities, journals, and other organizations

Combination stroke therapy safe and effective, study suggests

Date:
July 30, 2013
Source:
University of Cincinnati Academic Health Center
Summary:
The combination of the clot-busting drug tPA with an infusion of the antiplatelet drug eptifibatide dissolves blood clots safely and more quickly than tPA alone, a new study suggests, based on results from the phase-2 clinical trial, known as the CLEAR-ER Stroke Trial.

Arthur Pancioli, MD, Richard C. Levy chair for emergency medicine, instructs third-year medical student Kourtni Starkey in the emergency department at University Hospital.
Credit: University of Cincinnati

The combination of the clot-busting drug tPA with an infusion of the antiplatelet drug eptifibatide dissolves blood clots safely and more quickly than tPA alone, a study led by University of Cincinnati (UC) researchers has found.

Results from the study, known as the CLEAR-ER Stroke Trial, are published online in the journal Stroke: Journal of the American Heart Association. UC was the coordinating center for the trial, which included nine medical centers comprising 21 hospitals.

The CLEAR-ER Stroke Trial was sponsored by the National Institutes of Health's National Institute of Neurological Disorders and Stroke (NINDS) as a Specialized Programs of Translational Research in Acute Stroke (SPOTRIAS) project.

Standard treatment for acute ischemic stroke (characterized by an obstruction to the blood flow, typically a clot), is intravenous (IV) delivery of U.S. Food and Drug Administration-approved tissue plasminogen activator (tPA) within three hours of stroke onset.

The CLEAR-ER (Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke -- Enhanced Regimen) trial was a phase-2 clinical trial designed to determine the safety of an enhanced dosing regimen using eptifibatide and establish evidence for a phase-3 clinical trial, which would use a larger pool of subjects. As an antiplatelet medication, eptifibatide -- delivered intravenously -- works together with the tPA to break up the existing clot and prevents formation of additional clots by decreasing the clumping of blood platelets.

"Through our team's research efforts, we were able to determine that eptifibatide may be safely combined with medium-dose IV tPA administered within three hours of symptom onset and that a phase-3 clinical trial is warranted," says Opeolu Adeoye, MD, UC assistant professor of emergency medicine and neurosurgery and a neurointensivist at UC Medical Center.

Adeoye was co-principal investigator along with Arthur Pancioli, MD, professor and Richard C. Levy Chair for Emergency Medicine at UC. Both Adeoye and Pancioli are members of the UC Neuroscience Institute, one of four institutes affiliated with the UC College of Medicine and UC 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.

Adeoye also presented the study results at the American Heart Association/American Stroke Association's International Stroke Conference, held Feb. 5-8 in Honolulu.

Drugs for the CLEAR-ER trial were supplied by Genentech (tPA) and Merck (eptifibatide, marketed as Integrilin). Adeoye serves as a consultant to Genentech and is a member of its speakers' bureau. Pancioli reports no conflicts.


Story Source:

The above story is based on materials provided by University of Cincinnati Academic Health Center. Note: Materials may be edited for content and length.


Journal Reference:

  1. A. M. Pancioli, O. Adeoye, P. A. Schmit, J. Khoury, S. R. Levine, T. A. Tomsick, H. Sucharew, C. E. Brooks, T. J. Crocco, L. Gutmann, T. M. Hemmen, S. E. Kasner, D. Kleindorfer, W. A. Knight, S. Martini, J. S. McKinney, W. J. Meurer, B. C. Meyer, A. Schneider, P. A. Scott, S. Starkman, S. Warach, J. P. Broderick. Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke-Enhanced Regimen Stroke Trial. Stroke, 2013; DOI: 10.1161/%u200BSTROKEAHA.113.001059

Cite This Page:

University of Cincinnati Academic Health Center. "Combination stroke therapy safe and effective, study suggests." ScienceDaily. ScienceDaily, 30 July 2013. <www.sciencedaily.com/releases/2013/07/130730123255.htm>.
University of Cincinnati Academic Health Center. (2013, July 30). Combination stroke therapy safe and effective, study suggests. ScienceDaily. Retrieved October 2, 2014 from www.sciencedaily.com/releases/2013/07/130730123255.htm
University of Cincinnati Academic Health Center. "Combination stroke therapy safe and effective, study suggests." ScienceDaily. www.sciencedaily.com/releases/2013/07/130730123255.htm (accessed October 2, 2014).

Share This



More Health & Medicine News

Thursday, October 2, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Might Not Be Out Of Control In U.S., But Coverage Is

Ebola Might Not Be Out Of Control In U.S., But Coverage Is

Newsy (Oct. 2, 2014) Coverage of the lone Ebola patient discovered in Texas has U.S. media in a frenzy — but does the coverage match the reality? Video provided by Newsy
Powered by NewsLook.com
US Hunts Contacts of Ebola Patient, Including Children

US Hunts Contacts of Ebola Patient, Including Children

AFP (Oct. 2, 2014) Health officials in Texas on Wednesday scoured the Dallas area for people, including schoolchildren, who came in contact with a Liberian man who was diagnosed with Ebola in the United States. Duration: 00:55 Video provided by AFP
Powered by NewsLook.com
Study Says Losing Sense Of Smell Can Indicate Death

Study Says Losing Sense Of Smell Can Indicate Death

Newsy (Oct. 2, 2014) Researchers found elderly adults with a poor sense of smell are more likely to die within five years. Video provided by Newsy
Powered by NewsLook.com
Pregnancy Spacing Could Have Big Impact On Autism Risks

Pregnancy Spacing Could Have Big Impact On Autism Risks

Newsy (Oct. 1, 2014) A new study says children born less than one year and more than five years after a sibling can have an increased risk for autism. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins