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

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.

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, eptifibatidedelivered intravenouslyworks 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.


'/>"/>

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

Related medicine news :

1. Study Suggests Vaccine May Help Kids With Brain Cancer
2. Study reveals how cancer drug causes diabetic-like state
3. Coffee Drinking in Pregnancy Wont Lead to Sleepless Baby: Study
4. Lower GI problems plague many with rheumatoid arthritis, Mayo Clinic study finds
5. Veggies Like Broccoli, Cabbage May Help Fight Breast Cancer: Study
6. No Added Cancer Risk From Hip Replacement Materials: Study
7. Reported Decline in U.S. Pneumonia Deaths May Be False: Study
8. Early Study Finds Some Promise for Lung Cancer Vaccine
9. Narcissists Often Ace Job Interviews, Study Finds
10. Sexual objectification of female artists in music videos exists regardless of race, MU study finds
11. Soy may alleviate hot flashes in menopause, large-scale study finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users ... - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 ... Pro X . Simply select a ProHand generator and drag it above media or ...
(Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... Texas (PRWEB) , ... June 24, 2016 , ... ... International Conference and Scientific Sessions in Dallas that it will receive two significant ... of the grants came as PHA marked its 25th anniversary by recognizing patients, ...
(Date:6/24/2016)... Plano, TX (PRWEB) , ... June 24, 2016 , ... ... taking part in Genome magazine’s Code Talker Award, an essay contest in which patients ... for an award to be presented at the 2016 National Society of Genetic Counselors ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm ... sciences executive with extensive sequencing and genomics experience, as Vice President of North American ... Hill will be responsible for leading the sales team in the commercialization of the ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Calif. , June 23, 2016 Any dentist ... many challenges of the current process. Many of them do ... of the technical difficulties and high laboratory costs involved. And ... to offer it at such a high cost that the ... it. Dr. Parsa Zadeh , founder of ...
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... Ill. and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment ... Astellas Farma Brasil as the company,s second affiliate in Latin America . ... ... General Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology: