Study shows combination stroke therapy safe and effective

July 30, 2013

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 (characterized by an obstruction to the blood flow, typically a clot), is intravenous (IV) delivery of U.S. Food and Drug Administration-approved (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 .

"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 and that a phase-3 clinical trial is warranted," says Opeolu Adeoye, MD, UC assistant professor of 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.

Explore further: Adding endovascular therapy to tPA didn't improve recovery after stroke

Related Stories

Adding endovascular therapy to tPA didn't improve recovery after stroke

February 8, 2013
Adding endovascular therapy to clot-busting therapy for stroke did not significantly improve stroke recovery at three months, according to a study presented in a special symposium at the American Stroke Association's International ...

tPA: Clot buster and brain protector

May 7, 2013
(Medical Xpress)—Ever since its introduction in the 1990s, the "clot-busting" drug tPA has been considered a "double-edged sword" for people experiencing a stroke. It can help restore blood flow to the brain, but it also ...

Use of clot busters for stroke increased from 2005 to 2009, but still low

June 2, 2011
The use of clot-busting drugs to treat acute ischemic stroke increased from 2005 through 2009 — but is still low, according to research reported in Stroke: Journal of the American Heart Association.

Clot-busting drug safe for stroke patients taking blood thinner

May 10, 2012
Acute ischemic stroke patients taking the blood thinner warfarin can be treated safely with the clot-busting drug tissue plasminogen activator (tPA), according to research presented at the American Heart Association's Quality ...

Delay in breaking up blood clots means worse stroke outcome

February 11, 2013
Every 30-minute delay in breaking up a blood clot from a stroke was associated with a 10 percent decrease in the probability of a good outcome, regardless of other factors such as stroke severity, according to late-breaking ...

Certified stroke centers more likely to give clot-busting drugs

March 26, 2013
Stroke patients are three times more likely to receive clot-busting medication if treated at a certified stroke center, according to a study in the Journal of the American Heart Association.

Recommended for you

Could aggressive blood pressure treatments lead to kidney damage?

July 18, 2017
Aggressive combination treatments for high blood pressure that are intended to protect the kidneys may actually be damaging the organs, new research from the University of Virginia School of Medicine suggests.

Quantifying effectiveness of treatment for irregular heartbeat

July 17, 2017
In a small proof-of-concept study, researchers at Johns Hopkins report a complex mathematical method to measure electrical communications within the heart can successfully predict the effectiveness of catheter ablation, the ...

Concerns over side effects of statins stopping stroke survivors taking medication

July 17, 2017
Negative media coverage of the side effects associated with taking statins, and patients' own experiences of taking the drugs, are among the reasons cited by stroke survivors and their carers for stopping taking potentially ...

Study discovers anticoagulant drugs are being prescribed against safety advice

July 17, 2017
A study by researchers at the University of Birmingham has shown that GPs are prescribing anticoagulants to patients with an irregular heartbeat against official safety advice.

Protein may protect against heart attack

July 14, 2017
DDK3 could be used as a new therapy to stop the build-up of fatty material inside the arteries

Heart study finds faulty link between biomarkers and clinical outcomes

July 14, 2017
Surrogate endpoints (biomarkers), which are routinely used in clinical research to test new drugs, should not be trusted as the ultimate measure to approve new health interventions in cardiovascular medicine, according to ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.