A study conducted by specialists from the University of Cincinnati (UC) shows that the combination of tissue plasminogen activator (tPA) with the antiplatelet drug eptifibatid dissolves blood clots safely and faster than tPA alone.

The results of the study, known as CLEAR-ER Stroke Trial, are published in the Journal of the American Heart Association.

The University of Cincinnati was the coordinating testing center, which involved nine medical centers (approximately 21 hospitals).

The standard treatment for acute ischemic stroke (characterized by the presence of obstructions for blood flow, usually bunches) is the intravenous delivery of tPA within three hours after a stroke. CLEAR-ER (combined approach to lysis using eptifibatide and recombinant tissue plasminogen activator (RT-PA) in acute ischemic stroke - enhanced regimen) is the second phase of clinical trials designed to determine the safety of the extended dose regimen of eptifibatide.

It will be used to conduct a third phase of clinical trials, where a wider range of patients will be used. As an antiplatelet drug, eptifibatide works intravenously with tPA to break up existing clots and prevent their formation, reducing platelet clumping.

"We were able to determine that eptifibatide can safely be combined with the average doses of tPA administered within three hours of the onset of symptoms and that there is every reason to start the third phase of the trial," says Opeolu Adeoye, MD, associate professor of medicine Emergencies and Neurosurgery at the Medical Center at the University of California.

Adeje co-authored the study with Arthur Pancioli, MD, Richard C.. Levy (Richard C. Levy) from the Department of Emergency Medicine in the UC. Both of them are members of the UC Institute of Neuroscience.

"We know that the combination of these two drugs dissolves clots faster and more fully than one tPA. The goal is to determine if we can use this combination to improve the recovery outcomes for an acute stroke, "says Panchioli.

From July 2009 to October 2012, the study involved 126 patients. Of these, 101 received tPA plus eptifibatide and 25 - only tPA. It was a double-blind, randomized trial; neither doctors nor patients knew whether, in addition to tPA, a drug or placebo. Researchers studied safety issues at specific endpoints, observing cases of intracerebral hemorrhage (ICH) and 90-day results using standardized measurement methods.

Of those given tPA plus eptifibatide, 50 patients (49.5%) showed good results. Of those who received only tPA, only 9 people showed good results (36%).

The safety of the two groups was at a comparable level in 36 hours, 7 days and 90 days from the beginning of the test.

The next step in clinical trials will be the expansion of the participants. The third phase is the last stage before the drugs are put on the market. It is designed to confirm its effectiveness, monitor the presence of side effects, compare it with other widely used treatment methods and collect information that will allow the safe use of the medicine.

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