Researchers at the University of Cincinnati (UC) emergency medicine and neurology departments have been awarded $2.3 million to begin the second phase of a national stroke study.
The five-year study, called CLEAR-ER, looks at the combination of two drugs to treat acute ischemic stroke, which occurs when an artery to the brain is blocked by a blood clot: rt-PA, which dissolves clots, and eptifibatide, which blocks clotting receptors. Current emergency protocol treats stroke with only one drug, rt-PA.
“What we’ve been attempting to do is fine tune the combination with the idea of maintaining safety and increasing efficacy,” says Arthur Pancioli, MD, vice chair of the emergency medicine department and the study’s principal investigator.
“Time is unbelievably important when it comes to acute stroke; from the time the symptoms start we have only three hours to begin rt-PA,” says Pancioli, “and a clot has many, many components. We know that rt-PA dissolves one aspect of a clot and we know that the combination of the two drugs dissolves clot faster and more completely. The question we must answer is: Can we do it safely and ultimately improve outcomes with this strategy?”
The CLEAR-ER study is an enhanced version of an initial, five-year UC study called CLEAR, for which Pancioli was also the principal investigator. CLEAR ended in 2008 and found that combining the two drugs in low doses was safe and warranted further investigation. The results of this study are currently available online in Stroke, a journal on cerebrovascular diseases published by the American Heart Association.
“We demonstrated that the combination was at least as safe at rt-PA alone,” says Pancioli. With CLEAR-ER, he says, the number of study participants will increase from 94 to126 and the combined dosages will increase.
The study will take place at seven emergency centers across the country, including Cincinnati. Potential candidates for the local trial will be seen by physicians from the Greater Cincinnati/Northern Kentucky Stroke Team at local emergency departments.
Both studies are funded by the National Institutes of Health under the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS) grant.
Joseph Broderick, MD, chair of the neurology department and principal investigator of the SPOTRIAS program at UC, notes, “The University of Cincinnati was the first national SPOTRIAS center funded by the NIH and we continue to be world leaders in developing new and innovative treatments for stroke patients.”
SPORTRIAS is a national network of stroke centers that perform early phase clinical projects, share data, train new stroke fellows and promote new approaches to therapy for acute stroke.