"We're essentially building a toolbox," Dr. Broderick said. "One or both of these more interventional procedures may be useful and will be added to the treatment options. But they probably won't be the last.
The field is changing so rapidly, if new approaches arrive during the next five years, they could be included in the study."
Pilot studies at U.S. and Canadian centers found that the combined approach was encouraging enough compared with the standard tPA treatment to merit this new Phase III, which will be conducted at 50 centers in the United States and Canada, including 11 hospitals in the Greater Cincinnati/Northern Kentucky area.
In the late 1980s and mid-1990s, UC investigators played a leading role in developing and testing tPA as a treatment for ischemic stroke. They determined that if a stroke patient can be evaluated and treated with intravenous tPA within three hours, there was a good chance of full recovery.
However, although this represented a major step forward, intravenous tPA still does not open blocked brain arteries in many patients with larger strokes. So, since 1994, UC has initiated and coordinated three acute stroke trials that compared intravenous tPA administration with tPA delivery through a catheter.
The advantage of giving tPA intravenously, Dr. Broderick explained, is that it can be started quickly by any knowledgeable physician in any hospital with a CT (computerized tomography) scanner. Targeted injection of the clot-busting drug through a catheter, however, provides better opening of blocked arteries than intravenous tPA alone.
The new trial, funded by the NIH's National Institute of Neurological Disorders and Stroke, will involve physician and nurse investigators from four UC departments--neurology
Contact: Sheryl Hilton
University of Cincinnati