This study will determine the dose of Retavase that can safely be combined with ReoPro in
treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and
Retavase are currently approved by the Food and Drug Administration to treat heart problems
caused by blockage of heart arteries. The only therapy approved by the Food and Drug
Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment is
effective only if begun within 3 hours of onset of the stroke, however, and most patients do
not get to the hospital early enough to benefit from it.
Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between
3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be
screened with a medical history and physical examination, blood tests, rating of neurological
deficits such as cognition deficits or problems walking that resulted from the stroke, and a
computed tomography (CT) scan of the head. CT involves the use of specialized X-rays to
obtain images of the brain. The patient lies on a table that is moved into a cylindrical
machine (the scanner) for the imaging study, which usually takes about 5 to 10 minutes.
All participants will receive 0.25 mg/kg of ReoPro (maximum dose of 30 mg). The drug is
infused into the vein over 12 hours. Some patients will also receive one of four doses of
Retavase, which may boost the effectiveness of ReoPro in opening the blocked blood vessel.
Retavase is given through a needle in the vein over 2 minutes. Patients will be monitored
daily until discharge from the hospital, or until day 5, whichever is earlier. Assessments
will include physical examinations, blood tests to examine factors involved in blood
clotting, and CT scans to evaluate both the response to treatment and drug side effects. They
will return for a follow-up examination and CT scan 30 days after treatment.
...
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)