Intravenous tPA for Acute Ischemic Stroke
Tissue Plasminogen Activator for Acute Ischemic Stroke
The National Institute of Neurological Disorders and Stroke rt-PA Study Group. NEJM. 1995;333(24):1581-1587
BACKGROUND
At the time of this study, there was no direct treatment to improve neurologic outcomes in acute ischemic stroke. Because the great majority of ischemic strokes are known to be the result of thrombotic occlusions, the authors speculated that early thrombolytic recanalization could reduce the degree of injury. Two smaller, open-label studies of intravenous (IV) tPA had suggested that early treatment within 180 minutes of stroke onset could reduce the risk of intracranial hemorrhage and maximize neurologic recovery.
OBJECTIVES
To assess the risks and benefits of IV tPA administered for treatment of acute ischemic stroke.
METHODS
Randomized, placebo-controlled trial conducted in two parts at eight centers across the United States from 1991 to 1994.
Patients
624 patients with acute ischemic stroke treated within 90 minutes (302 patients) or 180 minutes (322 patients) from stroke onset with defined time of onset, measurable deficit on National Institutes of Health stroke scale (NIHSS), and computed tomographic (CT) scan of the brain without evidence of intracranial hemorrhage. Average age was 66 to 69 years, and median NIHSS score was 14 to 15 in each group. Exclusion criteria included no stroke in preceding 3 months, major surgery within 14 days, systolic blood pressure >185 mm Hg, rapidly improving symptoms, or gastrointestinal hemorrhage within previous 21 days.

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