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Pilot studies with recombinant tissue plasminogen activator (rtPA) for acute ischemic stroke suggested that early clot lysis can be performed with acceptable safety. If thrombolytic recanalization of occluded arteries can be performed before the infarction process has been completed, it may reduce the degree of ischemic injury to the brain. The North American perspective on thrombolytic therapy with rtPA in acute ischemic stroke is derived largely from these early pilot studies and the results of the phase III trial conducted by the National Institute of Neurological Disorders and Stroke(NINDS) rtPA Stroke Study group.1 On the basis of the NINDS study results, in mid-1996 the US Food and Drug Administration (FDA) advisory committee voted unanimously to recommend approval. The FDA approval followed rapidly for treatment of patients within 3 hours after onset of acute ischemic stroke. This article reviews the design and results of that study and its impact on current attitudes toward the management of patients with acute ischemic stroke in North America.
NINDS trial design. The NINDS trial was a phase III, multicenter, randomized, placebo-controlled, double-blind study conducted in eight centers in the United States. It was divided into two parts and enrolled a total of 624 patients in the combined study. The first part of the study was designed to assess whether patients receiving rtPA achieved significant early improvement in neurologic deficits compared to those receiving placebo. Early improvement was defined as complete resolution of the neurologic deficit or an improvement from baseline of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) 24 hours after the onset of stroke.
The second, pivotal part of the NINDS trial was an outcomes study that assessed whether treatment with rtPA reduced the chance of disability in those receiving rtPA compared with those receiving placebo measured …
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