CHAPTER 53 tPA for Acute Ischemic Stroke: The NINDS Trial

Tissue Plasminogen Activator for Acute Ischemic Stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group

N Engl J Med. 1995;333(24):1581–1587

BACKGROUND

Ischemic stroke affects over 400,000 people in the United States annually. At the time of this study, there was no direct treatment to reduce neurologic injury. Early trials of thrombolytic therapy showed intracerebral hemorrhage to be a major complication and the magnitude of clinical benefit with respect to mortality was not well-known. However, prior trials suggested that use within 180 minutes was relatively safe and warranted a wider and more rigorous study.

OBJECTIVES

To determine if IV tPA has improved clinical outcome if administered within 3 hours of onset of stroke symptoms.

METHODS

Randomized double-blinded trial conducted in eight centers around the United States between 1991 and 1994. The study was divided into two parts, one to detect an early effect (<24 hours) and the second to detect a late effect (3 months).

Participants

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