Review, Historical Context, and Clarifications of the NINDS rt-PA Stroke Trials Exclusion Criteria

Clinical Trials Thursday, July 18th, 2013

STROKEAHA:  7/11/13

 

Background and Purpose—Since Food and Drug Administration approval of intravenous tissue-type plasminogen activator (tPA) for treatment of acute ischemic stroke in 1996, it has become clear that several criteria used for exclusion from therapy were not based on actual data or operationally defined for use in clinical practice. All eligibility criteria from the National Institute of Neurological Disorders and Stroke (NINDS) recombinant tPA Stroke Study were adopted within the alteplase package insert as contraindications/warnings. Many clinicians have expressed the need for clarification and better definition of these treatment criteria. Read More

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