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(Stroke. 2007;38:789.)
© 2007 American Heart Association, Inc.

New Approaches to Clinical Trials in Neuroprotection: Introduction

New Approaches to Clinical Trials in Neuroprotection

Introduction

Mark P. Goldberg, MD

From the Hope Center for Neurological Disorders, Department of Neurology, Washington University School of Medicine, St. Louis, Mo.

Correspondence to Mark P. Goldberg, MD, Hope Center for Neurological Disorders, Department of Neurology, Campus Box 8111, Washington University School of Medicine, St. Louis, MO 63110 USA. E-mail goldbergm@neuro.wustl.edu

Key Words: clinical trial • stroke treatment, medical • neuroprotectors

An extract of the first 250 words of the full text is provided, because this article has no abstract.

In 10 years after the US Food and Drug Administration’s approval of intravenous tissue plasminogen activator (tPA) for acute ischemic stroke, tPA has had only a modest impact in the overall burden of disease. Current estimates suggest that about 2% to 8% of US ischemic stroke patients receive tPA,¹ and that continuing improvement of in-hospital care might not increase this proportion much beyond 20%.² There remains an urgent need for additional therapeutic approaches to acute ischemic stroke. Neuroprotective drug strategies offer the promise of limiting infarct tissue damage without increasing hemorrhage risk. Despite an extensive literature showing neuroprotective drug actions in reducing infarct size in rodent ischemia models, efficacy has not been confirmed in large multicenter clinical trials.^3,4 This situation is not unique to neuroprotective agents because many promising recanalization approaches have also failed. For example, a large trial of the glycoprotein IIb/IIIa inhibitor, abciximab, administered within 5 hours of symptom onset (or 3 hours after awakening with stroke) was recently terminated because of concerns of increased risk of intracranial hemorrhage in the treatment group.⁵ The defibrinogenating agent, ancrod, did not improve stroke outcome when administered within 6 hours of symptom onset (ESTAT study⁵) although it was found effective within 3 hours of onset in a previously reported trial with otherwise similar design (STAT study⁶). The parallel experience with clinical trials of tPA and ancrod serves to highlight the importance of early stroke recognition and rapid drug administration. No intravenously administered recanalization agent has been proven effective beyond . . . [Full Text of this Article]