Future of neuroprotection for acute stroke: in the aftermath of the SAINT trials

UMMS Affiliation

Department of Neurology

Publication Date


Document Type



Acute Disease; Animals; Clinical Trials as Topic; Endpoint Determination; Humans; Neuroprotective Agents; Reperfusion Injury; Research Design; Stroke




The concept of neuroprotective therapy for acute ischemic stroke to salvage tissue at risk and improve functional outcome is based on sound scientific principles and extensive preclinical animal studies demonstrating efficacy. The failure of most neuroprotective drugs in clinical trials has been due to inadequate preclinical testing and flawed clinical development programs. The Stroke Therapy Academic Industry Roundtable (STAIR) group has outlined rational approaches to preclinical and clinical studies. The positive results from the first Stroke-Acute-Ischaemic-NXY-Treatment (SAINT-I) trial of the free-radical spin-trap drug, NXY-059, which followed many of the STAIR guidelines, reinvigorated enthusiasm in neuroprotection, but the SAINT-II trial did not replicate the positive effect on the same primary prespecified outcome measure. This has led to concerns about the future of neuroprotection as a therapeutic strategy for acute ischemic stroke. We discuss new suggestions to bridge the chasm between preclinical animal modeling and acute human stroke trials to potentially enhance the future assessment of novel neuroprotective drugs.

DOI of Published Version



Ann Neurol. 2007 May;61(5):396-402. Link to article on publisher's site

Journal/Book/Conference Title

Annals of neurology

Related Resources

Link to article in PubMed

PubMed ID


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