Title

Stroke Therapy Academic Industry Roundtable (STAIR) recommendations for extended window acute stroke therapy trials

UMMS Affiliation

Department of Neurology

Publication Date

2009-05-30

Document Type

Article

Subjects

Controlled Clinical Trials as Topic; Fibrinolytic Agents; *Health Planning Guidelines; Humans; Stroke; Thrombolytic Therapy; Time Factors; Tissue Plasminogen Activator

Disciplines

Neurology | Neuroscience and Neurobiology

Abstract

The Stroke Therapy Academic Industry Roundtable (STAIR) meetings focus on helping to advance the development of acute stroke therapies. Further extending the time window for acute stroke therapies is an important endeavor for increasing the number of stroke patients who might benefit from treatment. The STAIR group recommends that future extended time window trials initially should focus on selected patient groups most likely to respond to investigational therapies and that penumbral imaging is one tool that may identify such patients. The control group in these trials should receive best locally available medical care; if regulatory approval for intravenous (i.v.) tPA is extended to 4.5 hours, then tPA will become the most appropriate comparator in trials conducted within this time window. In future well-designed extended window clinical trials randomization is appropriate and should not be precluded by using unproven treatment with intraarterial (i.a.) thrombolysis or mechanical devices. For proof of concept, extended time window, phase II trials of i.v. thrombolysis, or mechanical devices in which early recanalization/reperfusion is the primary end point, rescue therapy/bailout treatment with i.a. thrombolysis or devices may be acceptable. Statistical considerations and definitions of successful recanalization/reperfusion are suggested for these trials.

DOI of Published Version

10.1161/STROKEAHA.109.552554

Source

Stroke. 2009 Jul;40(7):2594-600. Epub 2009 May 28. Link to article on publisher's site

Journal/Book/Conference Title

Stroke; a journal of cerebral circulation

Related Resources

Link to Article in PubMed

PubMed ID

19478212

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