Current practice versus willingness to enroll in clinical trials: paradox among vascular neurologists about treatment for acute ischemic stroke
Department of Neurology
*Clinical Trials as Topic; Female; Fibrinolytic Agents; Health Care Surveys; *Health Knowledge, Attitudes, Practice; Humans; Male; Stroke; Thrombolytic Therapy; Time Factors; Tissue Plasminogen Activator; Treatment Outcome; United States
Neurology | Neuroscience and Neurobiology
BACKGROUND AND PURPOSE: Clinical trials are assessing the efficacy of fibrinolysis in extended time windows for acute ischemic stroke.
METHODS: An Internet-based survey was sent to 400 US vascular neurologists affiliated with a university to assess whether there are consensus opinions on how they treat patients beyond 3 hours from symptom onset and which patients they are willing to enroll into clinical trials of fibrinolysis for acute ischemic stroke.
RESULTS: We received 161 responses; 81% were male. Ninety-three percent of respondents treat patients with intravenous tissue plasminogen activator beyond 3 hours. More than 80% were treated beyond 3 hours with intra-arterial therapy (IAT). When asked if IAT improves stroke outcome, >50% selected the choice of "yes for middle cerebral artery and basilar occlusions" and only 2% selected the choice that "IAT does not improve outcome." Over half believe that imaging could be used to approximate the penumbra but with improvements to better identify salvageable tissue. Eighty-seven percent were willing to enroll patients into a placebo-controlled intravenous thrombolysis beyond 3 hours. For IAT trials, >80% would randomize beyond 3 hours with or without prior intravenous treatment.
CONCLUSIONS: Vascular neurologists have been treating acute ischemic stroke beyond 3 hours with intravenous tissue plasminogen activator even before the American Heart Association guidelines supported extending the therapeutic window. There is a paradox among the respondents willing to enroll patients into trials involving IAT given that a majority is offering IAT as part of their practice. These results suggest that clinical practice may impair enrollment into trials testing reperfusion therapies for acute ischemic stroke.
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Citation: Stroke. 2010 Sep;41(9):2038-43. Epub 2010 Jul 22. Link to article on publisher's site
El Khoury, Ramy; Fisher, Marc; and Savitz, Sean I., "Current practice versus willingness to enroll in clinical trials: paradox among vascular neurologists about treatment for acute ischemic stroke" (2010). Neurology Publications and Presentations. Paper 399.