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.
DOI of Published Version
Stroke. 2010 Sep;41(9):2038-43. Epub 2010 Jul 22. Link to article on publisher's site
Stroke; a journal of cerebral circulation
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. 399.