Current practice versus willingness to enroll in clinical trials: paradox among vascular neurologists about treatment for acute ischemic stroke

Stroke. 2010 Sep;41(9):2038-43. doi: 10.1161/STROKEAHA.110.586511. Epub 2010 Jul 22.

Abstract

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.

MeSH terms

  • Clinical Trials as Topic*
  • Female
  • Fibrinolytic Agents / therapeutic use
  • Health Care Surveys
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Male
  • Stroke / drug therapy*
  • Thrombolytic Therapy / methods*
  • Time Factors
  • Tissue Plasminogen Activator / therapeutic use*
  • Treatment Outcome
  • United States

Substances

  • Fibrinolytic Agents
  • Tissue Plasminogen Activator