http://stroke.ahajournals.org/content/48/9/2632?etoc=
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Stroke
risk and poststroke disability have steadily decreased in the United
States over the past 2 decades because of improved prevention and access
to reperfusion therapies for acute ischemic stroke, such as tPA
(tissue-type plasminogen activator; alteplase) and endovascular
thrombectomy. Despite the efficacy and safety of thrombolysis and
thrombectomy, not all patients who receive the treatment improve to
full, independent recovery, and most patients are ineligible for
treatment. Additionally, there are no efficacious treatments to improve
long-term outcomes for patients after the acute phase of ischemic stroke
or to reduce brain injury induced by acute intracerebral hemorrhage.
Therefore, development of new therapies for both acute and chronic
stroke is sorely needed.
Stroke occurs because of a
variety of vascular pathologies and injury mechanisms, some of which are
difficult to model in animals. With the exception of reperfusion
therapy, preclinical research end points do not generally reflect
clinical outcomes. Pharmacodynamics, pharmacokinetics, and target
engagement in the human brain need to be further developed and optimized
for stroke interventions so that drug level in brain tissue, time to
initiation, and duration of treatment can be accurately measured in
clinical trials. Many variables, such as heterogeneity of vascular
pathologies, patient demographics, and a host of comorbid conditions, as
well as the lack of validated biomarkers to stratify patient
populations, limit the ability of typical stroke clinical trials to
detect a treatment effect.
To address these gaps, the
National Institute of Neurological Disorders and Stroke organized and
sponsored the workshop Translational Stroke Research: Vision and
Opportunities, which was held in Bethesda, Maryland, on November 1 to 2,
2016. The workshop gathered over 180 registered participants from
academia, industry, the Food and Drug Administration, and other public
and private funding agencies. …
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