ASP-II
Ancrod Stroke Program II: Ancrod for the Treatment of Acute, Ischemic Stroke
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Purpose:
To determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.
Interventions:
Ancrod
Fibrinogenolytic agent. Purified fraction of pit viper venom, cleaves fibrinogen.
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Location(s):
Multiple International Locations
Year Started:
2006
Year Finished:
2008
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Inclusion Criteria
Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment; baseline NIHSS > 5.
Exclusion Criteria
No intracranial, extravascular blood on CT; hypertension (systolic > 185; diastolic > 105); baseline fibrinogen level < 100 mg/dL; thrombocytopenia (< 100,000 / mm3); recent (< 3 days) or anticipated (< 5 days) use of a thrombolytic agent
Recent (< 14 days) or anticipated surgery.
Patient Involvement:
Patients receive a one-time, 2-3 hour infusion of ancrod or placebo within six hours of the initial symptom onset of their ischemic stroke, and are then followed for three months to collect information on their functional status.
Primary Outcome:
Modified Rankin Scale – responder analysis.
Secondary Outcome:
Barthel Index, NIH Stroke Scale Score.
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Source of Information:
ClinicalTrials.gov
Correspondence with trial coordinator.
Presented at the 2007 International Stroke Conference [February 2007].
Abstract from 2008 ISC.
Presented at 2008 International Stroke Conference (February 2008).
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Web Links and Publications:
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This information last updated on: 12/18/2008
Reviewed on: 12/18/2008.
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