ASP I
Ancrod (Viprinex™) for the Treatment of Acute Ischemic Stroke
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Status:
This study has been terminated.
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:
2005
Year Finished:
2009
Design:
Treatment, randomized, double-blind, placebo control, parallel assignment, safety/efficacy, multi-center international 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; or 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
Presented at the 2006 International Stroke Conference [February 2006].
Presented at the 2008 International Stroke Conference [February 2008].
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Web Links and Publications:
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This information last updated on: 1/15/2009
Reviewed on: 01/15/2009.
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