The primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.
Official Title
Study of Acute Viprinex for Emergency Stroke: A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod (Viprinex) in Subjects Beginning Treatment Within 6 Hours of the Onset of Acute, Ischemic Stroke
Conditions
Stroke, Cerebral Ischemia, Brain Infarction
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Further Details
- Primary Outcome Measures: Barthel Index
- Secondary Outcome Measures: Modified Rankin Score
Study Start
September 2005
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
Inclusion Criteria:
- Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
- Baseline NIHSS 5-25
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
Total Enrolment
650
Contact Details
Gosford Hospital Department of Neurology, Gosford, New South Wales, 2250, Australia; Recruiting
- Margaret Webb 61243203932 mmwebb@nsccahs.health.nsw.gov.au
Gold Coast Hospital, Southport, Queensland, 4215, Australia; Recruiting
- Grahame Creamer 610755197889 grahame_creamer@health.qld.gov
Box Hill Hospital, Box Hill, Victoria, Australia; Recruiting
- Zofia Ross
National Stroke Research Institute, Heidelberg Heights, Victoria, 3081, Australia; Recruiting
- Ros Kelly +61-3-9496-2607 rkelly@nstri.org.au
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