Ancrod (Viprinex) for the Treatment of Acute, Ischemic Stroke

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