Purpose: The primary purpose of these studies is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.
ASP-I- 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.
ASP-II- A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod (Viprinex™) in Subjects Beginning Treatment Within 6 Hours of the Onset of Acute, Ischemic Stroke.
Treatment: Ancrod (Viprinex™)
Phase: Phase III (650 Subjects are planned per study)
Study Director: Warren W. Wasiewski, M.D. F.A.A.P. Neurobiological Technologies, Inc. Tel: 201.941.8911
Study ID Number: NTI-ASP-0502 and NTI-ASP-0503 (ASP-I and ASP-II)
Eligibility: Inclusion Criteria:
Either Gender
Acute, Ischemic stroke with first symptoms within 6 hours of beginning treatment
≥18 Years old
Baseline NIHSS 5-25
Exclusion Criteria:
Intracranial, extravascular blood on CT
Hypertension (systolic >185; diastolic >105 mm Hg
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
If you are interested in participating in the ASP-I or ASP-II Clinical Trial, kindly fax the below completed forms to:
