ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurobiological Technologies
• Treatments: Ancrod

Criteria

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