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.

With prior approval by the FDA, an interim analysis for futility was performed when 500 subjects had been entered into the two parallel trials, NCT00141001 and NCT00300196. The analyses were reviewed by the data safety monitoring board, which recommended that both studies be terminated because of futility. This was done at a point where 650 subjects had been entered into both studies, combined, but analyses were conducted only on the initial 500 subjects. Results of the abbreviated analysis will be found with study NCT00141001 since that study contributed most of the subjects to the analysis.

• Stroke
• Cerebral Ischemia
• Brain Infarction

• Drug: Ancrod (Viprinex)
  0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
• Drug: Placebo
  0.6 mL/kg/hr

• Experimental: Intravenous ancrod
  Intravenous ancrod infused at a rate of 0.167 IU/kg/hr (0.6 mL/kg/hr) for 2 or 3 hours depending on the pretreatment fibrinogen level.
  Intervention: Drug: Ancrod (Viprinex)
• Placebo Comparator: Intravenous Placebo
  Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
  Intervention: Drug: Placebo

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