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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ASP I (Ancrod Stroke Program) 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
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Stroke, Cerebral Ischemia, Brain Infarction

Intervention / Treatment
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* Drug: Ancrod (Viprinex)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous ancrod<br>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. | Drug: Ancrod (Viprinex)<br>* 0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours<br>|
| Placebo Comparator: Intravenous Placebo<br>Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level. | Drug: Placebo<br>* 0.6 mL/kg/hr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder analysis based on Modified Rankin Scale (mRS) |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Fibrinogen, Reperfusion, Thrombolysis