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

This study has been terminated.
Information provided by:
Neurobiological Technologies Identifier:
First received: August 30, 2005
Last updated: December 21, 2009
Last verified: December 2009
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.

Condition Intervention Phase
Cerebral Ischemia
Brain Infarction
Drug: Ancrod (Viprinex)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Neurobiological Technologies:

Primary Outcome Measures:
  • Responder analysis based on Modified Rankin Scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 277
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ancrod (Viprinex)
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
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.
Drug: Placebo
0.6 mL/kg/hr

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00141011

  Show 100 Study Locations
Sponsors and Collaborators
Neurobiological Technologies
Study Director: Warren Wasiewski, M.D. Neurobiological Technologies
  More Information

Additional Information:
Responsible Party: Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc. Identifier: NCT00141011     History of Changes
Other Study ID Numbers: NTI-ASP-0502 
Study First Received: August 30, 2005
Last Updated: December 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurobiological Technologies:

Additional relevant MeSH terms:
Brain Infarction
Cerebral Infarction
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Fibrin Modulating Agents
Fibrinolytic Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016