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Trial record 1 of 32 for:    VIPRINEX
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Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT00141011
Recruitment Status : Terminated (Futility)
First Posted : September 1, 2005
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:
Neurobiological Technologies

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Cerebral Ischemia Brain Infarction Drug: Ancrod (Viprinex) Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Responder analysis based on Modified Rankin Scale (mRS) [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141011


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

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Responsible Party: Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00141011    
Other Study ID Numbers: NTI-ASP-0502
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009
Keywords provided by Neurobiological Technologies:
Stroke
Fibrinogen
Reperfusion
Thrombolysis
Additional relevant MeSH terms:
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Ancrod
Stroke
Brain Ischemia
Cerebral Infarction
Brain Infarction
Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action