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

This study has been terminated.
(Futility)
Sponsor:
Information provided by:
Neurobiological Technologies
ClinicalTrials.gov Identifier:
NCT00141011
First received: August 30, 2005
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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
Stroke
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

Resource links provided by NLM:

Drug Information available for: Fibrinogen
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141011

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc.
ClinicalTrials.gov 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:
Stroke
Fibrinogen
Reperfusion
Thrombolysis

Additional relevant MeSH terms:
Cerebral Infarction
Brain Ischemia
Infarction
Ischemia
Stroke
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Pathologic Processes
Necrosis
Ancrod
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013