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

This study has been terminated.
(Futility)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141011
First Posted: September 1, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Neurobiological Technologies
  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
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

Further study details as provided by Neurobiological Technologies:

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

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


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

Additional Information:
Responsible Party: Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00141011     History of Changes
Other Study ID Numbers: NTI-ASP-0502
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: October 12, 2017
Last Verified: December 2009

Keywords provided by Neurobiological Technologies:
Stroke
Fibrinogen
Reperfusion
Thrombolysis

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