ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

This study has been terminated.
(Futility)
Sponsor:
Information provided by:
Neurobiological Technologies
ClinicalTrials.gov Identifier:
NCT00300196
First received: March 6, 2006
Last updated: January 11, 2010
Last verified: January 2010

March 6, 2006
January 11, 2010
March 2006
December 2008   (final data collection date for primary outcome measure)
Modified Rankin Score - responder analysis [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Modified Rankin Score
Complete list of historical versions of study NCT00300196 on ClinicalTrials.gov Archive Site
Barthel Index, NIHSS [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Barthel Index
Not Provided
Not Provided
 
ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
ASP II (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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Cerebral Ischemia
  • Brain Infarction
  • Biological: Ancrod (Viprinex)
    0.167 IU/kg/hr IV for 2-3 hours
  • Drug: Placebo
    0.6 mL/kg/hr
  • 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.
    Intervention: Biological: Ancrod (Viprinex)
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
311
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Czech Republic,   Israel,   New Zealand,   Poland,   Russian Federation,   Slovakia,   South Africa,   Switzerland
 
NCT00300196
NTI-ASP-0503
Yes
Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc. (no longer active)
Neurobiological Technologies
Not Provided
Study Director: Warren Wasiewski, M.D. Neurobiological Technologies
Neurobiological Technologies
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP