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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Neurobiological Technologies
- Enrollment
- 277
- Locations
- 100
- Primary Endpoint
- Responder analysis based on Modified Rankin Scale (mRS)
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- 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
Arms & Interventions
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: Placebo (Drug)
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: Ancrod (Viprinex) (Drug)
Outcomes
Primary Outcomes
Responder analysis based on Modified Rankin Scale (mRS)
Time Frame: 90 days
Secondary Outcomes
- National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx(90 days)