Status:
TERMINATED
ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
Lead Sponsor:
Neurobiological Technologies
Conditions:
Stroke
Cerebral Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
- Baseline NIHSS \> 5
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT00300196
Start Date
March 1 2006
End Date
December 1 2008
Last Update
January 12 2010
Active Locations (94)
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1
Enloe Medical Center
Chico, California, United States, 95973
2
UCSF-Fresno
Fresno, California, United States, 93701
3
Sherry Braheny MD - A Prof. Corporation
La Mesa, California, United States, 91942
4
Mercy General Hospital
Sacramento, California, United States, 95825