Status:
TERMINATED
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 :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00141011
Start Date
September 1 2005
End Date
December 1 2008
Last Update
December 23 2009
Active Locations (100)
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1
Mayo Clinic Hospital / Arizona
Phoenix, Arizona, United States, 85054
2
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
3
Loma Linda University School of Medicine
Loma Linda, California, United States, 92354
4
Santa Monica - UCLA Medical Center
Los Angeles, California, United States, 90024