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| Sponsor: | Neurobiological Technologies |
|---|---|
| Information provided by: | Neurobiological Technologies |
| ClinicalTrials.gov Identifier: | NCT00300196 |
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 |
Biological: Ancrod (Viprinex) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Enrollment: | 311 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Intravenous ancrod: Experimental
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.
|
Biological: Ancrod (Viprinex)
0.167 IU/kg/hr IV for 2-3 hours
|
|
Intravenous Placebo: Placebo Comparator
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 94 Study Locations| Study Director: | Warren Wasiewski, M.D. | Neurobiological Technologies |
More Information
| Responsible Party: | Neurobiological Technologies, Inc. (no longer active) ( Warren W. Wasiewski, M.D. ) |
| Study ID Numbers: | NTI-ASP-0503 |
| Study First Received: | March 6, 2006 |
| Last Updated: | January 11, 2010 |
| ClinicalTrials.gov Identifier: | NCT00300196 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Stroke Fibrinogen Reperfusion Thrombolysis |
|
Ancrod Anticoagulants Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents Ischemia |
Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Fibrin Modulating Agents Necrosis Pathologic Processes Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction Infarction |
