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| Sponsor: | Neurobiological Technologies |
|---|---|
| Information provided by: | Neurobiological Technologies |
| ClinicalTrials.gov Identifier: | NCT00141011 |
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 |
Drug: Ancrod (Viprinex) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 277 |
| Study Start Date: | September 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Ancrod (Viprinex)
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
|
|
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.
|
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 100 Study Locations| Study Director: | Warren Wasiewski, M.D. | Neurobiological Technologies |
More Information
| Responsible Party: | Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT00141011 History of Changes |
| Other Study ID Numbers: | NTI-ASP-0502 |
| Study First Received: | August 30, 2005 |
| Last Updated: | December 21, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Stroke Fibrinogen Reperfusion Thrombolysis |
|
Cerebral Infarction Brain Ischemia Infarction Ischemia Stroke Brain Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Necrosis Ancrod Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
