Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
This study has been terminated.
(Futility)
Sponsor:
Neurobiological Technologies
Information provided by:
Neurobiological Technologies
ClinicalTrials.gov Identifier:
NCT00141011
First received: August 30, 2005
Last updated: December 21, 2009
Last verified: December 2009
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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 3 |
| 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 |
Resource links provided by NLM:
Further study details as provided by Neurobiological Technologies:
Primary Outcome Measures:
- Responder analysis based on Modified Rankin Scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141011
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Hide Study LocationsLocations
| United States, Arizona | |
| Mayo Clinic Hospital / Arizona | |
| Phoenix, Arizona, United States, 85054 | |
| United States, Arkansas | |
| Sparks Regional Medical Center | |
| Fort Smith, Arkansas, United States, 72901 | |
| United States, California | |
| Loma Linda University School of Medicine | |
| Loma Linda, California, United States, 92354 | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90024 | |
| Santa Monica - UCLA Medical Center | |
| Los Angeles, California, United States, 90024 | |
| Hoag Memorial Hospital | |
| Newport Beach, California, United States, 92658 | |
| The Neurology Center: Tri-City Medical Center | |
| Oceanside, California, United States, 92056 | |
| Shasta Regional Medical | |
| Redding, California, United States, 96001 | |
| United States, Connecticut | |
| Bridgeport Hospital | |
| Bridgeport, Connecticut, United States, 06610 | |
| United States, Florida | |
| Neurologic Consultants, P.A. | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Shands Jacksonville / University of Florida | |
| Jacksonville, Florida, United States, 32209 | |
| Ocala Neurodiagnostic Center | |
| Ocala, Florida, United States, 34471 | |
| Florida Hospital Neuroloscience Institute | |
| Orlando, Florida, United States, 32804 | |
| Fawcett Memorial Hospital | |
| Port Charlotte, Florida, United States, 33952 | |
| Peace River Regional Medical Center | |
| Port Charlotte, Florida, United States, 33952 | |
| Tallahassee Memorial Healthcare, Inc. | |
| Tallahassee, Florida, United States, 32303 | |
| United States, Hawaii | |
| The Queens Medical Center, Neuroscience Institute | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Mercy Hospital | |
| Chicago, Illinois, United States, 60616 | |
| United States, Indiana | |
| Elkhart Clinic, LLC - Neurology | |
| Elkhart, Indiana, United States, 46514 | |
| Fort Wayne Neurological Center | |
| Fort Wayne, Indiana, United States, 46804 | |
| Parkview Research Center | |
| Fort Wayne, Indiana, United States, 46805 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Massachusetts | |
| Baystate Medical Center | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| St. Mary's Duluth Clinic | |
| Duluth, Minnesota, United States, 55805 | |
| Minneapolis Clinic of Neurology | |
| Golden Valley, Minnesota, United States, 55422 | |
| United States, Montana | |
| Deaconess Billings Clinical Research Center | |
| Billings, Montana, United States, 59101 | |
| United States, New Jersey | |
| NJ Neuroscience Institute | |
| Edison, New Jersey, United States, 08818 | |
| Neurology Consultants Of Burlington County | |
| Lumberton, New Jersey, United States, 08048 | |
| UMDNJ / Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08901 | |
| Neurology Group of Bergen County | |
| Ridgewood, New Jersey, United States, 07450 | |
| Shore Neurology | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New York | |
| Kaleida Stroke Center | |
| Buffalo, New York, United States, 14209 | |
| United Health Services Hospitals | |
| Johnson City, New York, United States, 13790 | |
| Winthrop University Hospital | |
| Minneola, New York, United States, 11501 | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| Strong Memorial Hospital | |
| Rochester, New York, United States, 14642 | |
| Rochester General Hospital | |
| Rochester, New York, United States, 14621 | |
| United States, North Carolina | |
| Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28204 | |
| Lebauer Cardiovascular Research Foundation at Moses Cone Hospital | |
| Greensboro, North Carolina, United States, 27401 | |
| Clinical Research of Winston-Salem | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| The Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Medical University of Ohio | |
| Toledo, Ohio, United States, 43614 | |
| United States, Pennsylvania | |
| Northshore Clinical Associates | |
| Erie, Pennsylvania, United States, 16507 | |
| Westmoreland Neurology Associates, Inc. | |
| Greensburg, Pennsylvania, United States, 15601 | |
| United States, Rhode Island | |
| Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Beaufort Memorial Hospital | |
| Beaufort, South Carolina, United States, 34205 | |
| United States, Tennessee | |
| Methodist University Hospital | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Brackenridge Hospital | |
| Austin, Texas, United States, 78701 | |
| Seton Medical Center | |
| Austin, Texas, United States, 78705 | |
| Methodist Hospital / Neurological Institute | |
| Houston, Texas, United States, 77030 | |
| University of Texas Health Sciences Center | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23219 | |
| Neurological Consultants of Virginia Beach | |
| Virginia Beach, Virginia, United States, 23454 | |
| United States, Washington | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| St. Lukes Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Australia, New South Wales | |
| Gosford Hospital Department of Neurology | |
| Gosford, New South Wales, Australia, 2250 | |
| Australia, South Australia | |
| Flinders Medical Centre | |
| Bedford Park, South Australia, Australia, 5042 | |
| Australia, Victoria | |
| Box Hill Hospital | |
| Box Hill, Victoria, Australia | |
| National Stroke Research Institute | |
| Heidelberg Heights, Victoria, Australia, 3081 | |
| Canada, Alberta | |
| Grey Nuns Community Hospital | |
| Edmonton, Alberta, Canada, 1100 | |
| Canada, Newfoundland and Labrador | |
| Western Memorial Health Clinic | |
| Corner Brook, Newfoundland and Labrador, Canada, A2H 4B8 | |
| Canada, Ontario | |
| London Health Sciences Centre - University Hospital | |
| London, Ontario, Canada | |
| Trillum Health Centre | |
| Mississauga, Ontario, Canada, L5B1B8 | |
| Canada, Quebec | |
| Hospital Charles-Leymoyne | |
| Greenfield Park, Quebec, Canada, J4V2h1 | |
| Canada | |
| University of Alberta Hospital | |
| Edmonton, Canada, T6G2B7 | |
| Thunder Bay Regional Health Sciences Centre | |
| Thunder Bay, Canada, P7B7C7 | |
| Czech Republic | |
| St. Anne's Faculty Hospital | |
| Brno, Czech Republic, 65691 | |
| Faculty Hospital 1, The Clinic of Neurology | |
| Pilsen, Czech Republic, 30460 | |
| Netherlands | |
| St. Anna Hospital | |
| Geldrop, Netherlands, 5660 AB | |
| Poland | |
| University Clinical Hospital | |
| Warsaw, Poland, 02-097 | |
| Russian Federation | |
| City Hospital #31 | |
| Moscow, Russian Federation, 119415 | |
| Research Institute of Neurology RAMS | |
| Moscow, Russian Federation, 125367 | |
| Military Medical Akademy Dept of Neurology | |
| St. Petersburg, Russian Federation, 194044 | |
| South Africa | |
| St. Augustine's Hospital | |
| Berea, Durban, Kwazulu Natal, South Africa, 4001 | |
| Tiervlei Trial Centre | |
| Cape Town, South Africa, 7536 | |
| Vergelegen Medi-Clinic | |
| Somerset West, South Africa, 7130 | |
| Sunninghill Hospital | |
| Sunninghill, South Africa, 2157 | |
| Taiwan | |
| Changhua Christian Hospital, Chief Department of Neurology | |
| Changhua, Taiwan, 50022 | |
| Lo-Tung Pohai Hospital, Department of Neurology | |
| IIan, Taiwan, 265 | |
| Kaohsiung Chang-Gung, Memorial Hospital | |
| Kaohsiung, Taiwan, 83305 | |
| Chung-Ho Memorial Hospital Kaohsiung Medical University | |
| Kaohsiung, Taiwan, 807 | |
| China Medical University Hospital | |
| Taichung, Taiwan, 404 | |
| Chung Shan Medical Hospital | |
| Taichung, Taiwan, 402 | |
| Kuang-Tien General Hospital | |
| Taichung, Taiwan, 433 | |
| Taichung Veterans General Hospital, Section of Neurology | |
| Taichung, Taiwan, 407 | |
| Chi-Mei Medical Center | |
| Tainan, Taiwan, 710 | |
| Far Eastern Memorial Hospital | |
| Taipei, Taiwan, 220 | |
| Tri-Service General Hospital | |
| Taipei, Taiwan, 114 | |
| Shin-Kong WHS Memorial Hospital | |
| Taipei, Taiwan, 111 | |
| En Chu Kong Hospital | |
| Taipei, Taiwan, 23702 | |
| Cathay General Hospital Department of Neurology | |
| Taipei City, Taiwan, 11073 | |
| National Taiwan University Hospital | |
| Taipei City, Taiwan, 100 | |
| Chang-Gung Memorial Hospital, Linko Medical Center | |
| Taoyuang, Taiwan, 333 | |
| Chang-Gung Memorial Hospital Linko Medical Center | |
| Taoyuang, Taiwan, 333 | |
| United Kingdom | |
| University of Aberdeen, Polwarth Building, Institute of Medical Sciences, Dept. of Medicine & Theropeutics | |
| Aberdeen, United Kingdom, AB252ZD | |
| Institute of Neurological Sciences Southern General Hospital | |
| Glasgow, United Kingdom, G514TF | |
| Royal Victoria Infirmary - Clinical Research Center | |
| New Castle, United Kingdom | |
Sponsors and Collaborators
Neurobiological Technologies
Investigators
| Study Director: | Warren Wasiewski, M.D. | Neurobiological Technologies |
More Information
Additional Information:
No publications provided
| 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 |
Keywords provided by Neurobiological Technologies:
|
Stroke Fibrinogen Reperfusion Thrombolysis |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 13, 2013