Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
NCT ID: NCT00141011
Last Updated: 2009-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
277 participants
INTERVENTIONAL
2005-09-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Ancrod (Viprinex)
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
Intravenous Placebo
Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
Placebo
0.6 mL/kg/hr
Interventions
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Ancrod (Viprinex)
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
Placebo
0.6 mL/kg/hr
Eligibility Criteria
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Inclusion Criteria
* Baseline NIHSS \> 5
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Neurobiological Technologies
INDUSTRY
Responsible Party
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Neurobiological Technologies, Inc.
Principal Investigators
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Warren Wasiewski, M.D.
Role: STUDY_DIRECTOR
Neurobiological Technologies
Locations
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Mayo Clinic Hospital / Arizona
Phoenix, Arizona, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, United States
Loma Linda University School of Medicine
Loma Linda, California, United States
Santa Monica - UCLA Medical Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
The Neurology Center: Tri-City Medical Center
Oceanside, California, United States
Shasta Regional Medical
Redding, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, United States
Shands Jacksonville / University of Florida
Jacksonville, Florida, United States
Ocala Neurodiagnostic Center
Ocala, Florida, United States
Florida Hospital Neuroloscience Institute
Orlando, Florida, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, United States
Peace River Regional Medical Center
Port Charlotte, Florida, United States
Tallahassee Memorial Healthcare, Inc.
Tallahassee, Florida, United States
The Queens Medical Center, Neuroscience Institute
Honolulu, Hawaii, United States
Mercy Hospital
Chicago, Illinois, United States
Elkhart Clinic, LLC - Neurology
Elkhart, Indiana, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
St. Mary's Duluth Clinic
Duluth, Minnesota, United States
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
Deaconess Billings Clinical Research Center
Billings, Montana, United States
NJ Neuroscience Institute
Edison, New Jersey, United States
Neurology Consultants Of Burlington County
Lumberton, New Jersey, United States
UMDNJ / Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Neurology Group of Bergen County
Ridgewood, New Jersey, United States
Shore Neurology
Toms River, New Jersey, United States
Kaleida Stroke Center
Buffalo, New York, United States
United Health Services Hospitals
Johnson City, New York, United States
Winthrop University Hospital
Minneola, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Lebauer Cardiovascular Research Foundation at Moses Cone Hospital
Greensboro, North Carolina, United States
Clinical Research of Winston-Salem
Winston-Salem, North Carolina, United States
The Toledo Hospital
Toledo, Ohio, United States
Medical University of Ohio
Toledo, Ohio, United States
Northshore Clinical Associates
Erie, Pennsylvania, United States
Westmoreland Neurology Associates, Inc.
Greensburg, Pennsylvania, United States
Miriam Hospital
Providence, Rhode Island, United States
Beaufort Memorial Hospital
Beaufort, South Carolina, United States
Methodist University Hospital
Memphis, Tennessee, United States
Brackenridge Hospital
Austin, Texas, United States
Seton Medical Center
Austin, Texas, United States
Methodist Hospital / Neurological Institute
Houston, Texas, United States
University of Texas Health Sciences Center
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Neurological Consultants of Virginia Beach
Virginia Beach, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
St. Lukes Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Gosford Hospital Department of Neurology
Gosford, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
National Stroke Research Institute
Heidelberg Heights, Victoria, Australia
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Western Memorial Health Clinic
Corner Brook, Newfoundland and Labrador, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Trillum Health Centre
Mississauga, Ontario, Canada
Hospital Charles-Leymoyne
Greenfield Park, Quebec, Canada
University of Alberta Hospital
Edmonton, , Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, , Canada
St. Anne's Faculty Hospital
Brno, , Czechia
Faculty Hospital 1, The Clinic of Neurology
Pilsen, , Czechia
St. Anna Hospital
Geldrop, , Netherlands
University Clinical Hospital
Warsaw, , Poland
City Hospital #31
Moscow, , Russia
Research Institute of Neurology RAMS
Moscow, , Russia
Military Medical Akademy Dept of Neurology
Saint Petersburg, , Russia
St. Augustine's Hospital
Berea, Durban, KwaZulu-Natal, South Africa
Tiervlei Trial Centre
Cape Town, , South Africa
Vergelegen Medi-Clinic
Somerset West, , South Africa
Sunninghill Hospital
Sunninghill, , South Africa
Changhua Christian Hospital, Chief Department of Neurology
Changhua, , Taiwan
Lo-Tung Pohai Hospital, Department of Neurology
IIan, , Taiwan
Chung-Ho Memorial Hospital Kaohsiung Medical University
Kaohsiung City, , Taiwan
Kaohsiung Chang-Gung, Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital, Section of Neurology
Taichung, , Taiwan
Kuang-Tien General Hospital
Taichung, , Taiwan
Chi-Mei Medical Center
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Cathay General Hospital Department of Neurology
Taipei, , Taiwan
Shin-Kong WHS Memorial Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Far Eastern Memorial Hospital
Taipei, , Taiwan
En Chu Kong Hospital
Taipei, , Taiwan
Chang-Gung Memorial Hospital Linko Medical Center
Taoyuang, , Taiwan
Chang-Gung Memorial Hospital, Linko Medical Center
Taoyuang, , Taiwan
University of Aberdeen, Polwarth Building, Institute of Medical Sciences, Dept. of Medicine & Theropeutics
Aberdeen, , United Kingdom
Institute of Neurological Sciences Southern General Hospital
Glasgow, , United Kingdom
Royal Victoria Infirmary - Clinical Research Center
Newcastle, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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NTI-ASP-0502
Identifier Type: -
Identifier Source: org_study_id