Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
- Conditions
- Brain InfarctionStrokeCerebral Ischemia
- Interventions
- Drug: Placebo
- Registration Number
- NCT00141011
- Lead Sponsor
- Neurobiological Technologies
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 277
- Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
- Baseline NIHSS > 5
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous ancrod Ancrod (Viprinex) 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. Intravenous Placebo Placebo Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
- Primary Outcome Measures
Name Time Method Responder analysis based on Modified Rankin Scale (mRS) 90 days
- Secondary Outcome Measures
Name Time Method National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx 90 days
Trial Locations
- Locations (100)
Loma Linda University School of Medicine
🇺🇸Loma Linda, California, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
Elkhart Clinic, LLC - Neurology
🇺🇸Elkhart, Indiana, United States
Lebauer Cardiovascular Research Foundation at Moses Cone Hospital
🇺🇸Greensboro, North Carolina, United States
Mercy Hospital
🇺🇸Chicago, Illinois, United States
Methodist Hospital / Neurological Institute
🇺🇸Houston, Texas, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
St. Anne's Faculty Hospital
🇨🇿Brno, Czech Republic
St. Augustine's Hospital
🇿🇦Berea, Durban, Kwazulu Natal, South Africa
Tiervlei Trial Centre
🇿🇦Cape Town, South Africa
Shands Jacksonville / University of Florida
🇺🇸Jacksonville, Florida, United States
Neurologic Consultants, P.A.
🇺🇸Fort Lauderdale, Florida, United States
Peace River Regional Medical Center
🇺🇸Port Charlotte, Florida, United States
Fawcett Memorial Hospital
🇺🇸Port Charlotte, Florida, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
UMDNJ / Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Deaconess Billings Clinical Research Center
🇺🇸Billings, Montana, United States
National Stroke Research Institute
🇦🇺Heidelberg Heights, Victoria, Australia
China Medical University Hospital
🇨🇳Taichung, Taiwan
London Health Sciences Centre - University Hospital
🇨🇦London, Ontario, Canada
St. Anna Hospital
🇳🇱Geldrop, Netherlands
Changhua Christian Hospital, Chief Department of Neurology
🇨🇳Changhua, Taiwan
Chung Shan Medical Hospital
🇨🇳Taichung, Taiwan
En Chu Kong Hospital
🇨🇳Taipei, Taiwan
University of Texas Health Sciences Center
🇺🇸San Antonio, Texas, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Minneapolis Clinic of Neurology
🇺🇸Golden Valley, Minnesota, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Mayo Clinic Hospital / Arizona
🇺🇸Phoenix, Arizona, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Sparks Regional Medical Center
🇺🇸Fort Smith, Arkansas, United States
Santa Monica - UCLA Medical Center
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, 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
Tallahassee Memorial Healthcare, Inc.
🇺🇸Tallahassee, Florida, United States
Ocala Neurodiagnostic Center
🇺🇸Ocala, Florida, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
St. Mary's Duluth Clinic
🇺🇸Duluth, Minnesota, United States
NJ Neuroscience Institute
🇺🇸Edison, New Jersey, United States
Neurology Group of Bergen County
🇺🇸Ridgewood, New Jersey, United States
Neurology Consultants Of Burlington County
🇺🇸Lumberton, New Jersey, United States
Kaleida Stroke Center
🇺🇸Buffalo, New York, United States
Shore Neurology
🇺🇸Toms River, New Jersey, United States
United Health Services Hospitals
🇺🇸Johnson City, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Winthrop University Hospital
🇺🇸Minneola, New York, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Medical University of Ohio
🇺🇸Toledo, Ohio, United States
The Toledo Hospital
🇺🇸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
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Neurological Consultants of Virginia Beach
🇺🇸Virginia Beach, Virginia, United States
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Gosford Hospital Department of Neurology
🇦🇺Gosford, New South Wales, Australia
Grey Nuns Community Hospital
🇨🇦Edmonton, Alberta, Canada
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Western Memorial Health Clinic
🇨🇦Corner Brook, Newfoundland and Labrador, Canada
Trillum Health Centre
🇨🇦Mississauga, Ontario, Canada
University of Alberta Hospital
🇨🇦Edmonton, Canada
Thunder Bay Regional Health Sciences Centre
🇨🇦Thunder Bay, Canada
Hospital Charles-Leymoyne
🇨🇦Greenfield Park, Quebec, Canada
City Hospital #31
🇷🇺Moscow, Russian Federation
University Clinical Hospital
🇵🇱Warsaw, Poland
Faculty Hospital 1, The Clinic of Neurology
🇨🇿Pilsen, Czech Republic
Military Medical Akademy Dept of Neurology
🇷🇺St. Petersburg, Russian Federation
Research Institute of Neurology RAMS
🇷🇺Moscow, Russian Federation
Vergelegen Medi-Clinic
🇿🇦Somerset West, South Africa
Sunninghill Hospital
🇿🇦Sunninghill, South Africa
Lo-Tung Pohai Hospital, Department of Neurology
🇨🇳IIan, Taiwan
Chung-Ho Memorial Hospital Kaohsiung Medical University
🇨🇳Kaohsiung, Taiwan
Kaohsiung Chang-Gung, Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital, Section of Neurology
🇨🇳Taichung, Taiwan
Chi-Mei Medical Center
🇨🇳Tainan, Taiwan
Kuang-Tien General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Cathay General Hospital Department of Neurology
🇨🇳Taipei City, Taiwan
Shin-Kong WHS Memorial Hospital
🇨🇳Taipei, Taiwan
Far Eastern Memorial Hospital
🇨🇳Taipei, Taiwan
Chang-Gung Memorial Hospital Linko Medical Center
🇨🇳Taoyuang, Taiwan
Institute of Neurological Sciences Southern General Hospital
🇬🇧Glasgow, United Kingdom
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
Royal Victoria Infirmary - Clinical Research Center
🇬🇧New Castle, United Kingdom
Florida Hospital Neuroloscience Institute
🇺🇸Orlando, Florida, United States
The Queens Medical Center, Neuroscience Institute
🇺🇸Honolulu, Hawaii, United States
Clinical Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Seton Medical Center
🇺🇸Austin, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Brackenridge Hospital
🇺🇸Austin, Texas, United States
St. Lukes Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Tri-Service General Hospital
🇨🇳Taipei, Taiwan