Clinical trial NCT00141011: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stroke
Cerebral Ischemia
Brain Infarction
Keywords: Stroke
Fibrinogen
Reperfusion
Thrombolysis
Lead sponsor: Neurobiological Technologies
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Responder analysis based on Modified Rankin Scale (mRS)
timeFrame: 90 days
Secondary outcomes:
measure: National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx
timeFrame: 90 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital / Arizona
state: Arizona
city: Fort Smith
country: United States
facility: Sparks Regional Medical Center
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University School of Medicine
state: California
city: Los Angeles
country: United States
facility: Santa Monica - UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Oceanside
country: United States
facility: The Neurology Center: Tri-City Medical Center
state: California
city: Redding
country: United States
facility: Shasta Regional Medical
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Neurologic Consultants, P.A.
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville / University of Florida
state: Florida
city: Ocala
country: United States
facility: Ocala Neurodiagnostic Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Neuroloscience Institute
state: Florida
city: Port Charlotte
country: United States
facility: Fawcett Memorial Hospital
state: Florida
city: Port Charlotte
country: United States
facility: Peace River Regional Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Healthcare, Inc.
state: Florida
city: Honolulu
country: United States
facility: The Queens Medical Center, Neuroscience Institute
state: Hawaii
city: Chicago
country: United States
facility: Mercy Hospital
state: Illinois
city: Elkhart
country: United States
facility: Elkhart Clinic, LLC - Neurology
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic
state: Minnesota
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology
state: Minnesota
city: Billings
country: United States
facility: Deaconess Billings Clinical Research Center
state: Montana
city: Edison
country: United States
facility: NJ Neuroscience Institute
state: New Jersey
city: Lumberton
country: United States
facility: Neurology Consultants Of Burlington County
state: New Jersey
city: New Brunswick
country: United States
facility: UMDNJ / Robert Wood Johnson Medical School
state: New Jersey
city: Ridgewood
country: United States
facility: Neurology Group of Bergen County
state: New Jersey
city: Toms River
country: United States
facility: Shore Neurology
state: New Jersey
city: Buffalo
country: United States
facility: Kaleida Stroke Center
state: New York
city: Johnson City
country: United States
facility: United Health Services Hospitals
state: New York
city: Minneola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Greensboro
country: United States
facility: Lebauer Cardiovascular Research Foundation at Moses Cone Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Research of Winston-Salem
state: North Carolina
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Toledo
country: United States
facility: Medical University of Ohio
state: Ohio
city: Erie
country: United States
facility: Northshore Clinical Associates
state: Pennsylvania
city: Greensburg
country: United States
facility: Westmoreland Neurology Associates, Inc.
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Beaufort
country: United States
facility: Beaufort Memorial Hospital
state: South Carolina
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Austin
country: United States
facility: Brackenridge Hospital
state: Texas
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Houston
country: United States
facility: Methodist Hospital / Neurological Institute
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Virginia Beach
country: United States
facility: Neurological Consultants of Virginia Beach
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Milwaukee
country: United States
facility: St. Lukes Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Gosford
country: Australia
facility: Gosford Hospital Department of Neurology
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Heidelberg Heights
country: Australia
facility: National Stroke Research Institute
state: Victoria
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Corner Brook
country: Canada
facility: Western Memorial Health Clinic
state: Newfoundland and Labrador
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Trillum Health Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: Hospital Charles-Leymoyne
state: Quebec
city: Edmonton
country: Canada
facility: University of Alberta Hospital
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
city: Brno
country: Czech Republic
facility: St. Anne's Faculty Hospital
city: Pilsen
country: Czech Republic
facility: Faculty Hospital 1, The Clinic of Neurology
city: Geldrop
country: Netherlands
facility: St. Anna Hospital
city: Warsaw
country: Poland
facility: University Clinical Hospital
city: Moscow
country: Russian Federation
facility: City Hospital #31
city: Moscow
country: Russian Federation
facility: Research Institute of Neurology RAMS
city: St. Petersburg
country: Russian Federation
facility: Military Medical Akademy Dept of Neurology
city: Berea, Durban
country: South Africa
facility: St. Augustine's Hospital
state: Kwazulu Natal
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
city: Somerset West
country: South Africa
facility: Vergelegen Medi-Clinic
city: Sunninghill
country: South Africa
facility: Sunninghill Hospital
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital, Chief Department of Neurology
city: IIan
country: Taiwan
facility: Lo-Tung Pohai Hospital, Department of Neurology
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital Kaohsiung Medical University
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang-Gung, Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital, Section of Neurology
city: Taichung
country: Taiwan
facility: Kuang-Tien General Hospital
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Center
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Cathay General Hospital Department of Neurology
city: Taipei
country: Taiwan
facility: Shin-Kong WHS Memorial Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: En Chu Kong Hospital
city: Taoyuang
country: Taiwan
facility: Chang-Gung Memorial Hospital Linko Medical Center
city: Taoyuang
country: Taiwan
facility: Chang-Gung Memorial Hospital, Linko Medical Center
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen, Polwarth Building, Institute of Medical Sciences, Dept. of Medicine & Theropeutics
city: Glasgow
country: United Kingdom
facility: Institute of Neurological Sciences Southern General Hospital
city: New Castle
country: United Kingdom
facility: Royal Victoria Infirmary - Clinical Research Center
Study officials:
affiliation: Neurobiological Technologies
name: Warren Wasiewski, M.D.
role: STUDY_DIRECTOR
References: