Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00141011
• Other study ID #: NTI-ASP-0502
• Status: Terminated
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: December 21, 2009
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: December 2009
• Source: Neurobiological Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 277
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Infarction
• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Infarction
• Ischemia
• Stroke

Intervention

Drug:
• Ancrod (Viprinex)
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
• Placebo
0.6 mL/kg/hr

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Gosford Hospital Department of Neurology	Gosford	New South Wales
Australia	National Stroke Research Institute	Heidelberg Heights	Victoria
Canada	Western Memorial Health Clinic	Corner Brook	Newfoundland and Labrador
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton
Canada	Hospital Charles-Leymoyne	Greenfield Park	Quebec
Canada	London Health Sciences Centre - University Hospital	London	Ontario
Canada	Trillum Health Centre	Mississauga	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay
Czech Republic	St. Anne's Faculty Hospital	Brno
Czech Republic	Faculty Hospital 1, The Clinic of Neurology	Pilsen
Netherlands	St. Anna Hospital	Geldrop
Poland	University Clinical Hospital	Warsaw
Russian Federation	City Hospital #31	Moscow
Russian Federation	Research Institute of Neurology RAMS	Moscow
Russian Federation	Military Medical Akademy Dept of Neurology	St. Petersburg
South Africa	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
Taiwan	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
Taiwan	Kaohsiung Chang-Gung, Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical Hospital	Taichung
Taiwan	Kuang-Tien General Hospital	Taichung
Taiwan	Taichung Veterans General Hospital, Section of Neurology	Taichung
Taiwan	Chi-Mei Medical Center	Tainan
Taiwan	En Chu Kong Hospital	Taipei
Taiwan	Far Eastern Memorial Hospital	Taipei
Taiwan	Shin-Kong WHS Memorial Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Cathay General Hospital Department of Neurology	Taipei City
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang-Gung Memorial Hospital Linko Medical Center	Taoyuang
Taiwan	Chang-Gung Memorial Hospital, Linko Medical Center	Taoyuang
United Kingdom	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	New Castle
United States	Brackenridge Hospital	Austin	Texas
United States	Seton Medical Center	Austin	Texas
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Beaufort Memorial Hospital	Beaufort	South Carolina
United States	Deaconess Billings Clinical Research Center	Billings	Montana
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Kaleida Stroke Center	Buffalo	New York
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Mercy Hospital	Chicago	Illinois
United States	Wayne State University	Detroit	Michigan
United States	St. Mary's Duluth Clinic	Duluth	Minnesota
United States	NJ Neuroscience Institute	Edison	New Jersey
United States	Elkhart Clinic, LLC - Neurology	Elkhart	Indiana
United States	Northshore Clinical Associates	Erie	Pennsylvania
United States	Neurologic Consultants, P.A.	Fort Lauderdale	Florida
United States	Sparks Regional Medical Center	Fort Smith	Arkansas
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Minneapolis Clinic of Neurology	Golden Valley	Minnesota
United States	Lebauer Cardiovascular Research Foundation at Moses Cone Hospital	Greensboro	North Carolina
United States	Westmoreland Neurology Associates, Inc.	Greensburg	Pennsylvania
United States	The Queens Medical Center, Neuroscience Institute	Honolulu	Hawaii
United States	Methodist Hospital / Neurological Institute	Houston	Texas
United States	Shands Jacksonville / University of Florida	Jacksonville	Florida
United States	United Health Services Hospitals	Johnson City	New York
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	Neurology Consultants Of Burlington County	Lumberton	New Jersey
United States	Methodist University Hospital	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	St. Lukes Medical Center	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Minneola	New York
United States	UMDNJ / Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Weill Medical College of Cornell University	New York	New York
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Ocala Neurodiagnostic Center	Ocala	Florida
United States	The Neurology Center: Tri-City Medical Center	Oceanside	California
United States	Florida Hospital Neuroloscience Institute	Orlando	Florida
United States	Mayo Clinic Hospital / Arizona	Phoenix	Arizona
United States	Fawcett Memorial Hospital	Port Charlotte	Florida
United States	Peace River Regional Medical Center	Port Charlotte	Florida
United States	Miriam Hospital	Providence	Rhode Island
United States	Shasta Regional Medical	Redding	California
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Neurology Group of Bergen County	Ridgewood	New Jersey
United States	Rochester General Hospital	Rochester	New York
United States	Strong Memorial Hospital	Rochester	New York
United States	University of Texas Health Sciences Center	San Antonio	Texas
United States	Harborview Medical Center	Seattle	Washington
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Tallahassee Memorial Healthcare, Inc.	Tallahassee	Florida
United States	Medical University of Ohio	Toledo	Ohio
United States	The Toledo Hospital	Toledo	Ohio
United States	Shore Neurology	Toms River	New Jersey
United States	Neurological Consultants of Virginia Beach	Virginia Beach	Virginia
United States	Clinical Research of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Neurobiological Technologies

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  Netherlands,  Poland,  Russian Federation,  South Africa,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder analysis based on Modified Rankin Scale (mRS)		90 days
Secondary	National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx		90 days

External Links

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