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

Primary Purpose

Stroke, Cerebral Ischemia, Brain Infarction

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ancrod (Viprinex)
Placebo
Sponsored by
Neurobiological Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Fibrinogen, Reperfusion, Thrombolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Hospital / Arizona
  • Sparks Regional Medical Center
  • Loma Linda University School of Medicine
  • Santa Monica - UCLA Medical Center
  • UCLA Medical Center
  • Hoag Memorial Hospital
  • The Neurology Center: Tri-City Medical Center
  • Shasta Regional Medical
  • Bridgeport Hospital
  • Neurologic Consultants, P.A.
  • Shands Jacksonville / University of Florida
  • Ocala Neurodiagnostic Center
  • Florida Hospital Neuroloscience Institute
  • Fawcett Memorial Hospital
  • Peace River Regional Medical Center
  • Tallahassee Memorial Healthcare, Inc.
  • The Queens Medical Center, Neuroscience Institute
  • Mercy Hospital
  • Elkhart Clinic, LLC - Neurology
  • Fort Wayne Neurological Center
  • Parkview Research Center
  • Sinai Hospital of Baltimore
  • Baystate Medical Center
  • Wayne State University
  • St. Mary's Duluth Clinic
  • Minneapolis Clinic of Neurology
  • Deaconess Billings Clinical Research Center
  • NJ Neuroscience Institute
  • Neurology Consultants Of Burlington County
  • UMDNJ / Robert Wood Johnson Medical School
  • Neurology Group of Bergen County
  • Shore Neurology
  • Kaleida Stroke Center
  • United Health Services Hospitals
  • Winthrop University Hospital
  • Weill Medical College of Cornell University
  • Rochester General Hospital
  • Strong Memorial Hospital
  • Presbyterian Hospital
  • Lebauer Cardiovascular Research Foundation at Moses Cone Hospital
  • Clinical Research of Winston-Salem
  • The Toledo Hospital
  • Medical University of Ohio
  • Northshore Clinical Associates
  • Westmoreland Neurology Associates, Inc.
  • Miriam Hospital
  • Beaufort Memorial Hospital
  • Methodist University Hospital
  • Brackenridge Hospital
  • Seton Medical Center
  • Methodist Hospital / Neurological Institute
  • University of Texas Health Sciences Center
  • Virginia Commonwealth University
  • Neurological Consultants of Virginia Beach
  • Harborview Medical Center
  • Madigan Army Medical Center
  • St. Lukes Medical Center
  • Medical College of Wisconsin
  • Gosford Hospital Department of Neurology
  • Flinders Medical Centre
  • Box Hill Hospital
  • National Stroke Research Institute
  • Grey Nuns Community Hospital
  • Western Memorial Health Clinic
  • London Health Sciences Centre - University Hospital
  • Trillum Health Centre
  • Hospital Charles-Leymoyne
  • University of Alberta Hospital
  • Thunder Bay Regional Health Sciences Centre
  • St. Anne's Faculty Hospital
  • Faculty Hospital 1, The Clinic of Neurology
  • St. Anna Hospital
  • University Clinical Hospital
  • City Hospital #31
  • Research Institute of Neurology RAMS
  • Military Medical Akademy Dept of Neurology
  • St. Augustine's Hospital
  • Tiervlei Trial Centre
  • Vergelegen Medi-Clinic
  • Sunninghill Hospital
  • Changhua Christian Hospital, Chief Department of Neurology
  • Lo-Tung Pohai Hospital, Department of Neurology
  • Chung-Ho Memorial Hospital Kaohsiung Medical University
  • Kaohsiung Chang-Gung, Memorial Hospital
  • Chung Shan Medical Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital, Section of Neurology
  • Kuang-Tien General Hospital
  • Chi-Mei Medical Center
  • National Taiwan University Hospital
  • Cathay General Hospital Department of Neurology
  • Shin-Kong WHS Memorial Hospital
  • Tri-Service General Hospital
  • Far Eastern Memorial Hospital
  • En Chu Kong Hospital
  • Chang-Gung Memorial Hospital Linko Medical Center
  • Chang-Gung Memorial Hospital, Linko Medical Center
  • University of Aberdeen, Polwarth Building, Institute of Medical Sciences, Dept. of Medicine & Theropeutics
  • Institute of Neurological Sciences Southern General Hospital
  • Royal Victoria Infirmary - Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous ancrod

Intravenous Placebo

Arm Description

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 at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.

Outcomes

Primary Outcome Measures

Responder analysis based on Modified Rankin Scale (mRS)

Secondary Outcome Measures

National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx

Full Information

First Posted
August 30, 2005
Last Updated
December 21, 2009
Sponsor
Neurobiological Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT00141011
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neurobiological Technologies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Ischemia, Brain Infarction
Keywords
Stroke, Fibrinogen, Reperfusion, Thrombolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous ancrod
Arm Type
Experimental
Arm Description
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.
Arm Title
Intravenous Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
Intervention Type
Drug
Intervention Name(s)
Ancrod (Viprinex)
Intervention Description
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.6 mL/kg/hr
Primary Outcome Measure Information:
Title
Responder analysis based on Modified Rankin Scale (mRS)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Wasiewski, M.D.
Organizational Affiliation
Neurobiological Technologies
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Hospital / Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Sparks Regional Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Loma Linda University School of Medicine
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Santa Monica - UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
The Neurology Center: Tri-City Medical Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Shasta Regional Medical
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Neurologic Consultants, P.A.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Shands Jacksonville / University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Ocala Neurodiagnostic Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Florida Hospital Neuroloscience Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Fawcett Memorial Hospital
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Peace River Regional Medical Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Tallahassee Memorial Healthcare, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32303
Country
United States
Facility Name
The Queens Medical Center, Neuroscience Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Mercy Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Elkhart Clinic, LLC - Neurology
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. Mary's Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Deaconess Billings Clinical Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
NJ Neuroscience Institute
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Facility Name
Neurology Consultants Of Burlington County
City
Lumberton
State/Province
New Jersey
ZIP/Postal Code
08048
Country
United States
Facility Name
UMDNJ / Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Neurology Group of Bergen County
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Shore Neurology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Kaleida Stroke Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
United Health Services Hospitals
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Winthrop University Hospital
City
Minneola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Lebauer Cardiovascular Research Foundation at Moses Cone Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Clinical Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Medical University of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Northshore Clinical Associates
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Facility Name
Westmoreland Neurology Associates, Inc.
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Beaufort Memorial Hospital
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
34205
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Brackenridge Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Seton Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Methodist Hospital / Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Neurological Consultants of Virginia Beach
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
St. Lukes Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Gosford Hospital Department of Neurology
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
National Stroke Research Institute
City
Heidelberg Heights
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
1100
Country
Canada
Facility Name
Western Memorial Health Clinic
City
Corner Brook
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A2H 4B8
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
Country
Canada
Facility Name
Trillum Health Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B1B8
Country
Canada
Facility Name
Hospital Charles-Leymoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2h1
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
ZIP/Postal Code
P7B7C7
Country
Canada
Facility Name
St. Anne's Faculty Hospital
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
Faculty Hospital 1, The Clinic of Neurology
City
Pilsen
ZIP/Postal Code
30460
Country
Czech Republic
Facility Name
St. Anna Hospital
City
Geldrop
ZIP/Postal Code
5660 AB
Country
Netherlands
Facility Name
University Clinical Hospital
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
City Hospital #31
City
Moscow
ZIP/Postal Code
119415
Country
Russian Federation
Facility Name
Research Institute of Neurology RAMS
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Military Medical Akademy Dept of Neurology
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
St. Augustine's Hospital
City
Berea, Durban
State/Province
Kwazulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Tiervlei Trial Centre
City
Cape Town
ZIP/Postal Code
7536
Country
South Africa
Facility Name
Vergelegen Medi-Clinic
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Sunninghill Hospital
City
Sunninghill
ZIP/Postal Code
2157
Country
South Africa
Facility Name
Changhua Christian Hospital, Chief Department of Neurology
City
Changhua
ZIP/Postal Code
50022
Country
Taiwan
Facility Name
Lo-Tung Pohai Hospital, Department of Neurology
City
IIan
ZIP/Postal Code
265
Country
Taiwan
Facility Name
Chung-Ho Memorial Hospital Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Chang-Gung, Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83305
Country
Taiwan
Facility Name
Chung Shan Medical Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Taichung Veterans General Hospital, Section of Neurology
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Kuang-Tien General Hospital
City
Taichung
ZIP/Postal Code
433
Country
Taiwan
Facility Name
Chi-Mei Medical Center
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Cathay General Hospital Department of Neurology
City
Taipei City
ZIP/Postal Code
11073
Country
Taiwan
Facility Name
Shin-Kong WHS Memorial Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
220
Country
Taiwan
Facility Name
En Chu Kong Hospital
City
Taipei
ZIP/Postal Code
23702
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital Linko Medical Center
City
Taoyuang
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, Linko Medical Center
City
Taoyuang
ZIP/Postal Code
333
Country
Taiwan
Facility Name
University of Aberdeen, Polwarth Building, Institute of Medical Sciences, Dept. of Medicine & Theropeutics
City
Aberdeen
ZIP/Postal Code
AB252ZD
Country
United Kingdom
Facility Name
Institute of Neurological Sciences Southern General Hospital
City
Glasgow
ZIP/Postal Code
G514TF
Country
United Kingdom
Facility Name
Royal Victoria Infirmary - Clinical Research Center
City
New Castle
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.ntii.com
Description
Related Info

Learn more about this trial

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

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