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

December 21, 2009 updated by: Neurobiological Technologies

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Gosford Hospital Department of Neurology
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Box Hill, Victoria, Australia
        • Box Hill Hospital
      • Heidelberg Heights, Victoria, Australia, 3081
        • National Stroke Research Institute
  • Canada
      • Edmonton, Canada, T6G2B7
        • University of Alberta Hospital
      • Thunder Bay, Canada, P7B7C7
        • Thunder Bay Regional Health Sciences Centre
    • Alberta
      • Edmonton, Alberta, Canada, 1100
        • Grey Nuns Community Hospital
    • Newfoundland and Labrador
      • Corner Brook, Newfoundland and Labrador, Canada, A2H 4B8
        • Western Memorial Health Clinic
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre - University Hospital
      • Mississauga, Ontario, Canada, L5B1B8
        • Trillum Health Centre
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V2h1
        • Hospital Charles-Leymoyne
  • Czech Republic
      • Brno, Czech Republic, 65691
        • St. Anne's Faculty Hospital
      • Pilsen, Czech Republic, 30460
        • Faculty Hospital 1, The Clinic of Neurology
  • Netherlands
      • Geldrop, Netherlands, 5660 AB
        • St. Anna Hospital
  • Poland
      • Warsaw, Poland, 02-097
        • University Clinical Hospital
  • Russian Federation
      • Moscow, Russian Federation, 119415
        • City Hospital #31
      • Moscow, Russian Federation, 125367
        • Research Institute of Neurology RAMS
      • St. Petersburg, Russian Federation, 194044
        • Military Medical Akademy Dept of Neurology
  • South Africa
      • Cape Town, South Africa, 7536
        • Tiervlei Trial Centre
      • Somerset West, South Africa, 7130
        • Vergelegen Medi-Clinic
      • Sunninghill, South Africa, 2157
        • Sunninghill Hospital
    • Kwazulu Natal
      • Berea, Durban, Kwazulu Natal, South Africa, 4001
        • St. Augustine's Hospital
  • Taiwan
      • Changhua, Taiwan, 50022
        • Changhua Christian Hospital, Chief Department of Neurology
      • IIan, Taiwan, 265
        • Lo-Tung Pohai Hospital, Department of Neurology
      • Kaohsiung, Taiwan, 807
        • Chung-Ho Memorial Hospital Kaohsiung Medical University
      • Kaohsiung, Taiwan, 83305
        • Kaohsiung Chang-Gung, Memorial Hospital
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taichung, Taiwan, 402
        • Chung Shan Medical Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital, Section of Neurology
      • Taichung, Taiwan, 433
        • Kuang-Tien General Hospital
      • Tainan, Taiwan, 710
        • Chi-Mei Medical Center
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Taipei, Taiwan, 111
        • Shin-Kong WHS Memorial Hospital
      • Taipei, Taiwan, 23702
        • En Chu Kong Hospital
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei City, Taiwan, 11073
        • Cathay General Hospital Department of Neurology
      • Taoyuang, Taiwan, 333
        • Chang-Gung Memorial Hospital Linko Medical Center
      • Taoyuang, Taiwan, 333
        • Chang-Gung Memorial Hospital, Linko Medical Center
  • United Kingdom
      • Aberdeen, United Kingdom, AB252ZD
        • University of Aberdeen, Polwarth Building, Institute of Medical Sciences, Dept. of Medicine & Theropeutics
      • Glasgow, United Kingdom, G514TF
        • Institute of Neurological Sciences Southern General Hospital
      • New Castle, United Kingdom
        • Royal Victoria Infirmary - Clinical Research Center
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital / Arizona
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Sparks Regional Medical Center
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University School of Medicine
      • Los Angeles, California, United States, 90024
        • UCLA Medical Center
      • Los Angeles, California, United States, 90024
        • Santa Monica - UCLA Medical Center
      • Newport Beach, California, United States, 92658
        • Hoag Memorial Hospital
      • Oceanside, California, United States, 92056
        • The Neurology Center: Tri-City Medical Center
      • Redding, California, United States, 96001
        • Shasta Regional Medical
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Neurologic Consultants, P.A.
      • Jacksonville, Florida, United States, 32209
        • Shands Jacksonville / University of Florida
      • Ocala, Florida, United States, 34471
        • Ocala Neurodiagnostic Center
      • Orlando, Florida, United States, 32804
        • Florida Hospital Neuroloscience Institute
      • Port Charlotte, Florida, United States, 33952
        • Fawcett Memorial Hospital
      • Port Charlotte, Florida, United States, 33952
        • Peace River Regional Medical Center
      • Tallahassee, Florida, United States, 32303
        • Tallahassee Memorial Healthcare, Inc.
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queens Medical Center, Neuroscience Institute
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Mercy Hospital
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Elkhart Clinic, LLC - Neurology
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Neurological Center
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Mary's Duluth Clinic
      • Golden Valley, Minnesota, United States, 55422
        • Minneapolis Clinic of Neurology
    • Montana
      • Billings, Montana, United States, 59101
        • Deaconess Billings Clinical Research Center
    • New Jersey
      • Edison, New Jersey, United States, 08818
        • NJ Neuroscience Institute
      • Lumberton, New Jersey, United States, 08048
        • Neurology Consultants Of Burlington County
      • New Brunswick, New Jersey, United States, 08901
        • UMDNJ / Robert Wood Johnson Medical School
      • Ridgewood, New Jersey, United States, 07450
        • Neurology Group of Bergen County
      • Toms River, New Jersey, United States, 08755
        • Shore Neurology
    • New York
      • Buffalo, New York, United States, 14209
        • Kaleida Stroke Center
      • Johnson City, New York, United States, 13790
        • United Health Services Hospitals
      • Minneola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital
      • Greensboro, North Carolina, United States, 27401
        • Lebauer Cardiovascular Research Foundation at Moses Cone Hospital
      • Winston-Salem, North Carolina, United States, 27103
        • Clinical Research of Winston-Salem
    • Ohio
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Northshore Clinical Associates
      • Greensburg, Pennsylvania, United States, 15601
        • Westmoreland Neurology Associates, Inc.
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
    • South Carolina
      • Beaufort, South Carolina, United States, 34205
        • Beaufort Memorial Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Medical Center
      • Austin, Texas, United States, 78701
        • Brackenridge Hospital
      • Houston, Texas, United States, 77030
        • Methodist Hospital / Neurological Institute
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Sciences Center
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University
      • Virginia Beach, Virginia, United States, 23454
        • Neurological Consultants of Virginia Beach
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Lukes Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Ancrod (Viprinex)
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
PLACEBO_COMPARATOR: Intravenous Placebo
Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
Drug: Placebo
0.6 mL/kg/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Responder analysis based on Modified Rankin Scale (mRS)
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurobiological Technologies

Investigators

  • Study Director: Warren Wasiewski, M.D., Neurobiological Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (ESTIMATE)

September 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 21, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTI-ASP-0502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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