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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
277

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Responder analysis based on Modified Rankin Scale (mRS)
Time Frame: 90 days
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neurobiological Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2005

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2005

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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