ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

January 11, 2010 updated by: Neurobiological Technologies

ASP II (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)

311

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, Australia
        • Concord Hospital Neuroscience Department
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital
    • Queensland
      • Southport, Queensland, Australia
        • Gold Coast Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Moash Medical Center Dept of Neurology
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Prahan, Melbourne, Victoria, Australia, 3184
        • Alfred Hospital Research - Melbourne
  • Austria
      • Graz, Austria, 8036
        • Medical University of Affairs
      • Linz, Austria, A4020
        • Neurologische Intensivstation
  • Czech Republic
      • Hradec-Kralove, Czech Republic, 500 05
        • University Hospital Hradec Kralove Neurological Department
      • Olomouc, Czech Republic, 77520
        • PalackyUniversity Faculty of Medicine and Dentistry and University Hospital
      • Ostrava, Czech Republic, 703 84
        • Vitkovice Hospital Department of Neurology
      • Pardubice, Czech Republic, 53 203
        • Regional Hospital Pardubice
      • Prague, Czech Republic, 12000
        • General University Hospital Clinic of Neurology-Stroke Center
      • Prague, Czech Republic, 14059
        • Thomayer's Faculty Clinic of Neurology
      • Prague, Czech Republic, 15006
        • University Hospital Motol Department of Neurology
  • Israel
      • Ashkelon, Israel, 78306
        • Barzilai Medical Center
      • Beer Sheva, Israel, 84105
        • Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev
      • Haifa, Israel, 31048
        • Bnei-Zion Medical Center
      • Haifa, Israel, 31096
        • Rambam Medical Center Dept. of Neurology
      • Holon, Israel, 58100
        • Wolfson Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Ein-Karem Medical Center
      • Nahariya, Israel, 22100
        • Western Galilee Hospital Neurology Dept
      • Petach Tikva, Israel, 49372
        • Rabin Medical Center Golda Campus (Hasharon)
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Medical Center
      • Tel Hashomer, Israel, 52621
        • Chaim Sheba Medical Center Neurology Dept
  • New Zealand
      • Auckland, New Zealand, 1001
        • Auckland City Hospital
      • Christchurch, New Zealand, 4710
        • Cristchurch Hospitial
  • Poland
      • Gdansk, Poland, 80294
        • Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum
      • Katowice, Poland, 40752
        • Katedra i Klinika Neurologii, Wieku Podesziego
      • Lublin, Poland, 20090
        • Klinika Neurologii Akademii Medycznej w Lublinie
      • Poznan, Poland, 61-485
        • Centrum Medycne HCP sp.zo.o Dept. Neurlogy
      • Warsaw, Poland, 02-957
        • Institute for Psychiatry and Neurology 2nd Neurology Dept.
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
        • City Clinical Hospital MU KGB Nr. 40
      • Jaroslavl, Russian Federation
        • Jaroslav Regional Clinical Hospital State Institution of Healthcare
      • Kazan, Russian Federation, 420101
        • State Multiregional Clinical Diagnostical GU MKDZ
      • Moscow, Russian Federation, 121359
        • Central Clinical Hospital of the President of the Russian Federation
      • Moscow, Russian Federation
        • Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia
      • Novosibirsk, Russian Federation, 630047
        • Municipal Institution of Health City Clinical Hospital No. 1
      • Petrozawodsk, Russian Federation
        • Hospital Baranov
      • Rostov-on Don, Russian Federation, 344011
        • Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"
      • Samara, Russian Federation, 443096
        • City Hospital Nr. 1 of Pirogov
      • St Petersburg, Russian Federation
        • State Medical University named after IP Pavlov Leo Tolstoj
      • St. Petersburg, Russian Federation, 194354
        • Multiprofile City Clinic No. 2
      • St. Petersburg, Russian Federation
        • City Clinic Neurology N2 of Marinski Hospital
  • Slovakia
      • Bratislava, Slovakia, 81369
        • Fakultna nemocnica s poliklinikou Bratislava
      • Levoca, Slovakia, 05401
        • Vseobecna nemocnica s polokliniknikou Levoca a.s.
      • Martin, Slovakia, 03659
        • Martinska Fakultna Nemocnica
      • Nitra, Slovakia, 949 01
        • Fakultna nemocnica Nitra
      • Nitra, Slovakia, 95001
        • Fakultna nemocnica Nitra
      • Nova Ves, Slovakia, 05201
        • Nemocnica s poliklinikou Spisska
      • Prestov, Slovakia, 08181
        • Fakultna nemocnica s poliklinikou J.A. Reimana
      • Trnava, Slovakia, 91775
        • Fakultna Nemocnica Trnava
  • South Africa
      • Worcester, South Africa, 6850
        • Clinical Projects Research
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier universitaire Vaudois, Dept. of Neurology
      • Zurich, Switzerland, CH8091
        • Universitätsspital Zürich
  • United States
    • California
      • Chico, California, United States, 95973
        • Enloe Medical Center
      • Fresno, California, United States, 93701
        • UCSF-Fresno
      • La Mesa, California, United States, 91942
        • Sherry Braheny MD - A Prof. Corporation
      • Sacramento, California, United States, 95825
        • Mercy General Hospital
      • Thousand Oaks, California, United States, 91360
        • Los Robles Hospital and Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Florida
      • Bradenton, Florida, United States, 34208
        • Manatee Memorial Hospital
      • Bradenton, Florida, United States, 34250
        • Bradenton Research Center
      • Melbourne, Florida, United States, 32901
        • Melbourne Internal Medicine Associates
      • Naples, Florida, United States, 34102
        • Naples Community Hospital
      • Naples, Florida, United States, 34102
        • Collier Neurologic Specialists
      • St. Petersburg, Florida, United States, 33701
        • Suncoast Neuroscience Associates
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Joan Glancy Memorial Hospital
      • Duluth, Georgia, United States, 30096
        • Joan Glancy Memorial Hospital
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Medical Center
      • Lithonia, Georgia, United States, 30058
        • Dekalb Medical Center-Hillandale
      • Savannah, Georgia, United States, 31419
        • St. Joseph's Hospital
      • Savannah, Georgia, United States, 31405
        • Candler Hospital
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • OSF Saint Joseph Medical Center
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital Mid America Brain and Stroke Institute
      • St. Louis, Missouri, United States, 63110
        • St. Louis University Hospital - Dept of Neurology
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Neuroscience Institute at Sunrise
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
      • Trenton, New Jersey, United States, 08629
        • Neuroscience Institute St Francis Medical Center
    • New York
      • Brooklyn, New York, United States, 11220
        • Lutheran Medical Center
      • Lawrence, New York, United States, 11559
        • Five Towns Neuroscience Research
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Kettering, Ohio, United States, 45429
        • Charles F. Kettering Memorial Hospital
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Hospital
      • Lancaster, Pennsylvania, United States, 17603
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19102-1101
        • Hahenmann University Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health
    • Tennessee
      • Chattanooga, Tennessee, United States, 97401
        • Chattanooga Center for Neurologic Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Overlake Hospital Medical Center
      • Olympia, Washington, United States, 98506
        • Providence St. Peter Hospital
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Memorial Hospital

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.
Biological: Ancrod (Viprinex)
0.167 IU/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
Modified Rankin Score - responder analysis
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Barthel Index, NIHSS
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

March 1, 2006

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

March 6, 2006

First Submitted That Met QC Criteria

March 6, 2006

First Posted (ESTIMATE)

March 8, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTI-ASP-0503

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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