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

This study has been terminated.
(Futility)
Sponsor:
Information provided by:
Neurobiological Technologies
ClinicalTrials.gov Identifier:
NCT00300196
First received: March 6, 2006
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Stroke
Cerebral Ischemia
Brain Infarction
Biological: Ancrod (Viprinex)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Neurobiological Technologies:

Primary Outcome Measures:
  • Modified Rankin Score - responder analysis [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Barthel Index, NIHSS [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 311
Study Start Date: March 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300196

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

Additional Information:
No publications provided

Responsible Party: Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc. (no longer active)
ClinicalTrials.gov Identifier: NCT00300196     History of Changes
Other Study ID Numbers: NTI-ASP-0503
Study First Received: March 6, 2006
Last Updated: January 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurobiological Technologies:
Stroke
Fibrinogen
Reperfusion
Thrombolysis

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Infarction
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Ischemia
Pathologic Processes
Necrosis
Ancrod
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014