ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
NCT ID: NCT00300196
Last Updated: 2010-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
311 participants
INTERVENTIONAL
2006-03-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Ancrod (Viprinex)
0.167 IU/kg/hr IV for 2-3 hours
Intravenous Placebo
Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
Placebo
0.6 mL/kg/hr
Interventions
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Ancrod (Viprinex)
0.167 IU/kg/hr IV for 2-3 hours
Placebo
0.6 mL/kg/hr
Eligibility Criteria
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Inclusion Criteria
* Baseline NIHSS \> 5
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Neurobiological Technologies
INDUSTRY
Responsible Party
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Neurobiological Technologies, Inc. (no longer active)
Principal Investigators
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Warren Wasiewski, M.D.
Role: STUDY_DIRECTOR
Neurobiological Technologies
Locations
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Enloe Medical Center
Chico, California, United States
UCSF-Fresno
Fresno, California, United States
Sherry Braheny MD - A Prof. Corporation
La Mesa, California, United States
Mercy General Hospital
Sacramento, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, United States
Collier Neurologic Specialists
Naples, Florida, United States
Naples Community Hospital
Naples, Florida, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, United States
Joan Glancy Memorial Hospital
Decatur, Georgia, United States
Joan Glancy Memorial Hospital
Duluth, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Dekalb Medical Center-Hillandale
Lithonia, Georgia, United States
Candler Hospital
Savannah, Georgia, United States
St. Joseph's Hospital
Savannah, Georgia, United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Saint Luke's Hospital Mid America Brain and Stroke Institute
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
St. Louis University Hospital - Dept of Neurology
St Louis, Missouri, United States
Nevada Neuroscience Institute at Sunrise
Las Vegas, Nevada, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Neuroscience Institute St Francis Medical Center
Trenton, New Jersey, United States
Lutheran Medical Center
Brooklyn, New York, United States
Five Towns Neuroscience Research
Lawrence, New York, United States
Aultman Hospital
Canton, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Hahenmann University Hospital
Philadelphia, Pennsylvania, United States
AnMed Health
Anderson, South Carolina, United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
Providence St. Peter Hospital
Olympia, Washington, United States
CAMC Memorial Hospital
Charleston, West Virginia, United States
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
Gold Coast Hospital
Southport, Queensland, Australia
Moash Medical Center Dept of Neurology
Clayton, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Alfred Hospital Research - Melbourne
Prahan, Melbourne, Victoria, Australia
Concord Hospital Neuroscience Department
New South Wales, , Australia
Medical University of Affairs
Graz, , Austria
Neurologische Intensivstation
Linz, , Austria
University Hospital Hradec Kralove Neurological Department
Hradec Králové, , Czechia
PalackyUniversity Faculty of Medicine and Dentistry and University Hospital
Olomouc, , Czechia
Vitkovice Hospital Department of Neurology
Ostrava, , Czechia
Regional Hospital Pardubice
Pardubice, , Czechia
General University Hospital Clinic of Neurology-Stroke Center
Prague, , Czechia
Thomayer's Faculty Clinic of Neurology
Prague, , Czechia
University Hospital Motol Department of Neurology
Prague, , Czechia
Barzilai Medical Center
Ashkelon, , Israel
Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev
Beersheba, , Israel
Bnei-Zion Medical Center
Haifa, , Israel
Rambam Medical Center Dept. of Neurology
Haifa, , Israel
Wolfson Medical Center
Holon, , Israel
Hadassah Ein-Karem Medical Center
Jerusalem, , Israel
Western Galilee Hospital Neurology Dept
Nahariya, , Israel
Rabin Medical Center Golda Campus (Hasharon)
Petah Tikva, , Israel
Tel-Aviv Medical Center
Tel Aviv, , Israel
Chaim Sheba Medical Center Neurology Dept
Tel Litwinsky, , Israel
Auckland City Hospital
Auckland, , New Zealand
Cristchurch Hospitial
Christchurch, , New Zealand
Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum
Gdansk, , Poland
Katedra i Klinika Neurologii, Wieku Podesziego
Katowice, , Poland
Klinika Neurologii Akademii Medycznej w Lublinie
Lublin, , Poland
Centrum Medycne HCP sp.zo.o Dept. Neurlogy
Poznan, , Poland
Institute for Psychiatry and Neurology 2nd Neurology Dept.
Warsaw, , Poland
State Multiregional Clinical Diagnostical GU MKDZ
Kazan', , Russia
Central clinical Hospital of the President of the Russian Federation
Moscow, , Russia
Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia
Moscow, , Russia
Municipal Institution of Health City Clinical Hospital No. 1
Novosibirsk, , Russia
Hospital Baranov
Petrozavodsk, , Russia
Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"
Rostov-on-Don, , Russia
Multiprofile City Clinic No. 2
Saint Petersburg, , Russia
City Clinic Neurology N2 of Marinski Hospital
Saint Petersburg, , Russia
State Medical University named after IP Pavlov Leo Tolstoj
Saint Petersburg, , Russia
City Hospital Nr. 1 of Pirogov
Samara, , Russia
Jaroslav Regional Clinical Hospital State Institution of Healthcare
Yaroslavl, , Russia
City Clinical Hospital MU KGB Nr. 40
Yekaterinburg, , Russia
Fakultna nemocnica s poliklinikou Bratislava
Bratislava, , Slovakia
Vseobecna nemocnica s polokliniknikou Levoca a.s.
Levoča, , Slovakia
Martinska fakultna nemocnica
Martin, , Slovakia
Fakultna nemocnica Nitra
Nitra, , Slovakia
Fakultna nemocnica Nitra
Nitra, , Slovakia
Nemocnica s poliklinikou Spisska
Nová Ves, , Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana
Prestov, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
Clinical Projects Research
Worcester, , South Africa
Centre Hospitalier universitaire Vaudois, Dept. of Neurology
Lausanne, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Countries
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Related Links
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Related Info
Other Identifiers
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NTI-ASP-0503
Identifier Type: -
Identifier Source: org_study_id
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