Study Stopped
Futility
ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
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
1 other identifier
interventional
311
10 countries
92
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 stroke
Started Mar 2006
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 6, 2006
CompletedFirst Posted
Study publicly available on registry
March 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 12, 2010
January 1, 2010
2.8 years
March 6, 2006
January 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Rankin Score - responder analysis
90 days
Secondary Outcomes (1)
Barthel Index, NIHSS
90 days
Study Arms (2)
Intravenous ancrod
EXPERIMENTALIntravenous 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.
Intravenous Placebo
PLACEBO COMPARATORIntravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
Interventions
Eligibility Criteria
You may qualify if:
- Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
- Baseline NIHSS \> 5
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Enloe Medical Center
Chico, California, 95973, United States
UCSF-Fresno
Fresno, California, 93701, United States
Sherry Braheny MD - A Prof. Corporation
La Mesa, California, 91942, United States
Mercy General Hospital
Sacramento, California, 95825, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Manatee Memorial Hospital
Bradenton, Florida, 34208, United States
Bradenton Research Center
Bradenton, Florida, 34250, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, 32901, United States
Collier Neurologic Specialists
Naples, Florida, 34102, United States
Naples Community Hospital
Naples, Florida, 34102, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, 33701, United States
Joan Glancy Memorial Hospital
Decatur, Georgia, 30033, United States
Joan Glancy Memorial Hospital
Duluth, Georgia, 30096, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
Dekalb Medical Center-Hillandale
Lithonia, Georgia, 30058, United States
Candler Hospital
Savannah, Georgia, 31405, United States
St. Joseph's Hospital
Savannah, Georgia, 31419, United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Saint Luke's Hospital Mid America Brain and Stroke Institute
Kansas City, Missouri, 64111, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
St. Louis University Hospital - Dept of Neurology
St Louis, Missouri, 63110, United States
Nevada Neuroscience Institute at Sunrise
Las Vegas, Nevada, 89109, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Neuroscience Institute St Francis Medical Center
Trenton, New Jersey, 08629, United States
Lutheran Medical Center
Brooklyn, New York, 11220, United States
Five Towns Neuroscience Research
Lawrence, New York, 11559, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17603, United States
Hahenmann University Hospital
Philadelphia, Pennsylvania, 19102-1101, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 97401, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
Providence St. Peter Hospital
Olympia, Washington, 98506, United States
CAMC Memorial Hospital
Charleston, West Virginia, 25304, United States
St Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Gold Coast Hospital
Southport, Queensland, Australia
Moash Medical Center Dept of Neurology
Clayton, Victoria, 3168, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Alfred Hospital Research - Melbourne
Prahan, Melbourne, Victoria, 3184, Australia
Concord Hospital Neuroscience Department
New South Wales, Australia
Medical University of Affairs
Graz, 8036, Austria
Neurologische Intensivstation
Linz, A4020, Austria
University Hospital Hradec Kralove Neurological Department
Hradec Králové, 500 05, Czechia
PalackyUniversity Faculty of Medicine and Dentistry and University Hospital
Olomouc, 77520, Czechia
Vitkovice Hospital Department of Neurology
Ostrava, 703 84, Czechia
Regional Hospital Pardubice
Pardubice, 53 203, Czechia
General University Hospital Clinic of Neurology-Stroke Center
Prague, 12000, Czechia
Thomayer's Faculty Clinic of Neurology
Prague, 14059, Czechia
University Hospital Motol Department of Neurology
Prague, 15006, Czechia
Barzilai Medical Center
Ashkelon, 78306, Israel
Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev
Beersheba, 84105, Israel
Bnei-Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center Dept. of Neurology
Haifa, 31096, Israel
Wolfson Medical Center
Holon, 58100, Israel
Hadassah Ein-Karem Medical Center
Jerusalem, 91120, Israel
Western Galilee Hospital Neurology Dept
Nahariya, 22100, Israel
Rabin Medical Center Golda Campus (Hasharon)
Petah Tikva, 49372, Israel
Tel-Aviv Medical Center
Tel Aviv, 64239, Israel
Chaim Sheba Medical Center Neurology Dept
Tel Litwinsky, 52621, Israel
Auckland City Hospital
Auckland, 1001, New Zealand
Cristchurch Hospitial
Christchurch, 4710, New Zealand
Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum
Gdansk, 80294, Poland
Katedra i Klinika Neurologii, Wieku Podesziego
Katowice, 40752, Poland
Klinika Neurologii Akademii Medycznej w Lublinie
Lublin, 20090, Poland
Centrum Medycne HCP sp.zo.o Dept. Neurlogy
Poznan, 61-485, Poland
Institute for Psychiatry and Neurology 2nd Neurology Dept.
Warsaw, 02-957, Poland
State Multiregional Clinical Diagnostical GU MKDZ
Kazan', 420101, Russia
Central clinical Hospital of the President of the Russian Federation
Moscow, 121359, Russia
Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia
Moscow, Russia
Municipal Institution of Health City Clinical Hospital No. 1
Novosibirsk, 630047, Russia
Hospital Baranov
Petrozavodsk, Russia
Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"
Rostov-on-Don, 344011, Russia
Multiprofile City Clinic No. 2
Saint Petersburg, 194354, 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, 443096, Russia
Jaroslav Regional Clinical Hospital State Institution of Healthcare
Yaroslavl, Russia
City Clinical Hospital MU KGB Nr. 40
Yekaterinburg, 620102, Russia
Fakultna nemocnica s poliklinikou Bratislava
Bratislava, 81369, Slovakia
Vseobecna nemocnica s polokliniknikou Levoca a.s.
Levoča, 05401, Slovakia
Martinska fakultna nemocnica
Martin, 03659, Slovakia
Fakultna nemocnica Nitra
Nitra, 949 01, Slovakia
Fakultna nemocnica Nitra
Nitra, 95001, Slovakia
Nemocnica s poliklinikou Spisska
Nová Ves, 05201, Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana
Prestov, 08181, Slovakia
Fakultna nemocnica Trnava
Trnava, 91775, Slovakia
Clinical Projects Research
Worcester, 6850, South Africa
Centre Hospitalier universitaire Vaudois, Dept. of Neurology
Lausanne, 1011, Switzerland
Universitatsspital Zurich
Zurich, CH8091, Switzerland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Warren Wasiewski, M.D.
Neurobiological Technologies
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 6, 2006
First Posted
March 8, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 12, 2010
Record last verified: 2010-01