ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
- Conditions
- StrokeCerebral IschemiaBrain Infarction
- Interventions
- Biological: Ancrod (Viprinex)Drug: Placebo
- Registration Number
- NCT00300196
- Lead Sponsor
- Neurobiological Technologies
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 311
- Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
- Baseline NIHSS > 5
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous ancrod Ancrod (Viprinex) 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. Intravenous Placebo Placebo Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
- Primary Outcome Measures
Name Time Method Modified Rankin Score - responder analysis 90 days
- Secondary Outcome Measures
Name Time Method Barthel Index, NIHSS 90 days
Trial Locations
- Locations (92)
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Bradenton Research Center
🇺🇸Bradenton, Florida, United States
Chattanooga Center for Neurologic Research
🇺🇸Chattanooga, Tennessee, United States
Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"
🇷🇺Rostov-on Don, Russian Federation
City Hospital Nr. 1 of Pirogov
🇷🇺Samara, Russian Federation
PalackyUniversity Faculty of Medicine and Dentistry and University Hospital
🇨🇿Olomouc, Czech Republic
Municipal Institution of Health City Clinical Hospital No. 1
🇷🇺Novosibirsk, Russian Federation
Hospital Baranov
🇷🇺Petrozawodsk, Russian Federation
State Medical University named after IP Pavlov Leo Tolstoj
🇷🇺St Petersburg, Russian Federation
Multiprofile City Clinic No. 2
🇷🇺St. Petersburg, Russian Federation
City Clinic Neurology N2 of Marinski Hospital
🇷🇺St. Petersburg, Russian Federation
Fakultna nemocnica s poliklinikou Bratislava
🇸🇰Bratislava, Slovakia
Nemocnica s poliklinikou Spisska
🇸🇰Nova Ves, Slovakia
Vseobecna nemocnica s polokliniknikou Levoca a.s.
🇸🇰Levoca, Slovakia
Martinska fakultna nemocnica
🇸🇰Martin, Slovakia
Fakultna nemocnica Nitra
🇸🇰Nitra, Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana
🇸🇰Prestov, Slovakia
Enloe Medical Center
🇺🇸Chico, California, United States
Sherry Braheny MD - A Prof. Corporation
🇺🇸La Mesa, California, United States
Central clinical Hospital of the President of the Russian Federation
🇷🇺Moscow, Russian Federation
Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia
🇷🇺Moscow, Russian Federation
Fakultna nemocnica Trnava
🇸🇰Trnava, Slovakia
Centre Hospitalier universitaire Vaudois, Dept. of Neurology
🇨🇭Lausanne, Switzerland
Clinical Projects Research
🇿🇦Worcester, South Africa
Universitatsspital Zurich
🇨🇭Zurich, Switzerland
Los Robles Hospital and Medical Center
🇺🇸Thousand Oaks, California, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
UCSF-Fresno
🇺🇸Fresno, California, United States
Suncoast Neuroscience Associates
🇺🇸St. Petersburg, Florida, United States
Collier Neurologic Specialists
🇺🇸Naples, Florida, United States
Joan Glancy Memorial Hospital
🇺🇸Duluth, Georgia, United States
Naples Community Hospital
🇺🇸Naples, Florida, United States
Melbourne Internal Medicine Associates
🇺🇸Melbourne, Florida, United States
Candler Hospital
🇺🇸Savannah, Georgia, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Saint Luke's Hospital Mid America Brain and Stroke Institute
🇺🇸Kansas City, Missouri, United States
Dekalb Medical Center-Hillandale
🇺🇸Lithonia, Georgia, United States
OSF Saint Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Bromenn Regional Medical Center
🇺🇸Normal, Illinois, United States
St. Joseph's Hospital
🇺🇸Savannah, Georgia, 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
Aultman Hospital
🇺🇸Canton, Ohio, United States
Five Towns Neuroscience Research
🇺🇸Lawrence, New York, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Lutheran Medical Center
🇺🇸Brooklyn, New York, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Neuroscience Institute St Francis Medical Center
🇺🇸Trenton, New Jersey, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Hahenmann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
Medical University of Affairs
🇦🇹Graz, Austria
Providence St. Peter Hospital
🇺🇸Olympia, Washington, United States
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
CAMC Memorial Hospital
🇺🇸Charleston, West Virginia, United States
St Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Gold Coast Hospital
🇦🇺Southport, Queensland, Australia
Alfred Hospital Research - Melbourne
🇦🇺Prahan, Melbourne, Victoria, Australia
Moash Medical Center Dept of Neurology
🇦🇺Clayton, Victoria, Australia
University Hospital Hradec Kralove Neurological Department
🇨🇿Hradec-Kralove, Czech Republic
Thomayer's Faculty Clinic of Neurology
🇨🇿Prague, Czech Republic
Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev
🇮🇱Beer Sheva, Israel
Rambam Medical Center Dept. of Neurology
🇮🇱Haifa, Israel
Concord Hospital Neuroscience Department
🇦🇺New South Wales, Australia
Neurologische Intensivstation
🇦🇹Linz, Austria
Regional Hospital Pardubice
🇨🇿Pardubice, Czech Republic
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Vitkovice Hospital Department of Neurology
🇨🇿Ostrava, Czech Republic
University Hospital Motol Department of Neurology
🇨🇿Prague, Czech Republic
General University Hospital Clinic of Neurology-Stroke Center
🇨🇿Prague, Czech Republic
Bnei-Zion Medical Center
🇮🇱Haifa, Israel
Wolfson Medical Center
🇮🇱Holon, Israel
Western Galilee Hospital Neurology Dept
🇮🇱Nahariya, Israel
Rabin Medical Center Golda Campus (Hasharon)
🇮🇱Petach Tikva, Israel
Hadassah Ein-Karem Medical Center
🇮🇱Jerusalem, Israel
Auckland City Hospital
🇳🇿Auckland, New Zealand
Tel-Aviv Medical Center
🇮🇱Tel Aviv, Israel
Chaim Sheba Medical Center Neurology Dept
🇮🇱Tel Hashomer, Israel
Katedra i Klinika Neurologii, Wieku Podesziego
🇵🇱Katowice, Poland
Cristchurch Hospitial
🇳🇿Christchurch, New Zealand
Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum
🇵🇱Gdansk, Poland
Klinika Neurologii Akademii Medycznej w Lublinie
🇵🇱Lublin, Poland
Centrum Medycne HCP sp.zo.o Dept. Neurlogy
🇵🇱Poznan, Poland
City Clinical Hospital MU KGB Nr. 40
🇷🇺Ekaterinburg, Russian Federation
Institute for Psychiatry and Neurology 2nd Neurology Dept.
🇵🇱Warsaw, Poland
Jaroslav Regional Clinical Hospital State Institution of Healthcare
🇷🇺Jaroslavl, Russian Federation
State Multiregional Clinical Diagnostical GU MKDZ
🇷🇺Kazan, Russian Federation