Clinical trial NCT00300196: ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stroke
Cerebral Ischemia
Brain Infarction
Keywords: Stroke
Fibrinogen
Reperfusion
Thrombolysis
Lead sponsor: Neurobiological Technologies
Sponsor class: INDUSTRY
First posted: 2006-03-08
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Modified Rankin Score - responder analysis
timeFrame: 90 days
Secondary outcomes:
measure: Barthel Index, NIHSS
timeFrame: 90 days
Other outcomes:
Locations:
city: Chico
country: United States
facility: Enloe Medical Center
state: California
city: Fresno
country: United States
facility: UCSF-Fresno
state: California
city: La Mesa
country: United States
facility: Sherry Braheny MD - A Prof. Corporation
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital and Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: St. Petersburg
country: United States
facility: Suncoast Neuroscience Associates
state: Florida
city: Decatur
country: United States
facility: Joan Glancy Memorial Hospital
state: Georgia
city: Duluth
country: United States
facility: Joan Glancy Memorial Hospital
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Lithonia
country: United States
facility: Dekalb Medical Center-Hillandale
state: Georgia
city: Savannah
country: United States
facility: Candler Hospital
state: Georgia
city: Savannah
country: United States
facility: St. Joseph's Hospital
state: Georgia
city: Bloomington
country: United States
facility: OSF Saint Joseph Medical Center
state: Illinois
city: Normal
country: United States
facility: Bromenn Regional Medical Center
state: Illinois
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital Mid America Brain and Stroke Institute
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University Hospital - Dept of Neurology
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Neuroscience Institute at Sunrise
state: Nevada
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Trenton
country: United States
facility: Neuroscience Institute St Francis Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: Lutheran Medical Center
state: New York
city: Lawrence
country: United States
facility: Five Towns Neuroscience Research
state: New York
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Kettering
country: United States
facility: Charles F. Kettering Memorial Hospital
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahenmann University Hospital
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Center for Neurologic Research
state: Tennessee
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Olympia
country: United States
facility: Providence St. Peter Hospital
state: Washington
city: Charleston
country: United States
facility: CAMC Memorial Hospital
state: West Virginia
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast Hospital
state: Queensland
city: Clayton
country: Australia
facility: Moash Medical Center Dept of Neurology
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Prahan, Melbourne
country: Australia
facility: Alfred Hospital Research - Melbourne
state: Victoria
city: New South Wales
country: Australia
facility: Concord Hospital Neuroscience Department
city: Graz
country: Austria
facility: Medical University of Affairs
city: Linz
country: Austria
facility: Neurologische Intensivstation
city: Hradec-Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove Neurological Department
city: Olomouc
country: Czech Republic
facility: PalackyUniversity Faculty of Medicine and Dentistry and University Hospital
city: Ostrava
country: Czech Republic
facility: Vitkovice Hospital Department of Neurology
city: Pardubice
country: Czech Republic
facility: Regional Hospital Pardubice
city: Prague
country: Czech Republic
facility: General University Hospital Clinic of Neurology-Stroke Center
city: Prague
country: Czech Republic
facility: Thomayer's Faculty Clinic of Neurology
city: Prague
country: Czech Republic
facility: University Hospital Motol Department of Neurology
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Sheva
country: Israel
facility: Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev
city: Haifa
country: Israel
facility: Bnei-Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center Dept. of Neurology
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein-Karem Medical Center
city: Nahariya
country: Israel
facility: Western Galilee Hospital Neurology Dept
city: Petach Tikva
country: Israel
facility: Rabin Medical Center Golda Campus (Hasharon)
city: Tel Aviv
country: Israel
facility: Tel-Aviv Medical Center
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center Neurology Dept
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Cristchurch Hospitial
city: Gdansk
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum
city: Katowice
country: Poland
facility: Katedra i Klinika Neurologii, Wieku Podesziego
city: Lublin
country: Poland
facility: Klinika Neurologii Akademii Medycznej w Lublinie
city: Poznan
country: Poland
facility: Centrum Medycne HCP sp.zo.o Dept. Neurlogy
city: Warsaw
country: Poland
facility: Institute for Psychiatry and Neurology 2nd Neurology Dept.
city: Ekaterinburg
country: Russian Federation
facility: City Clinical Hospital MU KGB Nr. 40
city: Jaroslavl
country: Russian Federation
facility: Jaroslav Regional Clinical Hospital State Institution of Healthcare
city: Kazan
country: Russian Federation
facility: State Multiregional Clinical Diagnostical GU MKDZ
city: Moscow
country: Russian Federation
facility: Central clinical Hospital of the President of the Russian Federation
city: Moscow
country: Russian Federation
facility: Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia
city: Novosibirsk
country: Russian Federation
facility: Municipal Institution of Health City Clinical Hospital No. 1
city: Petrozawodsk
country: Russian Federation
facility: Hospital Baranov
city: Rostov-on Don
country: Russian Federation
facility: Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"
city: Samara
country: Russian Federation
facility: City Hospital Nr. 1 of Pirogov
city: St Petersburg
country: Russian Federation
facility: State Medical University named after IP Pavlov Leo Tolstoj
city: St. Petersburg
country: Russian Federation
facility: Multiprofile City Clinic No. 2
city: St. Petersburg
country: Russian Federation
facility: City Clinic Neurology N2 of Marinski Hospital
city: Bratislava
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Bratislava
city: Levoca
country: Slovakia
facility: Vseobecna nemocnica s polokliniknikou Levoca a.s.
city: Martin
country: Slovakia
facility: Martinska fakultna nemocnica
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Nova Ves
country: Slovakia
facility: Nemocnica s poliklinikou Spisska
city: Prestov
country: Slovakia
facility: Fakultna nemocnica s poliklinikou J.A. Reimana
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Worcester
country: South Africa
facility: Clinical Projects Research
city: Lausanne
country: Switzerland
facility: Centre Hospitalier universitaire Vaudois, Dept. of Neurology
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
Study officials:
affiliation: Neurobiological Technologies
name: Warren Wasiewski, M.D.
role: STUDY_DIRECTOR
References: