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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00300196
• Other study ID #: NTI-ASP-0503
• Status: Terminated
• Phase: Phase 3
• First received: March 6, 2006
• Last updated: January 11, 2010
• Start date: March 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2010
• Source: Neurobiological Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 311
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Brain Infarction
• Cerebral Infarction
• Cerebral Ischemia
• Stroke

Intervention

Biological:
• Ancrod (Viprinex)
0.167 IU/kg/hr IV for 2-3 hours

Drug:
• Placebo
0.6 mL/kg/hr

Locations

Country	Name	City	State
Australia	Moash Medical Center Dept of Neurology	Clayton	Victoria
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Concord Hospital Neuroscience Department	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Alfred Hospital Research - Melbourne	Prahan, Melbourne	Victoria
Australia	Gold Coast Hospital	Southport	Queensland
Austria	Medical University of Affairs	Graz
Austria	Neurologische Intensivstation	Linz
Czech Republic	University Hospital Hradec Kralove Neurological Department	Hradec-Kralove
Czech Republic	PalackyUniversity Faculty of Medicine and Dentistry and University Hospital	Olomouc
Czech Republic	Vitkovice Hospital Department of Neurology	Ostrava
Czech Republic	Regional Hospital Pardubice	Pardubice
Czech Republic	General University Hospital Clinic of Neurology-Stroke Center	Prague
Czech Republic	Thomayer's Faculty Clinic of Neurology	Prague
Czech Republic	University Hospital Motol Department of Neurology	Prague
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev	Beer Sheva
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)	Petach Tikva
Israel	Tel-Aviv Medical Center	Tel Aviv
Israel	Chaim Sheba Medical Center Neurology Dept	Tel Hashomer
New Zealand	Auckland City Hospital	Auckland
New Zealand	Cristchurch Hospitial	Christchurch
Poland	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
Russian Federation	City Clinical Hospital MU KGB Nr. 40	Ekaterinburg
Russian Federation	Jaroslav Regional Clinical Hospital State Institution of Healthcare	Jaroslavl
Russian Federation	State Multiregional Clinical Diagnostical GU MKDZ	Kazan
Russian Federation	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	Municipal Institution of Health City Clinical Hospital No. 1	Novosibirsk
Russian Federation	Hospital Baranov	Petrozawodsk
Russian Federation	Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"	Rostov-on Don
Russian Federation	City Hospital Nr. 1 of Pirogov	Samara
Russian Federation	State Medical University named after IP Pavlov Leo Tolstoj	St Petersburg
Russian Federation	City Clinic Neurology N2 of Marinski Hospital	St. Petersburg
Russian Federation	Multiprofile City Clinic No. 2	St. Petersburg
Slovakia	Fakultna nemocnica s poliklinikou Bratislava	Bratislava
Slovakia	Vseobecna nemocnica s polokliniknikou Levoca a.s.	Levoca
Slovakia	Martinska fakultna nemocnica	Martin
Slovakia	Fakultna nemocnica Nitra	Nitra
Slovakia	Fakultna nemocnica Nitra	Nitra
Slovakia	Nemocnica s poliklinikou Spisska	Nova Ves
Slovakia	Fakultna nemocnica s poliklinikou J.A. Reimana	Prestov
Slovakia	Fakultna nemocnica Trnava	Trnava
South Africa	Clinical Projects Research	Worcester
Switzerland	Centre Hospitalier universitaire Vaudois, Dept. of Neurology	Lausanne
Switzerland	Universitatsspital Zurich	Zurich
United States	AnMed Health	Anderson	South Carolina
United States	Overlake Hospital Medical Center	Bellevue	Washington
United States	OSF Saint Joseph Medical Center	Bloomington	Illinois
United States	Bradenton Research Center	Bradenton	Florida
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	Lutheran Medical Center	Brooklyn	New York
United States	Aultman Hospital	Canton	Ohio
United States	CAMC Memorial Hospital	Charleston	West Virginia
United States	Chattanooga Center for Neurologic Research	Chattanooga	Tennessee
United States	Enloe Medical Center	Chico	California
United States	Joan Glancy Memorial Hospital	Decatur	Georgia
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Joan Glancy Memorial Hospital	Duluth	Georgia
United States	UCSF-Fresno	Fresno	California
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Luke's Hospital Mid America Brain and Stroke Institute	Kansas City	Missouri
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Sherry Braheny MD - A Prof. Corporation	La Mesa	California
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Nevada Neuroscience Institute at Sunrise	Las Vegas	Nevada
United States	Five Towns Neuroscience Research	Lawrence	New York
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Dekalb Medical Center-Hillandale	Lithonia	Georgia
United States	Melbourne Internal Medicine Associates	Melbourne	Florida
United States	Collier Neurologic Specialists	Naples	Florida
United States	Naples Community Hospital	Naples	Florida
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Bromenn Regional Medical Center	Normal	Illinois
United States	Providence St. Peter Hospital	Olympia	Washington
United States	Hahenmann University Hospital	Philadelphia	Pennsylvania
United States	Mercy General Hospital	Sacramento	California
United States	Candler Hospital	Savannah	Georgia
United States	St. Joseph's Hospital	Savannah	Georgia
United States	St. Louis University Hospital - Dept of Neurology	St. Louis	Missouri
United States	Suncoast Neuroscience Associates	St. Petersburg	Florida
United States	Los Robles Hospital and Medical Center	Thousand Oaks	California
United States	Neuroscience Institute St Francis Medical Center	Trenton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Neurobiological Technologies

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Czech Republic,  Israel,  New Zealand,  Poland,  Russian Federation,  Slovakia,  South Africa,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Score - responder analysis		90 days	No
Secondary	Barthel Index, NIHSS		90 days	No

External Links

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