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

NCT ID: NCT00300196

Last Updated: 2010-01-12

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Stroke Cerebral Ischemia Brain Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Ancrod (Viprinex)

Intervention Type BIOLOGICAL

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.6 mL/kg/hr

Interventions

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Ancrod (Viprinex)

0.167 IU/kg/hr IV for 2-3 hours

Intervention Type BIOLOGICAL

Placebo

0.6 mL/kg/hr

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurobiological Technologies

INDUSTRY

Sponsor Role lead

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

Site Status

UCSF-Fresno

Fresno, California, United States

Site Status

Sherry Braheny MD - A Prof. Corporation

La Mesa, California, United States

Site Status

Mercy General Hospital

Sacramento, California, United States

Site Status

Los Robles Hospital and Medical Center

Thousand Oaks, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Manatee Memorial Hospital

Bradenton, Florida, United States

Site Status

Bradenton Research Center

Bradenton, Florida, United States

Site Status

Melbourne Internal Medicine Associates

Melbourne, Florida, United States

Site Status

Collier Neurologic Specialists

Naples, Florida, United States

Site Status

Naples Community Hospital

Naples, Florida, United States

Site Status

Suncoast Neuroscience Associates

St. Petersburg, Florida, United States

Site Status

Joan Glancy Memorial Hospital

Decatur, Georgia, United States

Site Status

Joan Glancy Memorial Hospital

Duluth, Georgia, United States

Site Status

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Site Status

Dekalb Medical Center-Hillandale

Lithonia, Georgia, United States

Site Status

Candler Hospital

Savannah, Georgia, United States

Site Status

St. Joseph's Hospital

Savannah, Georgia, United States

Site Status

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

Saint Luke's Hospital Mid America Brain and Stroke Institute

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

St. Louis University Hospital - Dept of Neurology

St Louis, Missouri, United States

Site Status

Nevada Neuroscience Institute at Sunrise

Las Vegas, Nevada, United States

Site Status

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Site Status

Neuroscience Institute St Francis Medical Center

Trenton, New Jersey, United States

Site Status

Lutheran Medical Center

Brooklyn, New York, United States

Site Status

Five Towns Neuroscience Research

Lawrence, New York, United States

Site Status

Aultman Hospital

Canton, Ohio, United States

Site Status

Charles F. Kettering Memorial Hospital

Kettering, Ohio, United States

Site Status

Doylestown Hospital

Doylestown, Pennsylvania, United States

Site Status

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status

Hahenmann University Hospital

Philadelphia, Pennsylvania, United States

Site Status

AnMed Health

Anderson, South Carolina, United States

Site Status

Chattanooga Center for Neurologic Research

Chattanooga, Tennessee, United States

Site Status

Overlake Hospital Medical Center

Bellevue, Washington, United States

Site Status

Providence St. Peter Hospital

Olympia, Washington, United States

Site Status

CAMC Memorial Hospital

Charleston, West Virginia, United States

Site Status

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status

Gold Coast Hospital

Southport, Queensland, Australia

Site Status

Moash Medical Center Dept of Neurology

Clayton, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Alfred Hospital Research - Melbourne

Prahan, Melbourne, Victoria, Australia

Site Status

Concord Hospital Neuroscience Department

New South Wales, , Australia

Site Status

Medical University of Affairs

Graz, , Austria

Site Status

Neurologische Intensivstation

Linz, , Austria

Site Status

University Hospital Hradec Kralove Neurological Department

Hradec Králové, , Czechia

Site Status

PalackyUniversity Faculty of Medicine and Dentistry and University Hospital

Olomouc, , Czechia

Site Status

Vitkovice Hospital Department of Neurology

Ostrava, , Czechia

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Regional Hospital Pardubice

Pardubice, , Czechia

Site Status

General University Hospital Clinic of Neurology-Stroke Center

Prague, , Czechia

Site Status

Thomayer's Faculty Clinic of Neurology

Prague, , Czechia

Site Status

University Hospital Motol Department of Neurology

Prague, , Czechia

Site Status

Barzilai Medical Center

Ashkelon, , Israel

Site Status

Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev

Beersheba, , Israel

Site Status

Bnei-Zion Medical Center

Haifa, , Israel

Site Status

Rambam Medical Center Dept. of Neurology

Haifa, , Israel

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Wolfson Medical Center

Holon, , Israel

Site Status

Hadassah Ein-Karem Medical Center

Jerusalem, , Israel

Site Status

Western Galilee Hospital Neurology Dept

Nahariya, , Israel

Site Status

Rabin Medical Center Golda Campus (Hasharon)

Petah Tikva, , Israel

Site Status

Tel-Aviv Medical Center

Tel Aviv, , Israel

Site Status

Chaim Sheba Medical Center Neurology Dept

Tel Litwinsky, , Israel

Site Status

Auckland City Hospital

Auckland, , New Zealand

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Cristchurch Hospitial

Christchurch, , New Zealand

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Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum

Gdansk, , Poland

Site Status

Katedra i Klinika Neurologii, Wieku Podesziego

Katowice, , Poland

Site Status

Klinika Neurologii Akademii Medycznej w Lublinie

Lublin, , Poland

Site Status

Centrum Medycne HCP sp.zo.o Dept. Neurlogy

Poznan, , Poland

Site Status

Institute for Psychiatry and Neurology 2nd Neurology Dept.

Warsaw, , Poland

Site Status

State Multiregional Clinical Diagnostical GU MKDZ

Kazan', , Russia

Site Status

Central clinical Hospital of the President of the Russian Federation

Moscow, , Russia

Site Status

Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia

Moscow, , Russia

Site Status

Municipal Institution of Health City Clinical Hospital No. 1

Novosibirsk, , Russia

Site Status

Hospital Baranov

Petrozavodsk, , Russia

Site Status

Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"

Rostov-on-Don, , Russia

Site Status

Multiprofile City Clinic No. 2

Saint Petersburg, , Russia

Site Status

City Clinic Neurology N2 of Marinski Hospital

Saint Petersburg, , Russia

Site Status

State Medical University named after IP Pavlov Leo Tolstoj

Saint Petersburg, , Russia

Site Status

City Hospital Nr. 1 of Pirogov

Samara, , Russia

Site Status

Jaroslav Regional Clinical Hospital State Institution of Healthcare

Yaroslavl, , Russia

Site Status

City Clinical Hospital MU KGB Nr. 40

Yekaterinburg, , Russia

Site Status

Fakultna nemocnica s poliklinikou Bratislava

Bratislava, , Slovakia

Site Status

Vseobecna nemocnica s polokliniknikou Levoca a.s.

Levoča, , Slovakia

Site Status

Martinska fakultna nemocnica

Martin, , Slovakia

Site Status

Fakultna nemocnica Nitra

Nitra, , Slovakia

Site Status

Fakultna nemocnica Nitra

Nitra, , Slovakia

Site Status

Nemocnica s poliklinikou Spisska

Nová Ves, , Slovakia

Site Status

Fakultna nemocnica s poliklinikou J.A. Reimana

Prestov, , Slovakia

Site Status

Fakultna nemocnica Trnava

Trnava, , Slovakia

Site Status

Clinical Projects Research

Worcester, , South Africa

Site Status

Centre Hospitalier universitaire Vaudois, Dept. of Neurology

Lausanne, , Switzerland

Site Status

Universitatsspital Zurich

Zurich, , Switzerland

Site Status

Countries

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United States Australia Austria Czechia Israel New Zealand Poland Russia Slovakia South Africa Switzerland

Related Links

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Other Identifiers

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NTI-ASP-0503

Identifier Type: -

Identifier Source: org_study_id

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