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

Primary Purpose

Stroke, Cerebral Ischemia, Brain Infarction

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ancrod (Viprinex)
Placebo
Sponsored by
Neurobiological Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Fibrinogen, Reperfusion, Thrombolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Enloe Medical Center
  • UCSF-Fresno
  • Sherry Braheny MD - A Prof. Corporation
  • Mercy General Hospital
  • Los Robles Hospital and Medical Center
  • Yale University School of Medicine
  • Manatee Memorial Hospital
  • Bradenton Research Center
  • Melbourne Internal Medicine Associates
  • Collier Neurologic Specialists
  • Naples Community Hospital
  • Suncoast Neuroscience Associates
  • Joan Glancy Memorial Hospital
  • Joan Glancy Memorial Hospital
  • Gwinnett Medical Center
  • Dekalb Medical Center-Hillandale
  • Candler Hospital
  • St. Joseph's Hospital
  • OSF Saint Joseph Medical Center
  • Bromenn Regional Medical Center
  • Bronson Methodist Hospital
  • Saint Luke's Hospital Mid America Brain and Stroke Institute
  • Research Medical Center
  • St. Louis University Hospital - Dept of Neurology
  • Nevada Neuroscience Institute at Sunrise
  • Jersey Shore University Medical Center
  • Neuroscience Institute St Francis Medical Center
  • Lutheran Medical Center
  • Five Towns Neuroscience Research
  • Aultman Hospital
  • Charles F. Kettering Memorial Hospital
  • Doylestown Hospital
  • Lancaster General Hospital
  • Hahenmann University Hospital
  • AnMed Health
  • Chattanooga Center for Neurologic Research
  • Overlake Hospital Medical Center
  • Providence St. Peter Hospital
  • CAMC Memorial Hospital
  • St Vincent's Hospital
  • Gold Coast Hospital
  • Moash Medical Center Dept of Neurology
  • Royal Melbourne Hospital
  • Alfred Hospital Research - Melbourne
  • Concord Hospital Neuroscience Department
  • Medical University of Affairs
  • Neurologische Intensivstation
  • University Hospital Hradec Kralove Neurological Department
  • PalackyUniversity Faculty of Medicine and Dentistry and University Hospital
  • Vitkovice Hospital Department of Neurology
  • Regional Hospital Pardubice
  • General University Hospital Clinic of Neurology-Stroke Center
  • Thomayer's Faculty Clinic of Neurology
  • University Hospital Motol Department of Neurology
  • Barzilai Medical Center
  • Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev
  • Bnei-Zion Medical Center
  • Rambam Medical Center Dept. of Neurology
  • Wolfson Medical Center
  • Hadassah Ein-Karem Medical Center
  • Western Galilee Hospital Neurology Dept
  • Rabin Medical Center Golda Campus (Hasharon)
  • Tel-Aviv Medical Center
  • Chaim Sheba Medical Center Neurology Dept
  • Auckland City Hospital
  • Cristchurch Hospitial
  • Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum
  • Katedra i Klinika Neurologii, Wieku Podesziego
  • Klinika Neurologii Akademii Medycznej w Lublinie
  • Centrum Medycne HCP sp.zo.o Dept. Neurlogy
  • Institute for Psychiatry and Neurology 2nd Neurology Dept.
  • City Clinical Hospital MU KGB Nr. 40
  • Jaroslav Regional Clinical Hospital State Institution of Healthcare
  • State Multiregional Clinical Diagnostical GU MKDZ
  • Central clinical Hospital of the President of the Russian Federation
  • Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia
  • Municipal Institution of Health City Clinical Hospital No. 1
  • Hospital Baranov
  • Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"
  • City Hospital Nr. 1 of Pirogov
  • State Medical University named after IP Pavlov Leo Tolstoj
  • Multiprofile City Clinic No. 2
  • City Clinic Neurology N2 of Marinski Hospital
  • Fakultna nemocnica s poliklinikou Bratislava
  • Vseobecna nemocnica s polokliniknikou Levoca a.s.
  • Martinska fakultna nemocnica
  • Fakultna nemocnica Nitra
  • Fakultna nemocnica Nitra
  • Nemocnica s poliklinikou Spisska
  • Fakultna nemocnica s poliklinikou J.A. Reimana
  • Fakultna nemocnica Trnava
  • Clinical Projects Research
  • Centre Hospitalier universitaire Vaudois, Dept. of Neurology
  • Universitatsspital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous ancrod

Intravenous Placebo

Arm Description

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 at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.

Outcomes

Primary Outcome Measures

Modified Rankin Score - responder analysis

Secondary Outcome Measures

Barthel Index, NIHSS

Full Information

First Posted
March 6, 2006
Last Updated
January 11, 2010
Sponsor
Neurobiological Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT00300196
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neurobiological Technologies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Ischemia, Brain Infarction
Keywords
Stroke, Fibrinogen, Reperfusion, Thrombolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous ancrod
Arm Type
Experimental
Arm Description
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.
Arm Title
Intravenous Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
Intervention Type
Biological
Intervention Name(s)
Ancrod (Viprinex)
Intervention Description
0.167 IU/kg/hr IV for 2-3 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.6 mL/kg/hr
Primary Outcome Measure Information:
Title
Modified Rankin Score - responder analysis
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Barthel Index, NIHSS
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Wasiewski, M.D.
Organizational Affiliation
Neurobiological Technologies
Official's Role
Study Director
Facility Information:
Facility Name
Enloe Medical Center
City
Chico
State/Province
California
ZIP/Postal Code
95973
Country
United States
Facility Name
UCSF-Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Sherry Braheny MD - A Prof. Corporation
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Los Robles Hospital and Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Manatee Memorial Hospital
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34250
Country
United States
Facility Name
Melbourne Internal Medicine Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Collier Neurologic Specialists
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Naples Community Hospital
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Suncoast Neuroscience Associates
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Joan Glancy Memorial Hospital
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Joan Glancy Memorial Hospital
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Gwinnett Medical Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Dekalb Medical Center-Hillandale
City
Lithonia
State/Province
Georgia
ZIP/Postal Code
30058
Country
United States
Facility Name
Candler Hospital
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
St. Joseph's Hospital
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Facility Name
OSF Saint Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Bromenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Saint Luke's Hospital Mid America Brain and Stroke Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
St. Louis University Hospital - Dept of Neurology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Neuroscience Institute at Sunrise
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Neuroscience Institute St Francis Medical Center
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08629
Country
United States
Facility Name
Lutheran Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Five Towns Neuroscience Research
City
Lawrence
State/Province
New York
ZIP/Postal Code
11559
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
Hahenmann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1101
Country
United States
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Chattanooga Center for Neurologic Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
97401
Country
United States
Facility Name
Overlake Hospital Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Providence St. Peter Hospital
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506
Country
United States
Facility Name
CAMC Memorial Hospital
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
St Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Gold Coast Hospital
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
Moash Medical Center Dept of Neurology
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Alfred Hospital Research - Melbourne
City
Prahan, Melbourne
State/Province
Victoria
ZIP/Postal Code
3184
Country
Australia
Facility Name
Concord Hospital Neuroscience Department
City
New South Wales
Country
Australia
Facility Name
Medical University of Affairs
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Neurologische Intensivstation
City
Linz
ZIP/Postal Code
A4020
Country
Austria
Facility Name
University Hospital Hradec Kralove Neurological Department
City
Hradec-Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
PalackyUniversity Faculty of Medicine and Dentistry and University Hospital
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Vitkovice Hospital Department of Neurology
City
Ostrava
ZIP/Postal Code
703 84
Country
Czech Republic
Facility Name
Regional Hospital Pardubice
City
Pardubice
ZIP/Postal Code
53 203
Country
Czech Republic
Facility Name
General University Hospital Clinic of Neurology-Stroke Center
City
Prague
ZIP/Postal Code
12000
Country
Czech Republic
Facility Name
Thomayer's Faculty Clinic of Neurology
City
Prague
ZIP/Postal Code
14059
Country
Czech Republic
Facility Name
University Hospital Motol Department of Neurology
City
Prague
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev
City
Beer Sheva
ZIP/Postal Code
84105
Country
Israel
Facility Name
Bnei-Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center Dept. of Neurology
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Hadassah Ein-Karem Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Western Galilee Hospital Neurology Dept
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center Golda Campus (Hasharon)
City
Petach Tikva
ZIP/Postal Code
49372
Country
Israel
Facility Name
Tel-Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chaim Sheba Medical Center Neurology Dept
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1001
Country
New Zealand
Facility Name
Cristchurch Hospitial
City
Christchurch
ZIP/Postal Code
4710
Country
New Zealand
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum
City
Gdansk
ZIP/Postal Code
80294
Country
Poland
Facility Name
Katedra i Klinika Neurologii, Wieku Podesziego
City
Katowice
ZIP/Postal Code
40752
Country
Poland
Facility Name
Klinika Neurologii Akademii Medycznej w Lublinie
City
Lublin
ZIP/Postal Code
20090
Country
Poland
Facility Name
Centrum Medycne HCP sp.zo.o Dept. Neurlogy
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Institute for Psychiatry and Neurology 2nd Neurology Dept.
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
City Clinical Hospital MU KGB Nr. 40
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Jaroslav Regional Clinical Hospital State Institution of Healthcare
City
Jaroslavl
Country
Russian Federation
Facility Name
State Multiregional Clinical Diagnostical GU MKDZ
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Central clinical Hospital of the President of the Russian Federation
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia
City
Moscow
Country
Russian Federation
Facility Name
Municipal Institution of Health City Clinical Hospital No. 1
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Hospital Baranov
City
Petrozawodsk
Country
Russian Federation
Facility Name
Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"
City
Rostov-on Don
ZIP/Postal Code
344011
Country
Russian Federation
Facility Name
City Hospital Nr. 1 of Pirogov
City
Samara
ZIP/Postal Code
443096
Country
Russian Federation
Facility Name
State Medical University named after IP Pavlov Leo Tolstoj
City
St Petersburg
Country
Russian Federation
Facility Name
Multiprofile City Clinic No. 2
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
City Clinic Neurology N2 of Marinski Hospital
City
St. Petersburg
Country
Russian Federation
Facility Name
Fakultna nemocnica s poliklinikou Bratislava
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Vseobecna nemocnica s polokliniknikou Levoca a.s.
City
Levoca
ZIP/Postal Code
05401
Country
Slovakia
Facility Name
Martinska fakultna nemocnica
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
Fakultna nemocnica Nitra
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Fakultna nemocnica Nitra
City
Nitra
ZIP/Postal Code
95001
Country
Slovakia
Facility Name
Nemocnica s poliklinikou Spisska
City
Nova Ves
ZIP/Postal Code
05201
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou J.A. Reimana
City
Prestov
ZIP/Postal Code
08181
Country
Slovakia
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
91775
Country
Slovakia
Facility Name
Clinical Projects Research
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Centre Hospitalier universitaire Vaudois, Dept. of Neurology
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
CH8091
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.ntii.com
Description
Related Info

Learn more about this trial

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

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