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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00141011




Registration number
NCT00141011
Ethics application status
Date submitted
30/08/2005
Date registered
1/09/2005
Date last updated
23/12/2009

Titles & IDs
Public title
Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
Scientific title
ASP I (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
Secondary ID [1] 0 0
NTI-ASP-0502
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Cerebral Ischemia 0 0
Brain Infarction 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ancrod (Viprinex)
Treatment: Drugs - Placebo

Experimental: 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.

Placebo Comparator: Intravenous Placebo - Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.


Treatment: Drugs: Ancrod (Viprinex)
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours

Treatment: Drugs: Placebo
0.6 mL/kg/hr

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Responder analysis based on Modified Rankin Scale (mRS)
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx
Timepoint [1] 0 0
90 days

Eligibility
Key inclusion criteria
- Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment

- Baseline NIHSS > 5
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Gosford Hospital Department of Neurology - Gosford
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
National Stroke Research Institute - Heidelberg Heights
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
- Box Hill
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg Heights
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Montana
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United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Pennsylvania
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Rhode Island
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
State/province [24] 0 0
Washington
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United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
Newfoundland and Labrador
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Edmonton
Country [31] 0 0
Canada
State/province [31] 0 0
Thunder Bay
Country [32] 0 0
Czech Republic
State/province [32] 0 0
Brno
Country [33] 0 0
Czech Republic
State/province [33] 0 0
Pilsen
Country [34] 0 0
Netherlands
State/province [34] 0 0
Geldrop
Country [35] 0 0
Poland
State/province [35] 0 0
Warsaw
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Russian Federation
State/province [36] 0 0
Moscow
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Russian Federation
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St. Petersburg
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South Africa
State/province [38] 0 0
Kwazulu Natal
Country [39] 0 0
South Africa
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Cape Town
Country [40] 0 0
South Africa
State/province [40] 0 0
Somerset West
Country [41] 0 0
South Africa
State/province [41] 0 0
Sunninghill
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Taiwan
State/province [42] 0 0
Changhua
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Taiwan
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IIan
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
State/province [48] 0 0
Taipei
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Taiwan
State/province [49] 0 0
Taoyuang
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United Kingdom
State/province [50] 0 0
Aberdeen
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United Kingdom
State/province [51] 0 0
Glasgow
Country [52] 0 0
United Kingdom
State/province [52] 0 0
New Castle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Neurobiological Technologies
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00141011
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Warren Wasiewski, M.D.
Address 0 0
Neurobiological Technologies
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00141011