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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00300196




Registration number
NCT00300196
Ethics application status
Date submitted
6/03/2006
Date registered
8/03/2006
Date last updated
12/01/2010

Titles & IDs
Public title
ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
Scientific 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
Secondary ID [1] 0 0
NTI-ASP-0503
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: Other - 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: Other: Ancrod (Viprinex)
0.167 IU/kg/hr IV for 2-3 hours

Treatment: Drugs: Placebo
0.6 mL/kg/hr
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Rankin Score - responder analysis
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Barthel Index, NIHSS
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
311
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [3] 0 0
Moash Medical Center Dept of Neurology - Clayton
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Alfred Hospital Research - Melbourne - Prahan, Melbourne
Recruitment hospital [6] 0 0
Concord Hospital Neuroscience Department - New South Wales
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
3184 - Prahan, Melbourne
Recruitment postcode(s) [6] 0 0
- New South Wales
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
United States of America
State/province [16] 0 0
West Virginia
Country [17] 0 0
Austria
State/province [17] 0 0
Graz
Country [18] 0 0
Austria
State/province [18] 0 0
Linz
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Hradec-Kralove
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Olomouc
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Ostrava
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Pardubice
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Prague
Country [24] 0 0
Israel
State/province [24] 0 0
Ashkelon
Country [25] 0 0
Israel
State/province [25] 0 0
Beer Sheva
Country [26] 0 0
Israel
State/province [26] 0 0
Haifa
Country [27] 0 0
Israel
State/province [27] 0 0
Holon
Country [28] 0 0
Israel
State/province [28] 0 0
Jerusalem
Country [29] 0 0
Israel
State/province [29] 0 0
Nahariya
Country [30] 0 0
Israel
State/province [30] 0 0
Petach Tikva
Country [31] 0 0
Israel
State/province [31] 0 0
Tel Aviv
Country [32] 0 0
Israel
State/province [32] 0 0
Tel Hashomer
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
Poland
State/province [35] 0 0
Gdansk
Country [36] 0 0
Poland
State/province [36] 0 0
Katowice
Country [37] 0 0
Poland
State/province [37] 0 0
Lublin
Country [38] 0 0
Poland
State/province [38] 0 0
Poznan
Country [39] 0 0
Poland
State/province [39] 0 0
Warsaw
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Ekaterinburg
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Jaroslavl
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Kazan
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Moscow
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Novosibirsk
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Petrozawodsk
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Rostov-on Don
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Samara
Country [48] 0 0
Russian Federation
State/province [48] 0 0
St Petersburg
Country [49] 0 0
Russian Federation
State/province [49] 0 0
St. Petersburg
Country [50] 0 0
Slovakia
State/province [50] 0 0
Bratislava
Country [51] 0 0
Slovakia
State/province [51] 0 0
Levoca
Country [52] 0 0
Slovakia
State/province [52] 0 0
Martin
Country [53] 0 0
Slovakia
State/province [53] 0 0
Nitra
Country [54] 0 0
Slovakia
State/province [54] 0 0
Nova Ves
Country [55] 0 0
Slovakia
State/province [55] 0 0
Prestov
Country [56] 0 0
Slovakia
State/province [56] 0 0
Trnava
Country [57] 0 0
South Africa
State/province [57] 0 0
Worcester
Country [58] 0 0
Switzerland
State/province [58] 0 0
Lausanne
Country [59] 0 0
Switzerland
State/province [59] 0 0
Zurich

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/study/NCT00300196
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/study/NCT00300196