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Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00061022
Registration number
NCT00061022
Ethics application status
Date submitted
20/05/2003
Date registered
21/05/2003
Date last updated
15/11/2010
Titles & IDs
Public title
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
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Scientific title
SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke
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Secondary ID [1]
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0
007
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Secondary ID [2]
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0
SA-NXY-0007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cerebral Stroke
0
0
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Stroke, Acute
0
0
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Cerebrovascular Stroke
0
0
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Ischemic Attack, Transient
0
0
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Condition category
Condition code
Stroke
0
0
0
0
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Haemorrhagic
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Stroke
0
0
0
0
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Ischaemic
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Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
0
0
0
0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Global disability on modified Rankin scale at 90 days.
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Assessment method [1]
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0
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Timepoint [1]
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Secondary outcome [1]
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NIH stroke scale
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Assessment method [1]
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0
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Timepoint [1]
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0
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Secondary outcome [2]
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Barthel Index
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Assessment method [2]
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0
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Timepoint [2]
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Secondary outcome [3]
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Stroke Impact Scale
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Assessment method [3]
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0
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Timepoint [3]
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0
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Secondary outcome [4]
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EQ-5D all at 90 days
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Assessment method [4]
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0
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Timepoint [4]
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0
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Secondary outcome [5]
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Safety outcomes
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Assessment method [5]
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0
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Timepoint [5]
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0
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Eligibility
Key inclusion criteria
* Males and females
* Acute ischemic stroke with limb weakness
* Onset of symptoms within 6 hours
* Full functional independence prior to the present stroke
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Unconsciousness
* Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
* Severe illness with life expectancy less than 6 months.
* Known severe kidney disorder.
* Current known alcohol or illicit drug abuse or dependence.
* Pregnant or breast-feeding.
* Treatment with acetazolamide and methotrexate is not permitted during the infusion
* Participation in a previous clinical study within 30 days.
* Meets all other exclusion criteria.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Final
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Recruitment in Australia
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Research Site - Bedford Park
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Research Site - New Lambton
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Recruitment hospital [7]
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Research Site - Parkville
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- Bedford Park
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- Box Hill
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- Camperdown
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- Gosford
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- Heidelberg
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Recruitment postcode(s) [6]
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- New Lambton
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Recruitment postcode(s) [7]
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- Parkville
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Funding & Sponsors
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Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
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Summary
Brief summary
This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.
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Trial website
https://clinicaltrials.gov/study/NCT00061022
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Trial related presentations / publications
Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71. doi: 10.1056/NEJMoa070240.
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Public notes
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Contacts
Principal investigator
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AstraZeneca NXY-059 Medical Science Director, MD
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AstraZeneca
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Results not provided in
https://clinicaltrials.gov/study/NCT00061022
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