Safety and Efficacy Study in Acute Ischaemic Stroke
VASST
A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.
1 other identifier
interventional
49
2 countries
28
Brief Summary
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 stroke
Started Aug 2005
Typical duration for phase_2 stroke
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJune 3, 2016
May 1, 2016
3.3 years
September 1, 2005
May 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke.
Ongoing
Secondary Outcomes (2)
To compare recanalisation rates across dose levels.
Ongoing
To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.
Post-study completion
Study Arms (5)
V10153, 1.0 mg/kg
EXPERIMENTALSingle acute intravenous bolus dose
V10153, 2.5 mg/kg
EXPERIMENTALSingle acute intravenous bolus dose
V10153, 5.0 mg/kg
EXPERIMENTALSingle acute intravenous bolus dose
V10153, 7.5 mg/kg
EXPERIMENTALSingle acute intravenous bolus dose
V10153, 10 mg/kg
EXPERIMENTALSingle acute intravenous bolus dose
Interventions
Single acute intravenous bolus dose up to 10 mg/kg
Eligibility Criteria
You may qualify if:
- Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment
- Aged 18 and above
- Provide consent
- Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive.
- NIHSS score greater than 5 or less than or equal to 20.
You may not qualify if:
- Coma
- Stroke with unknown time of onset
- Minor stroke symptoms and sings (\<6 points on the NIHSS) which are rapidly improving by the time of randomisation.
- Major stroke symptoms and signs (\>20 on the NIHSS)
- History of stroke in previous 6 weeks
- History of brain tumours
- CT scan results in an ASPECT score of \<5
- Haemorrhagic risk
- Abnormal laboratory values
- Positive urine pregnancy test, lactation or parturition within previous 30 days.
- Weight \>135 kg
- Uncontrolled hypertension.
- Raised blood glucose
- History of or current serious illness
- Participation in another clinical trial within 4 weeks of drug administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Stroke Centre, Mayo Clinic
Scottsdale, Arizona, 85054, United States
UCLA Stroke Network
Los Angeles, California, 90024, United States
Neurology Medical Group of Diablo Valley
Walnut Creek, California, 94598, United States
Bethesda Memorial Hospital
Boynton Beach, Florida, 33435, United States
Bradenton Research Centre
Bradenton, Florida, 34205, United States
Ocala Neurodiagnostic Centre
Ocala, Florida, 34470, United States
Florida Hospital of Neuroscience Institute
Orlando, Florida, 32804, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
Florida Neurovascular Institue Stroke Center
Tampa, Florida, 33606, United States
Vascular Neurology, Loyola University Medical Center
Maywood, Illinois, 60153, United States
Center for Advanced Medicine, Jewish Hospital
Louisville, Kentucky, 40202, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
UMAS Memorial Medical Centre
Worcester, Massachusetts, 01655, United States
Sunrise Hospital and Medical Centre
Las Vegas, Nevada, 89109, United States
Washoe Stroke Center
Reno, Nevada, 89502, United States
Stroke Centre, Neurological Institute, Carolinas Medical Centre
Charlotte, North Carolina, 28203, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Medical University South Carolina Hospitals and Clinics
Charleston, South Carolina, 29425, United States
Erlanger Health System
Chattanooga, Tennessee, 37404, United States
Neurological Institute, The Methodist Hospital
Houston, Texas, 77030, United States
Division of Neuro-Ophthalmology, Virginia Commonwealth University
Richmond, Virginia, 23298-0599, United States
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
Centre for Stroke Research, Vancouver Island Health Research Centre
Victoria, British Columbia, V8R 1J8, Canada
71 King Street West
Mississauga, Ontario, L5B 4A2, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7K 0L4, Canada
Hospital Charles LeMoyne
Québec, J4V 2H1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Hill
Foothills Hosptial
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
August 1, 2005
Primary Completion
November 1, 2008
Study Completion
March 1, 2009
Last Updated
June 3, 2016
Record last verified: 2016-05