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VASST: Safety and Efficacy Study in Acute Ischaemic Stroke

Sponsor
Vernalis (R&D) Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT00144014
Collaborator
(none)
49
Enrollment
28
Locations
5
Arms
43
Duration (Months)
1.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.
Study Start Date :
Aug 1, 2005
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: V10153, 1.0 mg/kg

Single acute intravenous bolus dose

Drug: V10153
Single acute intravenous bolus dose up to 10 mg/kg
Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa

    		•
    Experimental: V10153, 2.5 mg/kg

    Single acute intravenous bolus dose

    Drug: V10153
    Single acute intravenous bolus dose up to 10 mg/kg
    Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa

    		•
    Experimental: V10153, 5.0 mg/kg

    Single acute intravenous bolus dose

    Drug: V10153
    Single acute intravenous bolus dose up to 10 mg/kg
    Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa

    		•
    Experimental: V10153, 7.5 mg/kg

    Single acute intravenous bolus dose

    Drug: V10153
    Single acute intravenous bolus dose up to 10 mg/kg
    Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa

    		•
    Experimental: V10153, 10 mg/kg

    Single acute intravenous bolus dose

    Drug: V10153
    Single acute intravenous bolus dose up to 10 mg/kg
    Other Names:
  • Code Names: V10153, BB-10153
  • CAS Registry Number: 931101-84-7
  • Proposed INN: Troplasminogen alfa

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. To compare recanalisation rates across dose levels. [Ongoing]

    2. To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index. [Post-study completion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Summary of Inclusion Criteria:

    1. Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment

    2. Aged 18 and above

    3. Provide consent

    4. 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.

    5. NIHSS score greater than 5 or less than or equal to 20.

    Summary of Exclusion Criteria:

    1. Coma

    2. Stroke with unknown time of onset

    3. Minor stroke symptoms and sings (<6 points on the NIHSS) which are rapidly improving by the time of randomisation.

    4. Major stroke symptoms and signs (>20 on the NIHSS)

    5. History of stroke in previous 6 weeks

    6. History of brain tumours

    7. CT scan results in an ASPECT score of <5

    8. Haemorrhagic risk

    9. Abnormal laboratory values

    10. Positive urine pregnancy test, lactation or parturition within previous 30 days.

    11. Weight >135 kg

    12. Uncontrolled hypertension.

    13. Raised blood glucose

    14. History of or current serious illness

    15. Participation in another clinical trial within 4 weeks of drug administration

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stroke Centre, Mayo Clinic Scottsdale Arizona United States 85054
    2 UCLA Stroke Network Los Angeles California United States 90024
    3 Neurology Medical Group of Diablo Valley Walnut Creek California United States 94598
    4 Bethesda Memorial Hospital Boynton Beach Florida United States 33435
    5 Bradenton Research Centre Bradenton Florida United States 34205
    6 Ocala Neurodiagnostic Centre Ocala Florida United States 34470
    7 Florida Hospital of Neuroscience Institute Orlando Florida United States 32804
    8 Tallahassee Memorial Hospital Tallahassee Florida United States 32308
    9 Florida Neurovascular Institue Stroke Center Tampa Florida United States 33606
    10 Vascular Neurology, Loyola University Medical Center Maywood Illinois United States 60153
    11 Center for Advanced Medicine, Jewish Hospital Louisville Kentucky United States 40202
    12 University of Louisville Hospital Louisville Kentucky United States 40202
    13 UMAS Memorial Medical Centre Worcester Massachusetts United States 01655
    14 Sunrise Hospital and Medical Centre Las Vegas Nevada United States 89109
    15 Washoe Stroke Center Reno Nevada United States 89502
    16 Stroke Centre, Neurological Institute, Carolinas Medical Centre Charlotte North Carolina United States 28203
    17 Forsyth Medical Center Winston Salem North Carolina United States 27103
    18 Lancaster General Hospital Lancaster Pennsylvania United States 17602
    19 University of Pennsylvania Medical Center Philadelphia Pennsylvania United States 19104
    20 Medical University South Carolina Hospitals and Clinics Charleston South Carolina United States 29425
    21 Erlanger Health System Chattanooga Tennessee United States 37404
    22 Neurological Institute, The Methodist Hospital Houston Texas United States 77030
    23 Division of Neuro-Ophthalmology, Virginia Commonwealth University Richmond Virginia United States 23298-0599
    24 Gordon & Leslie Diamond Health Care Centre Vancouver British Columbia Canada V5Z 1M9
    25 Centre for Stroke Research, Vancouver Island Health Research Centre Victoria British Columbia Canada V8R 1J8
    26 71 King Street West Mississauga Ontario Canada L5B 4A2
    27 Royal University Hospital Saskatoon Saskatchewan Canada S7K 0L4
    28 Hospital Charles LeMoyne Quebec Canada J4V 2H1

    Sponsors and Collaborators

    • Vernalis (R&D) Ltd

    Investigators

    • Principal Investigator: Michael Hill, Foothills Hosptial

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vernalis (R&D) Ltd
    ClinicalTrials.gov Identifier:
    NCT00144014
    Other Study ID Numbers:
    • V10153-2S-01
    First Posted:
    Sep 2, 2005
    Last Update Posted:
    Jun 3, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Vernalis (R&D) Ltd
    Acute
    Ischaemic
    Stroke
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke

    Study Results

    No Results Posted as of Jun 3, 2016