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    Summary
    EudraCT Number:2015-002657-36
    Sponsor's Protocol Code Number:HMRI2012101/1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-10-01
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-002657-36
    A.3Full title of the trial
    Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation (TASTE) Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Tenecteplase versus Alteplase for Stroke Thrombolysis (TASTE) Trial
    A.3.2Name or abbreviated title of the trial where available
    TASTE
    A.4.1Sponsor's protocol code numberHMRI2012101/1
    A.5.4Other Identifiers
    Name:Australian New Zealand Clinical Trials RegistryNumber:ACTRN12613000243718
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Newcastle
    B.1.3.4CountryAustralia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Health and Medical Research Council
    B.4.2CountryAustralia
    B.4.1Name of organisation providing supportBoehringer Ingelheim
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Newcastle
    B.5.2Functional name of contact pointChristopher Levi
    B.5.3 Address:
    B.5.3.1Street AddressUniversity Drive, Callaghan
    B.5.3.2Town/ cityNew South Wales
    B.5.3.3Post codeNSW 2308
    B.5.3.4CountryAustralia
    B.5.4Telephone number61249215000
    B.5.6E-mailchristopher.levi@hnehealth.nsw.gov.au
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Actilyse (Alteplase)
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pty Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameActilyse
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlteplase
    D.3.9.3Other descriptive namerecombinant tissue plasminogen activator, rt-PA
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number522,000 to 696,000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Metalyse
    D.2.1.1.2Name of the Marketing Authorisation holderBoeringher Ingelheim Pty Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMetalyse
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTenecteplase
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Ischaemic Stroke
    E.1.1.1Medical condition in easily understood language
    Stroke or 'brain attack' caused by a clot
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to test the hypothesis that patients with acute hemispheric ischaemic stroke who have significant penumbra (area of potentially salvageable tissue surrounding the stroke) and a relatively small infarct core on perfusion CT or MRI within 4.5 hours of symptom onset will have less disability at 3 months when treated with IV Tenecteplase 0.25 mg/kg compared to IV Alteplase 0.9mg/kg.
    E.2.2Secondary objectives of the trial
    The secondary endpoints include:
    -Efficacy of Tenecteplase: Specifically restoration of blood flow (reperfusion) at 24 hours measured by CT perfusion scan, early clinical improvement (NIHSS score reduction at 24 hours), modified Rankin Scale (mRS) of 0-1 and 0-2 at 3 months, categorical shift in mRS at 3 months, and blood flow restoration and infarct growth at 24 hours.
    -Safety: Symptomatic intracerebral haemorrhage (bleeding in the brain) occurrance, death due to any cause, mRS of 5-6 at 3 months
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria:
    1. Patients presenting with acute hemispheric ischaemic stroke eligible using standard criteria to receive IV tPA within 4.5 hours of stroke onset.
    2. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
    3. Patient’s age is ≥ 18 years.

    Imaging inclusion criteria:
    1. Vessel occlusion on CT or MR angiography is NOT a requirement for inclusion into the study. However, the presence or absence of ICA occlusion on CT or MR angiography will be required to be noted for randomisation stratification.
    2. Presence of penumbra - Using CTP or perfusion MR, mismatch between the perfusion lesion measured on Delay Time > 3 seconds and the infarct core lesion measured on CTP relative cerebral blood flow (relCBF) or diffusion MR
    a) Mismatch ratio between (Delay Time) perfusion lesion and infarct core lesion of > 1.8
    b) Penumbra volume > 15 mL (Delay Time lesion volume – infarct core lesion volume)
    3. Infarct core lesion volume < 70 mL. Note minimum slice coverage required for CTP will be 80 mm to prevent underestimation of infarct core volume with this modality.
    4. Volume of severely hypoperfused tissue < 100 mL. Severely hypoperfused tissue will be defined by tissue with Delay Time > 8 seconds. Large volumes of severely hypoperfused tissue are indicative of a poor response to treatment.
    E.4Principal exclusion criteria
    1. Intracranial haemorrhage (ICH) identified on baseline CT or MRI.
    2. Rapidly improving symptoms at the discretion of the investigator.
    3. Pre-stroke mRS score of ≥ 2 (indicating previous disability).
    4. Participation in any investigational study in the previous 30 days.
    5. Any terminal illness such that patient would not be expected to survive more than one year.
    6. Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
    7. Pregnant women.
    8. Previous stroke within last three months.
    9. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
    10. Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (INR > 1.5).
    11. Current use of novel oral anticoagulants (NOACs) (i.e. dabigatran, rivaroxaban, edoxaban or apixiban).
    12. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
    13. Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) prior to study entry is permitted.
    14. Clinically significant hypoglycaemia.
    15. Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or > 110 mmHg diastolic on at least two separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of “aggressive treatment” is left to the discretion of the responsible Investigator.
    16. Hereditary or acquired haemorrhagic diathesis.
    17. Gastrointestinal or urinary bleeding within the preceding 21 days.
    18. Major surgery within the preceding 14 days which poses risk in the opinion of the investigator.
    19. Exposure to a thrombolytic agent within the previous 72 hours
    20. An extracranial or intracranial internal carotid artery occlusion or a proximal M1 middle cerebral artery occlusion which, in the judgment of the investigator, would be more appropriately treated with combined intravenous intra-arterial therapy, where the intra-arterial therapy can be accessed and delivered within a rapid time frame.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is Modified Rankin Scale (mRS) 0-1 at 3 months (no disability).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months post stroke
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    -Reperfusion at 24 hours post stroke*
    -Early clinical improvement (reduction in acute – 24 hour NIHSS score)*
    -Modified Rankin Scale (mRS) 0-1 at 3 months (adjusted for baseline age and NIHSS)
    -Modified Rankin Scale 0-2 at 3 months
    -Categorical shift in mRS at 3 months
    -Infarct growth at 24 hours
    -Recanalisation at 24 hours post stroke.
    *Note that there will be a planned interim efficacy analysis after 300 patients for the following endpoints: reperfusion at 24 hours post stroke, NIHSS improvement at 24 hours and mRS 0-1 at 3 months post stroke.

    Safety Endpoints:
    -Symptomatic intra-cerebral haemorrhage (sICH)*
    -Death due to any cause
    -Modified Rankin Scale (mRS) 5-6 at 3 months (severe disability or death).
    *Symptomatic intracerebral haemorrhage (sICH) is defined as “Intracerebral haemorrhage (parenchymal haematoma type 2 - PH2 within 36 hours of treatment) combined with neurological deterioration leading to an increase of ≥4 points on the NIHSS from baseline, or the lowest NIHSS value between baseline and 24 hours”.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Reperfusion, Early Clinical Improvement (reduction in acute-24hour NIHSS score), Infarct Growth and Recanalisation are at 24-hours post-stroke

    mRS 0-1, 0-2, 5-6 and a catagorical shift in mRS are at 3 months post-stroke
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective Randomised Open-label Blinded Endpoint (PROBE)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Germany
    New Zealand
    Spain
    Sweden
    Taiwan
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 224
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 1024
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    This will not be appropriate as the study drug would only be administered once, within 4.5 hours of stroke onset.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation University of Cambridge
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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