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    Summary
    EudraCT Number:2010-023507-95
    Sponsor's Protocol Code Number:2010B151NHS
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-023507-95
    A.3Full title of the trial
    Basilar Artery International Cooperation Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Basilar Artery International Cooperation Study
    A.3.2Name or abbreviated title of the trial where available
    BASICS TRIAL
    A.4.1Sponsor's protocol code number2010B151NHS
    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 SponsorBASICS Study Group
    B.1.3.4CountryNetherlands
    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 supportBasics Study Group
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTU Dresden
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstr. 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post codeD-01307
    B.5.3.4CountryGermany
    B.5.4Telephone number00493514583565
    D. IMP Identification
    D.IMP: 1
    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 Actilyse
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlteplase
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number10, 20, 50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Basilar artery occlusion
    E.1.1.1Medical condition in easily understood language
    Basilar artery occlusion
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063093
    E.1.2Term Basilar artery thrombosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048963
    E.1.2Term Basilar artery occlusion
    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
    • To evaluate the efficacy of IAT in addition to BMM compared to BMM alone in terms of favourable outcome at 90 days, defined as a modified Rankin score of 0-3, in patients with an acute ischemic stroke caused by basilar artery occlusion.
    • Secondary analysis will compare outcome in the following pre-defined subgroups:
    - Patients with a baseline NIHSS of <10, 10 -19, and those with a baseline NIHSS of  20.
    - Patients treated with IVT within 4.5 hours of symptom onset, and those treated beyond 4.5 hours of symptom onset within 4.5 hours of estimated time of basilar artery occlusion.
    - Patients treated with IVT and those with a contra-indication for IVT.
    E.2.2Secondary objectives of the trial
    - efficacy of IAT in patients with a contra-indication for IVT in terms of fa-vourable outcome at 90 days (mRS of 0-3, in patients with an acute ischemic stroke caused by BAO),
    - safety of a combined IV/IA compared to IV rt-PA alone. (symptomatic intra-cranial haemorrhage or intracranial haemorrhage contributing to patients’ death as determined by the study safety committee confirmed on neuroimaging within 3 days of treatment initiation (CT or MRI), or overall mortality at 90 days),
    - efficacy of IAT/ BMM compared to BMM alone in terms of a favourable outcome at day 90 (1) Excellent outcome defined as a mRS of 0-2, 2) mRS - not dichotomized and 3) EQ-5D. 4) An improved early response to treatment as deter-mined by a reduction in NIHSS by 5 points or more at 24 h. 5) A CT or MR angi-ography assessment of basilar artery patency at 24 h. 6) The volume of cerebral infarction as measured by a NCCT + CTA-SI at 24 h),
    - safety and efficacy of mechanical devices as the trial progresses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Symptoms and signs compatible with ischemia in the basilar artery territory.
    • Basilar artery occlusion confirmed by CTA or MRA.
    • Age18 or older (i.e., candidates must have had their 18th birthday).
    • If IVT is considered as part of BMM, IVT has to be initiated within 4.5 hours of estimated time of basilar artery occlusion.
    • Initiation of IA therapy should be feasible within 6 hours of estimated time of BAO.
    E.4Principal exclusion criteria
    • Pre-existing dependency with mRankin ≥3.
    • Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
    • Patients who require hemodialysis or peritoneal dialysis.
    • Other serious, advanced, or terminal illness.
    • Any other condition that the investigator feels would pose a significant hazard to the patient if IA therapy is initiated.
    • Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).
    • Informed consent is not or cannot be obtained.

    Imaging Exclusion Criteria
    • Lesion consistent with hemorrhage of any degree.
    • Significant cerebellar mass effect or acute hydrocephalus.
    • Bilateral extended brainstem ischemia.
    E.5 End points
    E.5.1Primary end point(s)
    Favourable outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 90
    E.5.2Secondary end point(s)
    Excellent outcome at day 90 defined as a modified Rankin Score (mRS – functional scale) of 0-2.
    Modified Rankin Score – not dichotomized.
    National Institutes of Health Stroke Scale (NIHSS – acute assessment scale) at time of IVT, at time of randomization, at 24 hours post treatment.
    EQ-5D (quality of life) at day 90 and at 12 months
    Radiologic outcomes
    Recanalization at 24 hours, + or - 6 hours, by CT angiography.
    Volume of cerebral infarction on NCCT and CTA source images.

    Safety outcomes
    Symptomatic intracranial hemorrhage at 24 hours CT imaging, + or -6 hours.
    Mortality at 90 days.

    Quality of life outcomes
    EuroQol EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 90
    at 24 hours CT imaging + or - 6 hours
    1year
    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 Yes
    E.6.5Efficacy Yes
    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 No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no arterial approach
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    provided in the protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Informed consent of comatous patients will be replaced by either consent of an independent physician, a legal guardian or judge
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 750
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
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