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    Summary
    EudraCT Number:2018-004464-57
    Sponsor's Protocol Code Number:SWIFT-DIRECT
    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:2019-03-05
    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 number2018-004464-57
    A.3Full title of the trial
    Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke
    Direkte Entfernung von Blutgerinnseln im Gehirn (mechanische Thrombektomie) beim ischämischen Schlaganfall
    A.3.2Name or abbreviated title of the trial where available
    SWIFT DIRECT
    A.4.1Sponsor's protocol code numberSWIFT-DIRECT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03192332
    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 SponsorUniverstiy Hospital Bern
    B.1.3.4CountrySwitzerland
    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 supportMedtronic
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Bern
    B.5.2Functional name of contact pointNeuroclinical Trial Unit
    B.5.3 Address:
    B.5.3.1Street AddressFreiburgstrasse
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3010
    B.5.3.4CountrySwitzerland
    B.5.6E-mailnctu@insel.ch
    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 International Non-Proprietary Name (INN): Alteplase
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Limited
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALTEPLASE
    D.3.9.1CAS number 105857-23-6
    D.3.9.4EV Substance CodeSUB05378MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number580.000
    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 Yes
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    Acute Anterior Circulation Stroke
    E.1.1.1Medical condition in easily understood language
    Acute Anterior Circulation Stroke
    akuter ischämischer Hirnschlag
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective of this RCT is to measure the effect of direct mechanical thrombectomy (MT) compared with bridging thrombectomy (combined IV t-PA and MT). The primary objective is to determine whether subjects experiencing an acute ischemic stroke due to large intracranial vessel occlusion in the anterior circulation who are referred to a stroke centre with endovascular facilities and who are candidates for IV t-PA will have non-inferior functional outcome at 90 days when treated with direct MT compared to subjects treated with combined IV t-PA and MT.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to study mortality, dependency, time to reperfusion and quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent as documented by signature
    - Age ≥ 18 years
    - Clinical signs consistent with an acute ischaemic stroke
    - Neurological deficit with a NIHSS of ≥ 5 and < 30 (deficits judged to be clearly disabling at presentation)
    - Patient is eligible for IV t-PA
    - Patient is eligible for endovascular treatment/therapy
    - Randomization no later than 4 hours 15 minutes after stroke symptom onset and initiation of IV t-PA must be started within 4 hours 30 minutes of stroke symptoms onset (onset time is measured from the time when the subject was last seen well)
    - Occlusion (mTICI 0-1) of the intracranial internal carotid artery, the M1 segment of the middle cerebral artery, or both confirmed by CT or MR angiography, accessible for MT
    - Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) greater than or equal to 4 (≥ 4) based on baseline CT or MR imaging (MRI) (a region has to have diffusion abnormality in 20% or more of its volume to be considered MR-ASPECTS positive)
    E.4Principal exclusion criteria
    • Acute intracranial haemorrhage
    • Any contraindication for IV t-PA
    • Pre-treatment with IV t-PA
    • In-hospital stroke
    • Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential.
    • Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys
    • Known current participation in a clinical trial
    • Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) < 30 mL/min and /or known history of renal insufficiency or requirement for haemodialysis or peritoneal dialysis
    • Severe comorbid condition with life expectancy less than 90 days at baseline
    • Known advanced dementia or significant pre-stroke disability (mRS score of ≥ 2)
    • Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
    • Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
    • Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
    • Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT
    • Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma)
    • Radiological confirmed evidence of cerebral vasculitis
    • CTA or MRA evidence of carotid dissection
    • Evidence of additional distal intracranial vessel occlusion in another territory (i.e. A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI or CTA/MRA
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is assessed at 90 ± 15 days after randomization by a treatment-blinded certified person during the clinical visit or by a structured telephone interview by a trained person at the trial site (according to local clinical routine).
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 ± 15 days after randomization
    E.5.2Secondary end point(s)
    - All-cause mortality at 90 days: Mortality will be assessed by the mRS during the clinical visit (7-10 days or discharge or 90 day ± 15 days) or by a structured telephone interview (90 ± 15 days) according to local clinical routine. If patients/relatives do not respond the general practitioner or treating physician will be contacted.
    - Degree of disability or dependence at 90 days as assessed by the mRS (shift analysis): Disability and dependency are assessed using the mRS during the clinical visit (7-10 days or discharge and 90 ± 15 days) or during the structured telephone interview (90 ± 15 days) according to local clinical routine. If patients/relatives do not respond the general practitioner or treating physician will be contacted.
    - Change in NIHSS at 24 ± 6 hours post randomization: NIHSS will be assessed at day 0, at 24 ± 6 hours post-randomization, at day 7-10 or discharge and at 90 ± 15 days after randomization during the clinical visit by an independent trained neurologist.
    Time from arrival at emergency department to reperfusion (mTICI ≥ 2b): Time points will be assessed at day 0 from arrival at hospital until end of intervention. Additional important treatment time points will be recorded optionally by using the Bernese Stroke clock. mTICI is defined as:37
    Grad 0 = No perfusion
    Grade 1 = Antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion
    Grade 2 = Antegrade reperfusion of less than half of the occluded target artery previously ischemic territory (eg, in 1 major division of the MCA and its territory)
    Grade 3 = Antegrade reperfusion of more than half of the previously occluded target artery ischemic territory (eg, in 2 major divisions of the MCA and their territories
    - Quality of life as assessed by the EuroQol 5D-3L at 90 days: Quality of life will be assessed at 90 ± 15 days after randomization using the validated
    EuroQol 5D-3L questionnaire during the clinical visit or during a structured telephone interview by trained personnel and according to local clinical routine.
    - Successful reperfusion defined as mTICI ≥ 2b prior to endovascular treatment/device use: Reperfusion prior to endovascular treatment/device use will be assessed before the intervention at day 0 by trained neuroradiologist using the mTICI scale.
    - Successful reperfusion defined as mTICI ≥ 2b or mTICI = 3 following device use: Reperfusion following device use will be assessed during the intervention at day 0 by trained neuroradiologist using the mTICI scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 ± 15 days after randomization
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    The trial is open with the exception of the assessor of the primary endpoints, who is blinded
    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
    Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Canada
    Austria
    Finland
    France
    Germany
    Spain
    Switzerland
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 102
    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
    Patients must have a life threatening acute ischaemic stroke, which needs emergency treatment (randomisation within 4 hours 15 minutes after stroke symptom onset). Because of their disease, these patients are incapable to give informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 404
    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)
    Participants will be treated according to normal treatment routine, by judgement of the treating physician.
    Participants with ongoing adverse events at trial termination will be further followed up until recovery or until stabilization after termination for another 30 days.
    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 Decision2019-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-11
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