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    Summary
    EudraCT Number:2022-001287-10
    Sponsor's Protocol Code Number:NBK241/2/2022
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-08-03
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-001287-10
    A.3Full title of the trial
    Treatment of acute ischemic stroke due to occlusion of a large vessel by mechanical thrombectomy in patients with unknown onset or not meeting the criteria for CT eligibility (ASPECTS <6) based on MRI criteria (DWI-FLAIR mismatch)
    Leczenie ostrych udarów niedokrwiennych mózgu spowodowanych okluzją dużego naczynia metodą trombektomii mechanicznej u pacjentów o nieznanym czasie zachorowania albo niespełniających kryteriów kwalifikacji TK (ASPECTS < 6) na podstawie kryteriów MRI (DWI-FLAIR mismatch)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of acute ischemic stroke due to occlusion of a large vessel by mechanical thrombectomy in patients with unknown onset or not meeting the criteria for CT eligibility (ASPECTS <6) based on MRI criteria (DWI-FLAIR mismatch)
    Leczenie ostrych udarów niedokrwiennych mózgu spowodowanych okluzją dużego naczynia metodą trombektomii mechanicznej u pacjentów o nieznanym czasie zachorowania albo niespełniających kryteriów kwalifikacji TK (ASPECTS < 6) na podstawie kryteriów MRI (DWI-FLAIR mismatch)
    A.3.2Name or abbreviated title of the trial where available
    Wake-in
    Wake-in
    A.4.1Sponsor's protocol code numberNBK241/2/2022
    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 SponsorGdański Uniwersytet Medyczny
    B.1.3.4CountryPoland
    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 supportMedical Reaserch Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGdański Uniwersytet Medyczny
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressM. Skłodowskiej-Curie 3a, 80-210 Gdańsk
    B.5.3.2Town/ cityGdańsk
    B.5.3.3Post code80-210
    B.5.3.4CountryPoland
    B.5.4Telephone number58483491885
    B.5.6E-mailmonika.puchowska@gumed.edu.pl
    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 Proficar
    D.2.1.1.2Name of the Marketing Authorisation holderAdamed Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcetylsalicylic acid
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 2
    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 Proficar
    D.2.1.1.2Name of the Marketing Authorisation holderAdamed Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcetylsalicylic acid
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    acute ischemic stroke caused by occlusion of a large vessel
    ostry udar niedokrwienny mózgu spowodowany okluzją dużego naczynia
    E.1.1.1Medical condition in easily understood language
    acute ischemic stroke caused by occlusion of a large vessel
    ostry udar niedokrwienny mózgu spowodowany okluzją dużego naczynia
    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 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084836
    E.1.2Term Malignant ischemic 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 main objective of this study is to assess whether the mechanical thrombectomy added to standard treatment including acetylsalicylic acid is superior to standard treatment alone including acetylsalicylic acid, in patients with acute ischemic stroke due to large vessel occlusion and initial neurological deficit NIHSS ≥ 5, using functional outcome score with modified Rankin Scale, that includes patient mortality, after 90 days.
    Ocena, czy trombektomia mechaniczna dodana do standardowego postępowania terapeutycznego, tj. stosowania kwasu acetylosalicylowego (ASA) jest skuteczniejsza od samego standardowego stosowania ASA u pacjentów z ostrym udarem niedokrwiennym mózgu spowodowanym okluzją dużego naczynia (NIHSS większy lub równy 5), oceniane po 90 dniach oraz określenie potencjalnych zmian w śmiertelności pacjentów po wprowadzeniu trombektomii po 90 dniach.
    E.2.2Secondary objectives of the trial
    • Safety of the investigated treatment based on reporting all adverse and serious adverse events with focus on vessel perforation, embolism migration to new territory, and symptomatic bleeding complications rates.
    • The impact of the proposed treatment on the patients' quality of life.
    i) bezpieczeństwo badanego postępowania terapeutycznego (leczenia) oceniane na podstawie zgłaszania wszystkich niepożądanych i poważnych zdarzeń niepożądanych, ze szczególnym uwzględnieniem perforacji naczyń, migracji zatoru na nowe terytorium i częstości objawowych powikłań krwotocznych.
    ii) wpływ proponowanego postępowania terapeutycznego (leczenia) na jakość życia pacjentów.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Obtaining informed consent to participate in the trial prior to randomization.
    NOTE: Patients whose severe neurological deficit makes it impossible to sign the consent form may give their verbal consent to participate in the study. This consent should be additionally confirmed by the signature of an independent witness who is not a family member of the patient and does not participate in the study. Patients with aphasia and / or other speech disorders may be enrolled in the study if, in the opinion of the recruiting neurologist or neurologist in training, they are able to understand the study concept.
    2. Adult patients with acute ischemic stroke due to the occlusion of a large intracranial or extracranial vessel (angio-CT or angio-MR) in a place that allows mechanical recanalization using a stent-retriever.
    3. Current DWI-FLAIR mismatch.
    In the WAKE-IN study, a DWI-FLAIR mismatch is defined as:
    No hyperintense change in the FLAIR sequence corresponding to acute ischemia in DWI or the ratio of the volume of restriction of diffusion in the DWI sequence (hyperintensive lesion) to the corresponding hyperintense lesion volume in the FLAIR sequence 1.5 or higher.
    Note: The presence of other changes in the FLAIR sequence, such as "chronic" white matter lesions, do not exclude from participation in the study.
    4. The neurological deficit was assessed at 5-18 points on the NIHSS scale.
    5. Age> 18 years of age.
    Specific to each study arm:
    Arm A:
    1.Unknown time of onset (not more than 24 hours from when the patient was symptom-free), or the time from onset to estimated arterial puncture between 6 and 24 hours.
    2. Failure to meet the DAWN and DEFUSE-3 eligibility criteria.
    Arm B:
    1. From 0 to 5 points on the ASPECTS scale.
    2. Time from the first symptoms of acute stroke to arterial puncture not exceeding 6 hours.
    E.4Principal exclusion criteria
    Any of the following:
    • significant disability prior to the current event defined as> 1 point on the modified Rankin scale (mRS) and / or significant cognitive impairment prior to the current event (documented in the patient's medical record))
    • MRI contraindications or inability to identify contraindications
    • intracranial bleeding in neuroimaging tests (CT or MRI of the brain)
    • neuroimaging pathologies other than ischemia-related pathologies that may be responsible for acute symptoms
    • significant pathologies detected accidentally in neuroimaging (e.g. tumor, giant aneurysm, massive brain atrophy)
    • clinical suspicion of subarachnoid bleeding (even if the CT or MRI result is normal)
    • clinical suspicion of cerebral venous sinus thrombosis
    • previous or chronic disease of the central nervous system that significantly impairs the functional state and / or has a poor prognosis (brain tumors, aneurysms, arteriovenous malformations, open brain surgery with dura mater / dural incision)
    • infective endocarditis or pericarditis
    • known heart failure (if medical history available) with EF <25%; in the absence of information without the need for testing at the randomization stage
    • acute pancreatitis
    • severe renal failure (eGFR <30 ml / min / 1.73 m2)
    • suspected systemic vasculitis or primary central nervous system vasculitis
    • severe liver disease, including liver failure, cirrhosis, or portal hypertension
    • platelet count <100,000 / mm3
    • glucose concentration <5 mg / dl (2.8 mmol / l) or> 400 mg / dl (22.2 mmol / l) immediately before the intervention
    • very high blood pressure, i.e. systolic blood pressure> 185 mm Hg or diastolic blood pressure> 110 mm Hg immediately before the intervention
    • NOTE: If pharmacological intervention (e.g., bolus administration of labetalol or urapidil, or in the absence of a satisfactory continuous infusion response via an infusion pump) has produced a satisfactory response (blood pressure <185/110 mmHg) prior to randomization and / or initiation of treatment and in the opinion of the physician, adequate blood pressure control can be maintained throughout the course of treatment, the patient will be enrolled in the study.
    •pregnancy or breast-feeding
    • life expectancy <3 months
    participation in another clinical trial at the time of randomization or planned enrollment in another clinical trial within less than 30 days from randomization, provided that there is pathophysiological or formal-administrative interference in the protocols of these studies
    E.5 End points
    E.5.1Primary end point(s)
    Primary clinical efficacy endpoints:

    • mRS favorable (mRS less than or equal to 2) at 90 days.
    • Change in hyperintense area volume in the DWI and FLAIR sequences between baseline, 7 days and 90 days (where possible).

    Primary safety endpoints:

    • Symptomatic intracerebral haemorrhage (sICH) assessed with ECASS 2 criteria within 24 hours (any intracranial haemorrhage with neurological deterioration of at least 4 points on the NIHSS or any fatal haemorrhage).
    • Incidence of vessel perforation, embolism to new territory, acute dissection, significant vasospasm and hemodynamically significant acute bradyarrhythmia during or immediately after the intervention.

    • Incidence of deaths within 90 days of study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • after 90 days
    • between the baseline evaluation, after 7 and 90 days
    • within 24h
    • after 90 days
    E.5.2Secondary end point(s)
    Secondary endpoints:

    • Reduction in NIHSS ≥ 4 and ≥ 8 points separately at 24 hrs, 48 hrs, and 7 days
    • The patient's quality of life within selected domains with Beck Depression Rating Scale, the EQ-5D-5L Scale and the Barthel Scale.
    • The technical outcome of the procedure (grading the degree of recanalization) assessed with the Thrombolysis in Cerebral Ischemia (TICI) scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after the procedure, after 24 hours, 48 hours, 7 days, after 90 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    E.8.1.3Single blind Yes
    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
    proficar
    Proficar
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 132
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 132
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-08-03. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state264
    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
    nie dotyczy
    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 Decision2023-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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