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    Summary
    EudraCT Number:2017-000514-35
    Sponsor's Protocol Code Number:Protect-U
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-04-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-000514-35
    A.3Full title of the trial
    Prospective Randomised Open-label Trial to Evaluate risk faCTor management in patients with Unruptured intracranial aneurysms (PROTECT-U)
    Prospectieve, gerandomiseerde, open-label trial ter beoordeling van de behandeling van risicofactoren bij patiënten met een ongeruptureerd intracranieel aneurysma (PROTECT-U)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to reduce the risk of growth or rupture of a localized dilatation of a blood vessel inside the head by managing risk factors
    Studie om het risico te verminderen op groei of barsten van een lokale bloedvat verwijding in het hoofd door de behandeling van risicofactoren
    A.3.2Name or abbreviated title of the trial where available
    PROTECT-U
    A.4.1Sponsor's protocol code numberProtect-U
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03063541
    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 SponsorRuprecht-Karls-University Heidelberg, Medical Faculty Mannheim
    B.1.3.4CountryGermany
    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 supportDr. Rolf M. Schwiete Foundation
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMM
    B.5.2Functional name of contact pointDepartment of Neurosurgery
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Kutzer-Ufer 1-3
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68167
    B.5.3.4CountryGermany
    B.5.6E-mailnima.etminan@umm.de
    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 ASS-RATIOPHARM PROTECT 100mg
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm, Germany
    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 nameASS-RATIOPHARM PROTECT 100mg
    D.3.4Pharmaceutical form Gastro-resistant 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 number100
    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
    Saccular cerebral aneurysm
    Sacculair intracranieel aneurysma
    E.1.1.1Medical condition in easily understood language
    A localized dilatation of a blood vessel in the brain
    Een lokale verwijding van een bloedvat in het hoofd
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10022758
    E.1.2Term Intracranial aneurysm
    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 aim of this study is to assess the hypothesis that a strategy with acetylsalicylic acid 100mg/day and intensive blood pressure treatment (targeted systolic blood pressure below 120mmHg) with weekly measurements using a home blood pressure measuring device reduces the risk of aneurysm rupture or growth compared with standard care (i.e. no acetylsalicylic acid, blood pressure management according to guidelines which usually advise treatment if systolic blood pressure exceeds 140mmHg, and no home device for weekly blood pressure measurements).
    Het belangrijkste doel van dit onderzoek is om de hypothese te bestuderen dat een behandelingsstrategie bestaande uit aspirine 100 mg/dag en intensieve bloeddrukverlaging (doel systolische bloeddruk <120 mm Hg) met het advies aan patiënten om wekelijks thuis hun bloeddruk te meten met een thuis-bloeddrukmeter, het risico verkleint op groei of barsten van het aneurysma vergeleken met patiënten die de standaardbehandeling krijgen (geen aspirine, bloeddrukbehandeling volgens de nu geldende richtlijn waarbij een systolische bloeddruk <140 mm Hg wordt aangehouden, en geen bloeddrukmeter thuis voor wekelijkse bloeddrukmeting).
    E.2.2Secondary objectives of the trial
    A) To assess whether acetylsalicylic acid reduces the risk of aneurysm growth or rupture compared with no acetylsalicylic acid treatment.
    B) To assess whether intensive blood pressure lowering therapy reduces the risk of aneurysm growth or rupture compared with no intensive blood pressure lowering therapy.
    C) To assess whether acetylsalicylic acid plus intensive blood pressure treatment reduces the incidence of cardiovascular events compared with standard blood pressure treatment alone.
    D) To assess whether beneficial effects of the intervention with acetylsalicylic acid and intensive blood pressure treatment are not negated by side effects of the intervention.
    E) To assess the effect of the intervention on quality of life.
    F) To investigate if the intervention is cost-effective.
    A) Te onderzoeken of acetylsalicylzuur het risico op aneurysma groei of ruptuur vermindert vergeleken met geen acetylsalicylzuur.
    B) Te onderzoeken of intensieve bloeddrukverlagende behandeling het risico vermindert op aneurysma groei of ruptuur vergeleken met geen intensieve bloeddrukverlagende behandeling
    C) Te onderzoeken of acetylsalicylzuur plus intensieve bloeddrukverlagende behandeling het risico vermindert op cardiovasculaire gebeurtenissen vergeleken met alleen standaard bloeddruk behandeling.
    D) Te onderzoeken of gunstige effecten van de interventie met acetylsalicylzuur plus intensieve bloeddrukverlagende behandeling niet teniet worden gedaan door bijwerkingen van de interventie.
    E) Te onderzoeken wat het effect van de interventie is op kwaliteit van leven.
    F) Te onderzoeken of de interventie kosten-effectief is.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient with at least one intradural, saccular unruptured aneurysm in whom it is decided not to intervene with preventive neurosurgical or endovascular aneurysm repair and who are monitored on a regular basis for aneurysm growth
    • 18 years or older
    • Last aneurysm imaging with either CTA/MRA within the last 3 months
    • Ability of subject to understand character and individual consequences of clinical trial
    • Not legally incapacitated
    • Written informed consent (must be available before enrolment in the trial)
    • For women with childbearing potential adequate contraception
    - Patiënt met tenminste een intraduraal, sacculair ongeruptureerd aneurysma bij wie besloten is om niet te intervenieren d.m.v. preventieve neurochirurgische of endovasculaire aneurysmabehandeling en die op regelmatige basis gemonitord worden voor aneurysmagroei
    - 18 jaar of ouder
    - Laatste aneurysma imaging d.m.v. CTA of MRA in de afgelopen 3 maanden
    - Begrijpt de aard en de individuele consequenties van de trial
    - Niet wilsonbekwaam
    - Geschreven informed consent (moet beschikbaar zijn voor inclusie in de trial)
    - Voor vrouwen in de vruchtbare leeftijd: adequate anticonceptie
    E.4Principal exclusion criteria
    • All non-saccular UIAs or aneurysms related to arteriovenous malformations
    • Daily ASA already prescribed for another indication
    • Use of a vitamin K antagonist or direct oral anticoagulant (DOAC) at baseline
    • History of hypersensitivity to ASA or to any other drug with similar chemical structure or to any excipient present in the pharmaceutical form of ASA
    • Other contra-indications for ASA not yet mentioned, in the dosage of 100 mg/day (e.g. bleeding disorders, gastric ulcers and/or intestinal ulcers, acute liver failure of kidney failure, severe heart failure, treatment with methotrexate in a dosage 15 mg/week or above)
    • Use of another platelet aggregation inhibitor, which in combination with ASA would give an unacceptable risk of side effects/complications
    • Chronic kidney disease stage IV and V (GFR < 30 mL/min/1.73 m2)
    • Pregnancy and lactation
    • Participation in any other clinical trial
    • Life-expectancy <3 years
    - Alle niet sacculaire aneurysmata, of aneurysmata gerelateerd aan een arterioveneuze malformatie
    - Dagelijks acetylsalicylzuur dat reeds voor een andere indicatie wordt voorgeschreven
    - Gebruik van een vitamine K antagonist of direct werkende orale anticoagulantia (DOAC) bij baseline
    - Voorgeschiedenis van overgevoeligheid voor acetylsalicylzuur of een ander medicijn met een gelijkende chemische structuur of voor een hulpstof die aanwezig is in de farmaceutische vorm van acetylsalicylzuur
    - Andere contra-indicaties voor acetylsalicylzuur die nog niet genoemd zijn, in een dosering van 100 mg/dag (bv. stollingsziekten, maagzweren en/of darmzweren, acuut leverfalen of nierfalen, ernstig hartfalen, behandeling met methotrexaat in een dosering van 15 mg/week of meer)
    - Gebruik van een andere plaatjesaggregatieremmer, die in combinatie met acetylsalicylzuur een onacceptabel risico geeft op bijwerkingen/complicaties
    - Chronische nierziekte stadium IV en V (GFR <30 mL/min/1.73 m2)
    - Zwangerschap en borstvoeding
    - Deelname aan een andere klinische trial
    - Levensverwachting <3 jaar
    E.5 End points
    E.5.1Primary end point(s)
    Aneurysm rupture (i.e. aneurysmal subarachnoid hemorrhage, SAH) or growth (increase in any aneurysm diameter by ≥1mm)
    Aneurysma ruptuur (een aneurysmatische subarachnoidale bloeding, SAB) of groei (toename in elke aneurysmadiameter met ≥ 1mm)
    E.5.1.1Timepoint(s) of evaluation of this end point
    36±6 months under intervention
    36±6 maanden behandeling
    E.5.2Secondary end point(s)
    1. Difference of aneurysm volume (defined as increase of aneurysm volume in computerized measurements from source images by >10% and >3mm3) or aneurysm shape (e.g. development of daughter sac)
    2. Development of de novo aneurysm on serial imaging
    3. Clipping/coiling during the study period
    4. Any ischemic or hemorrhagic stroke, defined as clinical symptoms of stroke AND a compatible lesion on imaging
    5. Myocardial infarction defined as increase of Troponin, CKMB and/or presence of new significant Q waves obtained in ECG
    6. Vascular death (including fatal stroke, fatal myocardial infarction, sudden death)
    7. Death from all other causes
    8. Major spontaneous bleeding requiring hospitalisation defined as substantially disabling bleeding, intraocular bleeding leading to the loss of vision, or bleeding necessitating the transfusion of at least 2 units of erythrocyte concentrates
    9. Blood pressure; any data on blood pressure management used
    10. Safety aspects (adverse and serious adverse events)
    11. Quality of life
    1. Verandering van aneurysma volume (gedefinieerd als een toename van het aneurysma volume op gecomputeriseerde metingen van bronbeelden met >10% en >3mm3) of aneurysma vorm (bv. door de ontwikkeling van een uitstulping op het aneurysma)
    2. Ontwikkeling van een nieuw aneurysma op seriële beeldvorming
    3. Clipping/coiling tijdens de studie periode
    4. Herseninfarct of hersenbloeding, gedefinieerd als klinische symptomen van een beroerte EN een compatibele laesie op beeldvorming
    5. Myocardinfarct gedefinieerd als een toename van troponine, CKMB en/of de aanwezigheid van nieuwe en significante Q golven op ECG
    6. Vasculaire sterfte (inclusief een fatale beroerte, fataal myocardinfarct, plotselinge dood)
    7. Sterfte door alle andere oorzaken
    8. Grote spontane bloeding waarvoor opname vereist is, gedefinieerd als een behoorlijke invaliderende bloeding, intra-oculaire bloeding leidend tot visusverlies, of een bloeding waar een transfusie van tenminste 2 eenheden erythrocyten concentraat voor nodig is
    9. Bloeddruk; alle data over behandeling van bloeddruk
    10. Veiligheidsaspecten (ongewenste en ernstige ongewenste voorvallen)
    11. Kwaliteit van leven
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months under intervention
    36 maanden
    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
    Standaard behandeling
    standard of care
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 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 state388
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 776
    F.4.2.2In the whole clinical trial 776
    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
    Keine
    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 UMC Utrecht
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Pharmacy of the Heidelberg University Hospital
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation University of Mannheim / Heidelberg
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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