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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-000514-35
    Sponsor's Protocol Code Number:Protect-U
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-29
    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 ConcernedFinland - Fimea
    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)
    Aivovaltimoaneurysmien vuodon ehkäisy lääkehoidon ja yksilöllistetyn lääketieteen keinoin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to reduce the growth of a localized enlargement of a blood vessel inside the head by managing risk factors
    Aivovaltimoaneurysman lääkehoito
    A.3.2Name or abbreviated title of the trial where available
    PROTECT-U & Protect-Finns
    AAn lääkehoito
    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 SponsorTampere University Hospital
    B.1.3.4CountryFinland
    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 supportTampere University Hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTampere University Hospital
    B.5.2Functional name of contact pointTAYS Neurokirurgian klinikka
    B.5.3 Address:
    B.5.3.1Street AddressElämänaukio, Kuntokatu 2
    B.5.3.2Town/ cityTampere
    B.5.3.3Post code33520
    B.5.3.4CountryFinland
    B.5.4Telephone number+35844472 8407
    B.5.6E-mailjuhana.frosen@pshp.fi
    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 magensaftresistente Tabletten
    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.3.10.3Concentration 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
    Unruptured intracranial aneurysm
    Vuotamattomat aivovaltimoaneurysmat
    E.1.1.1Medical condition in easily understood language
    A localised enlargement of a blood vessel in the brain
    Toistaiseksi puhkeamaton aivovaltimon paikallinen pullistuma.
    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 21.1
    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 daily measurements using a home blood pressure measuring device reduces the risk of aneurysm rupture or growth compared with standard care (i.e. no ASA, blood pressure management according to guidelines which usually advise treatment if systolic blood pressure exceeds 140mmHg, and no home device for daily blood pressure measurements). (Protect-U study)
    Tämän tutkimukseen ensisijainen tavoite on selvittää voiko vuotamattoman aivovaltimoaneurysman kasvua hidastaa tai hillitä 100mg/päivä aspiriinilääkityksellä ja tehokkaalla verenpaineen hoidolla (tavoite verenpaine alle 120mmHg). Potilaita seurataan päivittäisillä verenpainemittauksilla, ja mikäli heidän verenpaineensa nousee yli tavoite tason, hoidetaan verenpainetta nykyisten hoitosuositusten mukaisesti. (Protect-U tutkimus)


    E.2.2Secondary objectives of the trial
    The secondary aim is to identify biomarkers that discriminate patients at risk of aneurysm formation, growth, or rupture and that are responsive to growth preventing pharmaceutical treatment with aspirin. (Protect-Finns study)


    Tutkimuksen toissijainen tavoite on löytää biomarkkereita, joiden avulla voi tunnistaa ne potilaat jotka ovat aivovaltimoaneurysman muodostumisen, kasvun, tai vuodon riskissä, ja joihin voisi aspiriini lääkehoidolla vaikuttaa. (Protect-Finns tutkimus)


    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protect Finns, version 1.2, December 4th 2019
    objective: to study biomarkers that discriminate patients at risk of aneurysm growth, formation, or rupture and that are responsive to growth preventing phharmaceutical treatment with aspirin.
    Protect Finns tutkimus, versio 1.2, 4.joulukuuta 2019
    Tavoite: Tutkia biomarkkereita joiden avulla voi tunnistaa aivovaltimopullistuman kasvun, muodostumisen, tai puhkeamisen riskissä olevia potilaita, sekä sen että kuka aivovaltimoaneurysmapotilaista saa hyvän hoitovasteen aneurysman kasvua ehkäisevästä aspiriini lääkehoidosta.
    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 (in-house) aneurysm imaging with either CTA/MRA within the last 3 months
    • Ability of subject to understand character and individual consequences of clinical a interventional trial
    • Not legally incapacitated
    • Written informed consent (must be available before enrolment in the trial)
    • For women with childbearing potential adequate contraception
    * Potilaalla vähintään yksi vuotamaton kovankalvonsisäinen sakkulaarinen aneurysma, johon ei suunnitellla kirurgista tai suonensisäistä hoitoa, ja jota aneurysmaa seurataan säännöllisin kuvauksin kasvun varalta
    * Ikä 18 vuottaa tai enemmän
    * Viimeisin aivovaltimoaneurysman kuvaus CT-angiografialla tai MR-angiografialla viimeisen 3 kk:den sisällä
    * Kyky ymmärtää potilastiedot sekä tutkimuksen luonne ja mahdolliset vaikutukset potilaalle
    * Oikeustoimikelpoinen
    * Potilastiedotteeseen tutustumisen jälkeen allekirjoitettu potilassuostumus
    * Fertiili-ikäisten naisten kohdalla riittävän raskauden ehkäisyn käyttö
    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 interventional trial
    • Life-expectancy <3 years
    * Muu kuin sakkulaarinen aivovaltimoaneurysma tai AV-malformaatioon liittyvä aneurysma
    * Päivittäinen aspiriinin käyttö muuhun indikaatioon
    * Varfariini lääkityksen tai DOAC antikoagulaatiolääkityksen käyttö
    * Tunnettu yliherkkyys aspiriinille tai muulle sukulaislääkkeelle tai tutkimusvalmisteen ainesosalle
    * Tunnetut aspiriinilääkityksen vasta-aiheet kuten hyytymishäiriöt, vatsa- tai suolistohaavaumat, akuutti maksan tai munuaisten vajaatoiminta, vaikea sydämen vajaatoiminta, metotreksaattilääkitys 15mg/viikko tai suuremmalla annoksella
    * Samanaikainen muun antitromboottilääkkeen käyttö, joka yhdistettynä aspiriiniin aiheuttaisi merkittävän vuotoriskin tai komplikaation riskin
    * Stage IV tai V krooninen munuaisten vajaatoiminta (GFR <30ml/min/1.73m2)
    * Raskaus tai imetys
    * Osallistuminen muuhun kliiniseen tutkimukseen
    * Elinaikaodote alle 3 vuotta
    E.5 End points
    E.5.1Primary end point(s)
    Aneurysm growth (increase in any aneurysm diameter by ≥1mm) or rupture (i.e. aneurysmal subarachnoid hemorrhage, SAH)
    Aivovaltimoaneurysman kasvu (läpimitan suureneminen yli 1mm) tai vuoto (lukinkalvonalainen verenvuoto)
    E.5.1.1Timepoint(s) of evaluation of this end point
    36±6 months under intervention
    36±6 kuukautta
    E.5.2Secondary end point(s)
    • 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)
    • Development of de novo aneurysm on serial imaging
    • Clipping/coiling during the study period
    • Any ischemic or haemorrhagic stroke, defined as clinical symptoms of stroke AND a compatible lesion on imaging (either plain head CT / CT perfusion / MRI)Myocardial infarction defined as increase of Troponin, CKMB and/or presence of new significant Q waves obtained in ECG
    • Quality of life
    • Vascular death (including fatal stroke, fatal myocardial infarction, sudden death)
    • Death from all other causes
    • 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 achieved
    • Blood pressure; any data on blood pressure management used
    • Safety aspects (adverse and serious adverse events, including those mentioned above)
    * Aivovaltimoaneurysman tilavuuden kasvu yli 10% tai yli 3mm3 tai selkeä muutos aneurysman muodossa
    * Uuden aneurysman muodostuminen
    * Aneurysman kirurginen tai suonensisäinen hoito tutkimuksen aikana
    * Iskeeminen tai hemorrhaginen aivoverenkiertohäiriö
    * Sydäninfarkti
    * Elämänlaatu
    * Kuolema verenkiertohäiriön johdosta
    * Kuolema muista syistä
    * Merkittävä, sairaalahoitoa vaativa verenvuoto
    * Verenpainemittaukset
    * Mahdolliset lääkityksen haittavaikutukset
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months under intervention
    36 kuukautta
    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
    Tavanomainen vuotamattoman aivovaltimoaneurysman hoito
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Viimeisen potilaan viimeinen tutkimuskäynti (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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state200
    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
    Ei minkäänlaisia.
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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