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    Summary
    EudraCT Number:2022-003315-28
    Sponsor's Protocol Code Number:DR220153
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-11-24
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-003315-28
    A.3Full title of the trial
    Evaluating oral peri-operative acetylsalicylic acid in subjects undergoing endovascular coiling-only of unruptured brain aneurysms
    Évaluation de l’acide acétylsalicylique périopératoire par voie orale chez les patients subissant une embolisation endovasculaire d’anévrismes intracrâniens non rompus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating oral peri-operative acetylsalicylic acid in subjects undergoing endovascular coiling-only of unruptured brain aneurysms
    Évaluation de l’acide acétylsalicylique périopératoire par voie orale chez les patients subissant une embolisation endovasculaire d’anévrismes intracrâniens non rompus
    A.3.2Name or abbreviated title of the trial where available
    EVOLVE
    EVOLVE
    A.4.1Sponsor's protocol code numberDR220153
    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 SponsorUniversity of Calgary
    B.1.3.4CountryCanada
    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 supportUniversity of Calgary
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Tours
    B.5.2Functional name of contact pointClinical Trials coordinator
    B.5.3 Address:
    B.5.3.1Street Address2, boulevard Tonnellé
    B.5.3.2Town/ cityTours
    B.5.3.3Post code37044
    B.5.3.4CountryFrance
    B.5.6E-mailcpcq@chu-tours.fr
    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 SALOSPIR
    D.2.1.1.2Name of the Marketing Authorisation holderUNI-PHARMA KLEON TSETIS PHARMACEUTICALS LABORATORIES S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 nameacetylsalicylic acid
    D.3.4Pharmaceutical form Capsule
    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 69-72-7
    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 number325
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects undergoing elective endovascular coiling-only (primary or balloon-assisted) repair of unruptured brain aneurysms.
    E.1.1.1Medical condition in easily understood language
    Brain aneurysms.
    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 LLT
    E.1.2Classification code 10002334
    E.1.2Term Aneurysm cerebral (unruptured)
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Incidence of embolic strokes (clinically or on DWI-MRI) in ASA vs placebo on Day 5 of the study (12-48 hours following coiling procedure).
    E.2.2Secondary objectives of the trial
    1. Clinical thromboembolic events by Day 90 following coiling.
    2. Count of new DWI lesions on post-coiling MRI.
    3. Frequency of large (> 10 cc volume) strokes on DWI MR.
    4. Incidence of cognitive decline from baseline to 90-day follow-up.
    5. Incidence of visible thrombus formation during the coiling procedure.
    6. Total volume of embolic strokes on DWI MR imaging
    7. Death rate within 90 days following coiling in the ASA vs. placebo group.
    8. Any peri-operative hemorrhagic complication (intracranial hemorrhage, retroperitoneal hematoma, upper or lower gastrointestinal bleeding, or any bleeding stratified as major according to TIMI (Thrombolysis in Myocardial Infarction) trial in the ASA vs. placebo group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years on the day of enrolment.
    2. Unruptured intracranial aneurysm suitable for coiling-only (primary coiling or balloon-assisted) as a primary treatment.
    3. Functionally independent at baseline (modified Rankin scale <3).
    4. Informed consent and availability of the subject for the entire study period.
    E.4Principal exclusion criteria
    1. Planned complex aneurysm treatment including use of any device that requires post-operative antiplatelet therapy (stent-assisted coiling or flow-diverter device), or endovascular vessel sacrifice.
    2. Planned treatment for dissecting or mycotic brain aneurysm.
    3. Any ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within 2 weeks before randomization.
    4. Allergy or contraindication to ASA .
    5. Unable to take the study drug orally for any reason.
    6. Subjects already taking single or dual antiplatelet, warfarin, or any of the non-Vitamin K antagonist oral anticoagulants.
    7. Subjects unable to undergo MRI imaging for any reason (e.g., severe claustrophobia or presence of metals).
    8. Any other medical condition that the site investigator deems would put the subject at excessive risk by participation in the study (e.g. active bleeding, symptomatic peptic ulcer disease, liver or kidney failure, thrombocytopenia or coagulopathy) or an expected life expectancy less than one year, or that would result in an inability to collect radiological outcomes and clinical outcomes at 90 days.
    9. Pregnancy or breastfeeding.
    10. Prior enrollment in EVOLVE trial for another aneurysm.
    11. Participation in another clinical trial of an investigational drug, device or procedure if the subject received the trial drug, device or procedure in the preceding 30 days from the anticipated coiling date.
    12. Subjects who are under legal protection measure (curatelle/tutelle).
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of embolic strokes (clinically or on DWI-MRI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 12-48 hours following coiling procedure
    E.5.2Secondary end point(s)
    1. Clinical thromboembolic events by Day 90 following coiling.
    2. Count of new DWI lesions on post-coiling MRI.
    3. Frequency of large (> 10 cc volume) strokes on DWI MR.
    4. Incidence of cognitive decline from baseline to 90-day follow-up.
    5. Incidence of visible thrombus formation during the coiling procedure.
    6. Total volume of embolic strokes on DWI MR imaging
    7. Death rate within 90 days following coiling in the ASA vs. placebo group.
    8. Any peri-operative hemorrhagic complication (intracranial hemorrhage, retroperitoneal hematoma, upper or lower gastrointestinal bleeding, or any bleeding stratified as major according to TIMI (Thrombolysis in Myocardial Infarction) trial in the ASA vs. placebo group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 90 days following coiling procedure
    2. 12-48 hours following coiling procedure
    3. 12-48 hours following coiling procedure
    4. 90 days following coiling procedure
    5. During the coiling procedure
    6. 12-48 hours following coiling procedure
    7. 90 days following coiling procedure
    8. 90 days following coiling procedure
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned8
    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 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 years
    E.8.9.1In the Member State concerned months36
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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 Decision2023-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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