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    Summary
    EudraCT Number:2020-005451-20
    Sponsor's Protocol Code Number:MMI_2020_35
    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:2021-04-19
    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 number2020-005451-20
    A.3Full title of the trial
    REperfusion with P2Y12 inhibitors in addition to mEchanical thRombectomy for perFUsion imaging selected acute Stroke patiEnts : a multicentric randomized controlled trial
    Administration de cangrélor en complément de la thrombectomie mécanique pour la reperfusion des AVC ischémiques aigus diagnostiqués en imagerie de perfusion : essai randomisé contrôlé multicentrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    REperfusion with P2Y12 inhibitors in addition to mEchanical thRombectomy for perFUsion imaging selected acute Stroke patiEnts : a multicentric randomized controlled trial
    Administration de cangrélor en complément de la thrombectomie mécanique pour la reperfusion des AVC ischémiques aigus diagnostiqués en imagerie de perfusion : essai randomisé contrôlé multicentrique
    A.4.1Sponsor's protocol code numberMMI_2020_35
    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 SponsorFondation A. de Rothschild Hospital
    B.1.3.4CountryFrance
    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 supportFoundation A. de Rothschild Hospital
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFoundation A. de Rothschild Hospital
    B.5.2Functional name of contact pointPatrick Vachey
    B.5.3 Address:
    B.5.3.1Street Address29 rue Manin
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75019
    B.5.3.4CountryFrance
    B.5.6E-mailpvachey@for.paris
    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 KENGREXAL
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCANGRELOR
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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
    patients with a clinical diagnosis of AIS consecutive to LVO between 0 and 24 hours of symptom onset and selected by perfusion imaging
    patients présentant un diagnostic d'AIS par occlusion d'un gros vaisseau cérébral entre 0 et 24 heures après l'apparition des symptômes et pouvant bénéficier d'une MT d’après l'imagerie de perfusion
    E.1.1.1Medical condition in easily understood language
    patient being treated for a stroke caused by the occlusion of an artery in the brain and who needs a thrombectomy
    patient pris en charge pour un AVC causé par l’occlusion d’une artère du cerveau et qui doit bénéficier d’une thrombectomie
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    to evaluate the efficacy of P2Y12 inhibitor (cangrelor) in addition to MT and BMM compared to MT and BMM alone on functional outcome at 3 months, in AIS patients selected on perfusion imaging between 0 and 24h after stroke onset
    Evaluer l'efficacité de l’administration IV de l'inhibiteur P2Y12 (cangrelor) en plus de la MT et de la BMM par rapport à la MT et à la BMM seules sur le pronostic fonctionnel à 3 mois, chez des patients ayant subi un accident ischémique cérébral aigu éligible à la MT sur la base de l'imagerie de perfusion entre 0 et 24h après le début des symptômes
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of cangrelor in addition to MT and BMM compared to MT and BMM on:
    1) Functional outcome at 3 months (“shift analysis”)
    2) Reperfusion results at the end of treatment
    3) Early neurological improvement at 24 hours
    4) Stroke volume at 24-36 hours
    To evaluate the safety of cangrelor in addition to MT and BMM compared to MT and BMM on:
    5) Mortality at 3 months
    6) Complications such as symptomatic intracranial hemorrhage at 24-36 hours
    7) Or any intracranial hemorrhage at 24-36 hours
    Évaluer l'efficacité de l'inhibiteur P2Y12 (cangrelor) en plus de la MT et de la BMM par rapport à la MT et à la BMM seules sur :
    1) le pronostic fonctionnel à 3 mois.
    2) la reperfusion à la fin de l'intervention,
    3) l’amélioration neurologique clinique à 24h,
    4) le volume de l’infarctus à 24-36h,
    - Évaluer la sécurité de l'inhibiteur P2Y12 (cangrelor) en plus de la MT et de la BMM par rapport à la MT et à la BMM seules sur :
    5) la mortalité à 3 mois,
    6) la survenue d’une hémorragie intracrânienne symptomatique à 24h-36h
    7) toutes hémorragies intracrâniennes à 24h-36h
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age18 or older
    - Anterior circulation intracanial large artery occlusion (Intracranial ICA and/or MCA-M1) proved on CTA or MRA.
    - Symptoms onset < 24h at imaging
    - Indication for MT and fulfillment of the following brain imaging criteria :

    1. Perfusion imaging: An initial infarct volume (ischemic core on DWI or CTP calculated by the RAPID software) of less than 70 ml, a ratio between the critically hypoperfused lesion volume (calculated by RAPID with a TMax>6s) and initial infarct volume of 1.8 or more, and an absolute difference between those 2 volumes of 15 ml or more.

    OR (if perfusion imaging not available or uninterpretable) :

    2. CORE CLINICAL MISMATCH: Core calculated on CTP or DWI by RAPID, <25 mL if NIHSS 10-20 and <50 mL id NIHSS>20

    - NIHSS ≥ 6
    18 ans ou plus
    - Occlusion d’un gros vaisseaux de la circulation antérieure intrâcranienne (T carotidien et/ou ACM) sur CTA (Angioscanner) ou MRA (Angio IRM).
    - Heure de début des symptômes inférieure ou égale à 24 heures (au moment de la réalisation de l’imagerie médicale)
    - Indication de MT et un des deux critères d’imagerie suivants :
    1. A l’imagerie de perfusion : volume initial d'infarctus (noyau ischémique en DWI ou CTP calculé par le logiciel RAPID) inférieur à 70 ml, rapport entre le volume du tissu ischémique (calculé par RAPID avec un TMax>6s) et le volume initial de l'infarctus de 1,8 ou plus, et une différence absolue entre ces deux volumes (volume absolu d'ischémie potentiellement réversible (pénombre)) de 15ml ou plus.

    OU (si l’imagerie de perfusion n’est pas disponible ou initerprétable) :

    2. Mismatch clinico-radiologique: volume du noyau calculé en CTP ou DWI par RAPID <25ml si NIHSS entre 10 et 20 et <50ml si NIHSS >20

    - NIHSS ≥ 6
    E.4Principal exclusion criteria
    - Contraindication to MT
    - Patient over 80 years old with >10 microbleeds on pre-treatment MRI
    - Onset of symptoms unknown
    - Pre-existing dependency with mRS pre-stroke ≥3.
    - Tandem ICA-MCA occlusions requiring stenting
    - ASPECT<6 on NCCT or DWI-MRI
    - Known hypersensitivity to cangrelor or to any of the excipients (mannitol, sorbitol)
    - History of previous intracranial hemorrhage
    - Evidence of active bleeding or acute trauma (fracture) on examination
    - Recent surgery with a significant risk of bleeding
    - Oral anticoagulation with INR >1.7
    - Heparin or direct oral anticoagulants (DOACs) in previous 48 hours
    - Platelet count <100 000 mm3
    - Women of chilbearing age
    - Patient benefiting from a legal protection
    - Non-membership of a national insurance scheme
    - Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person
    - Participation in another study regarding AIS care interfering with this study
    - Contre-indication à la MT
    - Patient de plus de 80 ans avec >10 microbleeds à l’IRM pré-traitement
    - Hanficap pré-existant : mRS pré-AVC ≥3
    - Dernière fois vu normale >24 heures
    - Occlusions en tandem ICA-MCA nécessitant l’implantation d’un stent
    - ASPECT < 6 sur NCCT ou DWI-IRM
    - Antécédents d'hémorragie intracrânienne
    - Preuve de saignement actif ou de traumatisme aigu (fracture) à l'examen.
    - chirurgie récente avec un risque de re-saignement significatif
    - Hypersensibilité connue au cangrelor ou à l'un des excipients (mannitol, sorbitol)
    - Anticoagulation orale avec INR >1,7
    - Héparine ou anticoagulants oraux directs (DOAC) dans les 48 heures précédentes
    - Numération plaquettaire <100 000 mm3
    - Femme en âge de procréer
    - Patient bénéficiant d'une protection juridique
    - Non-affiliation à un régime d'assurance national
    - Opposition du patient ou (en cas d'inclusion d'urgence) de la personne de confiance
    - Participation à une autre étude concernant les soins des AIS interférant avec la présente étude
    E.5 End points
    E.5.1Primary end point(s)
    Favorable functional outcome defined by a modified Rankin Scale (mRS) score ≤ 2 at 3 months
    Le résultat principal sera le taux de patients ayant une autonomie fonctionnelle favorable définie par un score modifié de Rankin (mRS) ≤ 2 à 3 mois.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mois
    E.5.2Secondary end point(s)
    1) mRS shift analysis at 3 months
    2)
    a. Rate of near or complete reperfusion at end of treatment defined by modified treatment in cerebral infarction (mTICI) score 2c or 3.
    b. Rate of successful reperfusion at end of treatment defined by modified treatment in cerebral infarction (mTICI) score of 2b or 2c or 3.
    3) Change in NIHSS from baseline to 24 hours after treatment.
    4) Volume assessed by the ASPECTS score (Assessment in Acute Stroke Alberta Stroke Program Early CT) at 24-36 hours
    5) Rate of all-cause mortality at 3 months
    6) Rate of symptomatic intracranial hemorrhage according the ECASS III definition associated to at least 4 points worsening in NIHSS at 24-36h after treatment
    7) Rate of any intracranial hemorrhage according the ECASS III definition at 24-36h after treatment
    Score mRS à 3 mois
    2) a) Reperfusion complète définie par un score mTICI (modified treatment in cerebral infarction) de 2c ou 3 en fin de procedure.
    b) Reperfusion satisfaisante définie par un score mTICI de 2b ou 2c ou 3 en fin de procedure.
    3) Evolution du score NIHSS entre l’inclusion et 24h après l’intervention.
    4) Volume évalué par le score ASPECTS (Assessment in Acute Stroke Alberta Stroke Program Early CT) sur l’imagerie de 24-36 heures.
    5) Mortalité toutes causes à 3 mois
    6) Hémorragie intracrânienne symptomatique définie par la classification ECASS III et par une degradation d’au moins 4 points du score NIHSS à 24-36h
    7) Toute hémorragie intracranienne définie par la classification ECASS III à 24-36h
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    3 mois
    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 No
    E.6.4Safety No
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned15
    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
    dernière visite du dernier patient
    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 months51
    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: 368
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state368
    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 Decision2021-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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