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    Summary
    EudraCT Number:2022-001067-27
    Sponsor's Protocol Code Number:20604
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-001067-27
    A.3Full title of the trial
    A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA
    Ensayo fase III multicéntrico, internacional, aleatorizado, controlado con placebo, doble ciego, de grupos paralelos y determinado por eventos, del inhibidor oral del FXIa -Asundexian (BAY 2433334), para la prevención de ictus isquémicos en pacientes de ambos sexos mayores de edad, tras un ictus isquémico no cardioembólico agudo o AIT de alto riesgo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn more about asundexian (also called BAY2433334) for prevention of ischemic stroke in male and female participants aged 18 years and older who already had such a stroke due to a blood clot that formed outside the heart and travelled to the brain, or temporary stroke-like symptoms
    Ensayo para conocer más acerca de asundexian (también llamado BAY2433334) para la prevención de ictus isquémicos en pacientes de ambos sexos mayores de edad, que ya hayan tenido un ictus por un coágulo de sangre que se formó fuera del corazón y viajó hasta el cerebro, o que hayan tenidos síntomas temporales de ictus.
    A.3.2Name or abbreviated title of the trial where available
    Oral faCtor Eleven A iNhibitor asundexIan as novel anti-thrombotiC – STROKE study
    Inhibidor oral del Factor XI, asundexian, como antri-trombótico novel-Ensayo STROKE
    A.4.1Sponsor's protocol code number20604
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressMüllerstrasse 178
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayer.com
    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 No
    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 nameAsundexian
    D.3.2Product code BAY 2433334
    D.3.4Pharmaceutical form Film-coated 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 INNAsundexian
    D.3.9.1CAS number 2064121-65-7
    D.3.9.2Current sponsor codeBAY 2433334
    D.3.9.4EV Substance CodeSUB218206
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboFilm-coated tablet
    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
    Prevention of ischemic stroke in patients post acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack
    Prevención de ictus isquémico en pacientes tras un ictus isquémico no cardioembólico agudo o ataque isquémico transitorio de alto riesgo
    E.1.1.1Medical condition in easily understood language
    Prevention of ischemic stroke in people after such a stroke due to a blood clot that formed outside the heart (non-cardioembolic) and travelled to the brain, or after temporary stroke-like symptoms
    Prevención de ictus isquémico en pacientes tras un ictus debido a un coágulo que se formó fuera del corazón (no-cardioembólico) y que ha viajado al cerebro , o tras un ictus temporal
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10049165
    E.1.2Term Cerebrovascular accident prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10072760
    E.1.2Term Transient ischemic attack
    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
    Efficacy
    To evaluate whether the oral FXIa inhibitor asundexian is superior to placebo on top of background antiplatelet therapy in reducing ischemic stroke in patients after an acute non-cardioembolic ischemic stroke or high-risk Transient ischemic attack (TIA)

    Safety
    To compare the incidence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding for asundexian and placebo on top of antiplatelet therapy in patients after an acute noncardioembolic ischemic stroke or high-risk TIA
    Eficacia
    Evaluar si el inhibidor oral del FXIa asundexian es superior al placebo en la reducción de ictus isquémico en pacientes tratados con antiagregantes plaquetarios de base, tras un ictus isquémico no cardioembólico agudo o un ataque isquémico transitorio de alto riesgo (AIT)

    Seguridad
    Comparar la incidencia de hemorragia mayor según la Sociedad Internacional de Trombosis y Hemostasia (ISTH) entre asundexian y placebo cuando se administra junto a antiagregantes plaquetarios de base en pacientes tras un ictus isquémico no cardioembólico agudo o un ataque isquémico transitorio de alto riesgo.
    E.2.2Secondary objectives of the trial
    Efficacy
    To evaluate whether asundexian is superior to placebo on top of antiplatelet therapy in reducing the occurrence of composite and individual efficacy endpoints

    Safety
    To compare asundexian and placebo on top of antiplatelet therapy with respect to individual bleeding endpoints

    Net clinical benefit
    To further compare the benefit and risk of asundexian and placebo with respect to a composite of efficacy and safety endpoints
    Eficacia
    Evaluar si asundexian es superior a placebo, añadido al tratamiento antiagregante plaquetario de base, en la reducción de aparición de criterios de valoración de la eficacia combinados o individuales.

    Seguridad
    Comparar asundexian con placebo ,añadido al tratamiento antiagregante plaquetario de base, respecto a los criterios de valoración individuales de sangrado.

    Beneficio clínico neto
    Seguir comparando el beneficio y riesgo de asundexian y placebo respecto a la combinación de los objetivos de eficacia y seguridad
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Magnetic resonance imaging (MRI) Sub-study: to correlate baseline MRI findings with future events (e.g. covert brain infarction, recurrent strokes, intracranial bleeding), identify asundexian responders, further characterize the study population by MRI and add additional safety information on the asundexian 50 mg dose (to the Phase 2 study).
    Sub-estudio de imágenes por resonancia magnética (MRI): para correlacionar los hallazgos iniciales de la MRI con eventos futuros (p. ej., infarto cerebral encubierto, accidentes cerebrovasculares recurrentes, hemorragia intracraneal), identificar a los respondedores de asundexian, caracterizar aún más la población del estudio mediante MRI y agregar información de seguridad adicional sobre el asundexian a dosis de 50 mg (para el estudio de Fase 2).
    E.3Principal inclusion criteria
    1. Participants must be ≥ 18 years of age
    2. Acute non-cardioembolic stroke or high-risk TIA
    3. Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
    1. Pacientes con edad igual o superior a 18 años
    2. Ictus no-cardioembólico agudo o AIT de alto riesgo.
    3. Aterosclerosis sistémica o cerebrovascular o infarto agudo no-lacunar.
    E.4Principal exclusion criteria
    1. Ischemic stroke ≤ 7 days before the index stroke event
    2. Index stroke following procedures or strokes due to other rare causes
    3. History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring anticoagulation
    1. Ictus isquémico en los 7 días anteriores al evento índice de ictus.
    2. Ictus (evento índice) después de procedimientos o ictus debidos a otras causas raras
    3. Antecedentes de fibrilación/aleteo auricular, trombo en el ventrículo izquierdo, válvula mecánica u otra fuente cardioembólica de ictus que requiera anticoagulación.
    E.5 End points
    E.5.1Primary end point(s)
    1. Time to first occurrence of ischemic stroke
    2. Time to first occurrence of ISTH major bleeding
    1. Tiempo a la primera aparición de ictus isquémico
    2. Tiempo a la primera aparición de sangrado mayor según la ISTH
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 31 months
    Hasta 31 meses
    E.5.2Secondary end point(s)
    1. Time to first occurrence of all strokes (ischemic and hemorrhagic)
    2. Time to first occurrence of composite of Cardiovascular (CV) death, myocardial infarction (MI) or stroke
    3. Time to first occurrence of composite of all-cause mortality, MI or stroke
    4. Time to first occurrence of disabling stroke (mRS ≥3 at 90 days)
    5. Time to first occurrence of all-cause mortality
    6. Time to first occurrence of transient ischemic attack (TIA)
    7. Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding
    8. Time to first occurrence of ISTH clinically relevant non-major bleeding
    9. Time to first occurrence of symptomatic intracranial hemorrhage
    10. Time to first occurrence of hemorrhagic stroke
    11. Time to first occurrence of fatal bleeding
    12. Time to first occurrence of minor bleeding
    13. Time to first occurrence of composite of ischemic stroke or ISTH major bleeding
    14. Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding
    15. Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage
    1. Tiempo a la primera aparición de todos los ictus (isquémicos y hemorrágicos)
    2. Tiempo a la primera aparición de la combinación de muerte cardiovascular (CV), infarto de miocardio (IM) o ictus
    3. Tiempo a la primera aparición de la combinación de muertes por cualquier causa, IM o ictus
    4. Tiempo a la primera aparición de ictus incapacitante (mRS>=3 en el día 90)
    5. Tiempo a la primera aparición de muertes por cualquier causa.
    6. Tiempo a la primera aparición de ataque isquémico transitorio. (AIT)
    7. Tiempo a la primera aparición de la combinación de episodios hemorrágicos mayores o hemorragias no mayores clínicamente relevantes según la ISTH (Sociedad Internacional de Trombosis y Hemostasia)
    8. Tiempo a la primera aparición de hemorragias no mayores clínicamente relevantes
    9. Tiempo a la primera aparición de hemorragias sintomáticas intracraneales.
    10. Tiempo a la primera aparición de ictus hemorrágicos
    11. Tiempo a la primera aparición de hemorragias fatales
    12. Tiempo a la primera aparición de hemorragias menores
    13. Tiempo a la primera aparición de la combinación de ictus isquémico o hemorragia mayor según ISTH
    14. Tiempo a la primera aparición de la combinación de muerte CV, todos los ictus, IM o hemorragia mayor según ISTH
    15. Tiempo a la primera aparición de la combinación de muertes por cualquier causa, ictus incapacitante, hemorragia fatal, hemorragia sintomática intracraneal
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 31 months
    Hasta 31 meses
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarcadores
    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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA289
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    China
    Colombia
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Taiwan
    United States
    Austria
    Finland
    France
    Latvia
    Lithuania
    Poland
    Sweden
    Bulgaria
    Netherlands
    Romania
    Spain
    Switzerland
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Denmark
    Hungary
    Norway
    Portugal
    Slovakia
    Turkey
    United Kingdom
    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
    The end of the study is defined as the date of the last visit of the last subject in the study globally (LVLS).
    El final del ensayo se define como la fecha de la última visita realizada por el último paciente a nivel global (LVLP)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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: 3100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6200
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects with limited capacities to give consent due to the acute ischemic stroke symptoms and initial disabilities
    Sujetos con capacidad reducida para otorgar su consentimiento debido a los síntomas del ictus isquémico agudo y las discapacidades iniciales.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state578
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 9300
    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, subjects will receive normal treatment of the condition
    Ninguno; los sujetos recibirán el tratamiento habitual de su condición
    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 Decision2022-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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