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    Summary
    EudraCT Number:2018-002195-40
    Sponsor's Protocol Code Number:CHOICE
    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:2018-07-17
    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 number2018-002195-40
    A.3Full title of the trial
    CHemical OptImization of Cerebral Embolectomy
    in patients with acute stroke treated with mechanical thrombectomy
    Optimización química de la embolectomía cerebral en pacientes con un ictus agudo tratados con trombectomía mecánica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mejoría química del tratamiento que recanaliza (“destapa”) las arterias cerebrales en pacientes con ictus agudo tratados con diferentes dispositivos que permiten la extracción mecánica del trombo cerebral
    Mejoría química del tratamiento que recanaliza (“destapa”) las arterias cerebrales en pacientes con ictus agudo tratados con diferentes dispositivos que permiten la extracción mecánica del trombo cerebral
    A.4.1Sponsor's protocol code numberCHOICE
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    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 supportMARATO TV 3
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationANAGRAM-ESIC. S.L.
    B.5.2Functional name of contact pointClinical Trial information
    B.5.3 Address:
    B.5.3.1Street Addresscalle Provenza, 156 -4º 1ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34934515250
    B.5.5Fax number34934516631
    B.5.6E-mails.casellas@anagram-esic.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 Yes
    D.2.1.1.1Trade name Actilyse
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameActilyne
    D.3.4Pharmaceutical form Solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALTEPLASE
    D.3.9.1CAS number 105857-23-6
    D.3.9.2Current sponsor codeCHOICE
    D.3.9.3Other descriptive nameAgentes trombolíticos, código ATC: B01AD02
    D.3.9.4EV Substance CodeSUB05378MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboSolvent for solution for infusion
    D.8.4Route of administration of the placeboIntraarterial use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cerebral Embolectomy in patients with acute stroke
    embolectomía cerebral en pacientes con un ictus agudo
    E.1.1.1Medical condition in easily understood language
    Mejoría química del tratamiento que destapa las arterias cerebrales en pacientes con ictus agudo tratados con diferentes dispositivos que permiten la extracción mecánica del trombo cerebral
    Mejoría química del tratamiento que destapa las arterias cerebrales en pacientes con ictus agudo tratados con diferentes dispositivos que permiten la extracción mecánica del trombo cerebral
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    The study objective is to evaluate whether rt-PA is safe and efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and complete or near-complete recanalization of a proximal vessel occlusion but partial brain reperfusion on cerebral angiogram >50% and <91% brain reperfusion on cerebral angiography (corresponding to mTICI score 2b)
    El objetivo del estudio es evaluar si el rt-PA es seguro y eficaz como complemento a la trombectomía mecánica en pacientes con ictus isquémico agudo y recanalización completa o casi completa de una oclusión del vaso proximal pero reperfusión cerebral parcial en el angiograma cerebral >50% y <91% de reperfusión cerebral en la angiografía cerebral (correspondiente a la puntuación mTICI 2b).
    E.2.2Secondary objectives of the trial
    • The shift analysis of the modified Rankin Scale (mRS), at day 90. The mRS at 90 days will be analyzed using a proportional odds model (POM) that combine into single worst rank the last two categories (5: severe incapacity and 6: death).
    • Infarct Expansion Ratio on DWI-MRI (continuous variable), at 24h of stroke
    • Proportion of patients with excellent outcome (mRS 0-1) at day 90
    • Proportion of patients with/without infarct expansion (dichotomous variable)
    • Infarction Volume on DWI-MRI, at 24h of stroke onset
    “Shift análisis” de la escala modificada de Rankin (mRS), a los 90 días. El mRS a los 90 días se analizará utilizando un modelo proporcional de probabilidades (“POM”) que combina en el peor rango las dos últimas categorías (5: incapacidad severa y 6: muerte).
    •Relación de la extensión del infarto en la “DWI-MRI” (variable continúa), a las 24h del ictus
    •Proporción de pacientes con resultado excelente (mRS 0-1) a los 90 días.
    •Proporción de pacientes con/sin extensión del infarto (variable dicotómica)
    •Volumen del infarto en la “DWI-MRI”, a las 24h del inicio del ictus
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with symptomatic large vessel occlusion (LVO) in the anterior, middle or posterior cerebral arteries treated with MT resulting in a mTICI score 2b at end of the procedure
    2. Estimated delay to onset of rescue intraarterial rt-PA or placebo administration <24 hours from symptom onset, defined as the point in time the patient was last seen well
    3. No significant pre-stroke functional disability (modified Rankin scale 0-1)
    4. Age ≥18
    5. ASPECTS >6 on non-contrast CT (NCCT) scan if symptoms lasting <4.5 hours or ASPECTS > 6 on CT-Perfusion (CTP) if symptoms >4.5 <24 hours. In both cases, ASPECTS is obtained within <75 minutes of the onset of mechanical thrombectomy
    6. Informed consent obtained from patient or acceptable patient surrogate
    1. Pacientes con oclusión sintomática de gran vaso (OGV) en la arteria cerebral anterior, media o posterior tratada con TM, que da como resultado una puntuación mTICI 2b al final del procedimiento
    2. Tiempo estimado hasta el inicio de la administración de rt-PA intraarterial de rescate o placebo <24 horas desde el inicio de los síntomas, definido como el momento en que el paciente fue visto bien por última vez
    3. Sin discapacidad funcional significativa previa al ictus (escala de Rankin modificada 0-1)
    4. Edad ≥18
    5. ASPECTS >6 en TC sin contraste (TCSC) si el tiempo desde el inicio de los síntomas es <4.5 horas o ASPECTS >6 en TC-Perfusión (TCP) si el tiempo desde el inicio de los síntomas es >4.5 y <24 horas. En ambos casos, el ASPECTS se obtiene dentro de los 75 minutos previos al inicio de la trombectomía mecánica
    6. Consentimiento informado firmado por el paciente o un representante del mismo
    E.4Principal exclusion criteria
    1. NIHSS score on admission >25
    2. Contraindication to IV t‐PA as per local national guidelines (except time to therapy)
    3. Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy
    4. Female who is pregnant or lactating or has a positive pregnancy test at time of admission
    5. Current participation in another investigation drug or device treatment study (except observational study i.e.: RACECAT)
    6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
    7. Known coagulopathy, INR >1.7 or use of novel anticoagulants <12h from symptom onset
    8. Platelets <50,000
    9. Renal Failure as defined by a serum creatinine >3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] <30
    10. Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
    11. Any hemorrhage on CT/MRI
    12. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
    13. Suspicion of aortic dissection
    14. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
    15. History of life threatening allergy (more than rash) to contrast medium
    16. SBP >185 mmHg or DBP >110 mmHg refractory to treatment
    17. Serious, advanced, terminal illness with anticipated life expectancy <6 months
    18. Pre-existing neurological or psychiatric disease that would confound evaluation
    19. Presumed vasculitis or septic embolization
    20. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas)
    1. NIHSS al ingreso >25
    2. Contraindicación para el t-PA IV según las guías de práctica locales/nacionales (excepto el tiempo hasta terapia)
    3. Uso de stents en la arteria carótida durante el procedimiento endovascular que requiera doble terapia antiplaquetaria
    4. Mujer embarazada, en periodo de lactancia o con una prueba de embarazo positiva en el momento del ingreso
    5. Participación en otro estudio terapéutico con un fármaco o dispositivo en investigación (excepto estudio observacional, por ejemplo: RACECAT)
    6. Diátesis hemorrágica hereditaria o adquirida conocida, deficiencia de algún factor de la coagulación
    7. Coagulopatía conocida, INR >1.7 o uso de nuevos anticoagulantes <12h desde el inicio de los síntomas
    8. Plaquetas <50.000
    9. Insuficiencia renal definida por una creatinina sérica > 3.0 mg/dl (o 265,2 μmol/l) o tasa de filtración glomerular [TFG] <30
    10. Sujeto que requiere hemodiálisis o diálisis peritoneal, o que tiene una contraindicación para un angiograma, sea cual sea el motivo
    11. Cualquier hemorragia en TC/RM
    12. La presentación clínica sugiere una hemorragia subaracnoidea, incluso si la TC o la RM son normales
    13. Sospecha de disección aórtica
    14. El sujeto actualmente toma drogas ilícitas o tiene un historial reciente de abuso de drogas o alcohol
    15. Antecedentes de alergia a un medio de contraste que amenazó la vida (más que una erupción)
    16. PAS >185 mmHg o PAD >110 mmHg refractaria al tratamiento
    17. Enfermedad grave, avanzada, terminal, con expectativa de vida <6 meses
    18. Enfermedad neurológica o psiquiátrica preexistente que pueda confundir la evaluación
    19. Supuesta vasculitis o embolización séptica
    20. Es poco probable que esté disponible para el seguimiento a los 90 días (por ejemplo, sin una dirección fija, visitante del extranjero)
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with an improved mTICI score ten (10) minutes after the end of study treatment will be estimated using a log-binomial regression model including the stratification variables, except centre. In the unexpected event that the model does not fit, the Poisson regression model with long-link and robust variance estimator will be used instead
    La proporción de pacientes con una mejoría en la puntuación mTICI, a los diez (10) minutos después del final del tratamiento, se estimará utilizando un modelo de regresión log-binomial que incluya las variables de estratificación, excepto el centro. En el caso inesperado de que el modelo no encaje, en su lugar se utilizará el modelo de regresión de Poisson con long-link y una estimación de varianza robusta
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 minutes after the end of the study treatment
    10 minutos tras el final del tratamiento del estudio
    E.5.2Secondary end point(s)
    • The shift analysis of the modified Rankin Scale (mRS), at day 90. The mRS at 90 days will be analyzed using a proportional odds model (POM) that combine into single worst rank the last two categories (5: severe incapacity and 6: death).
    • Infarct Expansion Ratio on DWI-MRI (continuous variable), at 24h of stroke
    • Proportion of patients with excellent outcome (mRS 0-1) at day 90
    • Proportion of patients with/without infarct expansion (dichotomous variable)
    • Infarction Volume on DWI-MRI, at 24h of stroke onset
    “Shift análisis” de la escala modificada de Rankin (mRS), a los 90 días. El mRS a los 90 días se analizará utilizando un modelo proporcional de probabilidades (“POM”) que combina en el peor rango las dos últimas categorías (5: incapacidad severa y 6: muerte).
    •Relación de la extensión del infarto en la “DWI-MRI” (variable continúa), a las 24h del ictus
    •Proporción de pacientes con resultado excelente (mRS 0-1) a los 90 días.
    •Proporción de pacientes con/sin extensión del infarto (variable dicotómica)
    •Volumen del infarto en la “DWI-MRI”, a las 24h del inicio del ictus
    E.5.2.1Timepoint(s) of evaluation of this end point
    según variable
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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 concerned6
    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
    UVUP
    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 months3
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    any
    ninguno
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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