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    Summary
    EudraCT Number:2021-001627-40
    Sponsor's Protocol Code Number:FLE-007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-10-19
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-001627-40
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm
    Un Ensayo de Fase III, Aleatorizado, Doble ciego y Controlado con placebo de una solución para inhalación de acetato de flecainida para la cardioversión de la fibrilación auricular sintomática de inicio reciente a ritmo sinusal (RESTORE-1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the efficacy of flecainide acetate inhalation solution on restoring the normal heart rhythm in patients with recent-onset, symptomatic atrial fibrillation.
    Un estudio clínico para investigar la eficacia de la solución para inhalación de acetato de flecainida para restaurar el ritmo cardíaco normal en pacientes con fibrilación auricular sintomática de aparición reciente.
    A.3.2Name or abbreviated title of the trial where available
    RESTORE-1
    RESTORE-1
    A.4.1Sponsor's protocol code numberFLE-007
    A.5.4Other Identifiers
    Name:IND NumberNumber:147305
    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 SponsorInCarda Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportInCarda Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInCarda Therapeutics, Inc.
    B.5.2Functional name of contact pointRESTORE-1 Study Lead
    B.5.3 Address:
    B.5.3.1Street Address39899 Balentine Drive, Suite 185
    B.5.3.2Town/ cityNewark
    B.5.3.3Post codeCA 94560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1510422 5522
    B.5.6E-mailRESTORE-1@incardatherapeutics.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 nameflecainide acetate
    D.3.2Product code FlecIH-103
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFlecainide Acetate
    D.3.9.1CAS number 54143-56-5
    D.3.9.2Current sponsor codeFlecainide Acetate
    D.3.9.3Other descriptive nameFLECAINIDE ACETATE
    D.3.9.4EV Substance CodeSUB13894MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recent-onset symptomatic atrial fibrillation
    Fibrilación auricular sintomática de inicio reciente
    E.1.1.1Medical condition in easily understood language
    Atrial fibrillation
    Fibrilación Auricular
    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 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of flecainide acetate inhalation solution and placebo for the conversion of atrial fibrillation (AF) to sinus rhythm (SR) in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF
    Comparar la eficacia de la solución para inhalación de acetato de flecainida y el placebo para la conversión de la fibrilación auricular (FA) a ritmo sinusal (RS) en pacientes con FA de inicio reciente, sintomática y recién diagnosticada o paroxística.
    E.2.2Secondary objectives of the trial
    To compare the effects of flecainide acetate inhalation solution and placebo on the time to conversion of AF to SR, AF-related symptoms, hospitalizations, AF-related interventions, and the time to discharge in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF
    Comparar los efectos de la solución para inhalación de acetato de flecainida y placebo en el tiempo hasta la conversión de la FA en RS, los síntomas relacionados con la FA, las hospitalizaciones, las intervenciones relacionadas con la FA y el tiempo hasta el alta en pacientes con FA sintomática de inicio reciente o paroxística.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥18 and ≤85 years of age
    2. Recent onset of symptomatic newly diagnosed or paroxysmal AF
    a) Recent onset is defined as a symptom duration ≥1 and ≤48 hours at time of dosing
    b) Newly diagnosed AF is AF that has not been diagnosed previously, independent of its duration
    c) Paroxysmal AF is defined as recurrent AF in a patient whose previous AF episode(s) self-terminated (ie, without treatment) or terminated with intervention ≤7 days of onset.
    d) A symptomatic recent-onset AF episode post cardiac ablation for paroxysmal AF would be considered eligible
    1. ≥18 y ≤85 años de edad
    2. Inicio reciente de FA sintomática recién diagnosticada o paroxística
    a. El inicio reciente se define como una duración de los síntomas ≥1 y ≤48 horas en el momento de la administración de la dosis.
    b. La FA recién diagnosticada es aquella que no se ha diagnosticado previamente, independientemente de su duración.
    c. La FA paroxística se define como FA recurrente en un paciente cuyos episodios previos de FA terminaron por sí mismos (es decir, sin tratamiento) o terminaron con una intervención ≤7 días desde el inicio.
    d. Un episodio sintomático de FA de inicio reciente posterior a la ablación cardíaca por FA paroxística se consideraría elegible.
    E.4Principal exclusion criteria
    1. History of non self-terminating AF/atrial flutter:
    a) One or more failed attempts to restore SR with pharmacological therapy
    b) ECV procedure for an AF episode ≤1 year prior to screening. Exception: One (1) prior ECV is allowed if no option for pharmacological conversion was previously available
    c) More than 3 ECV procedures in ≤5 years prior to screening
    2. Current diagnosis of persistent AF
    3. One or more episodes of AFL ≤6 months prior to randomization
    4. Hemodynamic or cardiac instability during AF:
    a) Systolic blood pressure <100 or ≥160 mmHg
    b) Diastolic blood pressure ≥95 mmHg
    c) Ventricular heart rate <80 or >160 bpm
    5. Respiratory rate >22 breaths per minute
    6. History of decompensated heart failure
    7. Evidence of significant HF defined as any of the following:
    a) Hospitalization in the last 12 months for HF or suspected HF event
    b) Most recent assessment of left ventricular ejection fraction <45%
    c) New York Heart Association Class II-IV symptoms
    d) Medication history suggestive of HF per the Investigator's discretion
    8. Signs or symptoms of ongoing myocardial ischemia, including any of the following:
    a) Significant ST segment elevation or depression (ie, ≥2 mm) on a standard 12-lead ECG
    b) Echocardiogram findings (eg, wall motion abnormalities) suggestive of acute myocardial infarction
    c) Angina pectoris, atypical angina pectoris, or receiving antianginal medication for ischemia
    9. History of MI ≤3 months of screening
    10. History of uncorrected moderate or severe aortic or mitral valvular stenosis, in the opinion of the Investigator
    11. History of LV hypertrophy with LV thickness >12 mm as observed in the most recent assessment, ie, an echocardiogram
    12. Stroke (including transient ischemic attack) ≤3 months prior to randomization
    13. History of any of the following cardiac abnormalities:
    a) Long QT syndrome
    b) Conduction system disease
    c) Brugada syndrome
    d) Torsade de pointes
    e) Diagnosed with sinus node dysfunction or any of the following:
    i. History of unexplained or cardiovascular syncope
    ii. Bradycardia suggestive of sinus node dysfunction
    iii. Prior electrical or pharmacological cardioversion associated with sinus or ventricular pause >3 seconds or ventricular heart rate <45 bpm at time of conversion
    14. Any of the following ECG-related features at screening:
    a) QT interval corrected for heart rate using the Fridericia formula (QTcF) >480 msec
    b) Wide QRS complex (ie, duration ≥120 msec) or history of documented wide QRS complex tachycardia (ie, wide QRS complex with ventricular heart rate >100 bpm)
    c) Presence of ventricular tachycardia (VT). Site telemetry should be equipped with an alarm system for VT and PVCs or be continuously visually observed prior to dosing
    15. Presence of a pacemaker
    16. Cardiac surgery for any of the exclusionary conditions (eg, valvular disease, hypertrophy, coronary artery disease) ≤6 months prior to randomization
    17. Known severe renal impairment or patient receiving dialysis
    18. Known abnormal liver function, including hepatic disease or biochemical evidence of significant liver derangement
    19. Uncorrected hypokalemia
    20. Uncorrected hypomagnesemia
    21. Chronic obstructive pulmonary disease or other established pulmonary disease in need of inhalation medication
    22. History of bronchospasm (eg, hyperreactive airways to inhalants) or difficulty inhaling medications
    23. Previous or current hospitalization for COVID-19, or any secondary cardiomyopathy from COVID-19
    24. Treatment with Class I or III AADs ≤7 days prior to randomization
    25. Treatment with amiodarone ≤12 weeks prior to randomization
    26. Known hypersensitivity to flecainide acetate or any of its active metabolites
    27. Any condition or circumstance which in the opinion of the Investigator may make the patient unsuitable for the study, such as:
    a) High risk for stroke based on the screening coagulation panel or medical history per Investigator's discretion
    b) Congenital heart disease
    c) AF that is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
    d) A serious or life-threatening medical condition
    e) An acute infection
    28. Known drug or alcohol dependence ≤12 months prior to screening as judged by the Investigator
    29. A body mass index >40 kg/m2
    30. Legally incompetent to provide informed consent
    31. Previous treatment with any other investigational drug ≤30 days from screening or 5 half-lives of the drug, whichever is longer
    32. Female of childbearing potential defined as any of the following:
    f) Not surgically sterile or postmenopausal
    g) A negative pregnancy test is unavailable at screening
    h) Pregnant or breastfeeding at screening
    Males whose sexual partners are women of childbearing potential (WOCBP) must use at least one highly effective method of contraception during the study unless permenantly sterile by bilateral orchiectomy.
    Antecedentes de FA/ALA
    1. Antecedentes de FA/ALA que no terminó por sí misma:
    a. 1 o más intentos fallidos de restaurar el RS con farmacología.
    b. Procedimiento de CVE para un episodio de FA ≤1 año. Excepción: Se permite una (1) CVE previa si no se disponía previamente de una opción para la conversión farmacológica.
    c. +3 procedimientos de CVE en ≤5 años.
    2. Diagnóstico actual de FA persistente.
    a. FA persistente definida como FA que se mantiene continuamente >7 días, incluidos los episodios finalizados por cardioversión (fármacos o cardioversión eléctrica) después de >7 días. Los pacientes con FA persistente no tienen episodios de FA que finalizan por sí mismos.
    b. Pacientes con ablación por FA persistente no son elegibles.
    3. Uno o más episodios de ALA ≤6 meses
    a. Excepción: paciente con ablación por AFL ≤3 meses sin recurrencia de ALA.
    Constantes vitales
    4. Inestabilidad hemodinámica o cardíaca durante la FA:
    a. PAS <100 o ≥160 mmHg
    b. PAD ≥95 mmHg
    c. Frecuencia cardíaca ventricular <80 o >160 lpm
    5. Frecuencia respiratoria >22 rpm
    Enfermedad cardíaca estructural relevante
    6. Antecedentes de IC.
    7. Evidencia de IC significativa:
    a. Hospitalización en los últimos 12 meses por IC o sospecha de IC.
    b. Evaluación más reciente de FEVI <45 %. En EE. UU., se requiere ECG estándar de ≤180 días. Si no, realizar ECG estándar o ECG con dispositivo portátil para confirmar la elegibilidad.
    8. Signos o síntomas de isquemia de miocardio en curso, incluido cualquiera de los siguientes:
    a. Elevación o depresión significativa del segmento ST en un ECG estándar de 12 derivaciones.
    b. Hallazgos en el ECG que sugieren IM.
    c. Angina de pecho, angina de pecho atípica o recibir medicación antianginosa para la isquemia.
    9. Antecedentes de IM ≤3 meses de la selección
    10. Antecedentes de estenosis valvular mitral o aórtica moderada o grave no corregida.
    a. Si ECG en la selección, la valvulopatía moderada o grave observada durante la exploración se considera excluyente.
    11. Antecedentes de hipertrofia del VI con grosor del VI >12 mm según lo observado en la evaluación más reciente, es decir, un ecocardiograma
    Otras afecciones CV
    12. Accidente cerebrovascular ≤3 meses.
    13. Antecedentes de:
    a. Síndrome de QT largo
    b. Enfermedad del sistema de conducción
    c. Síndrome de Brugada
    d. Torsade de pointes
    e. Diagnóstico de disfunción del nódulo sinusal o cualquiera de los siguientes:
    i. Antecedentes de síncope cardiovascular o inexplicable.
    ii. Bradicardia que sugiere disfunción del nódulo sinusal.
    iii. Cardioversión eléctrica o farmacológica previa asociada a pausa sinusal o ventricular >3 segundos o FV <45 lpm.
    14. Cualquiera de las siguientes características relacionadas con el ECG:
    a. Intervalo QT corregido para la FC mediante la fórmula de Fridericia (QTcF) >480 ms.
    b. Complejo QRS ancho o antecedentes de taquicardia por complejo QRS ancho documentada.
    c. Presencia de TV.
    15. Presencia de un marcapasos.
    16. Cirugía cardíaca por cualquiera de las afecciones excluyentes ≤6 meses.
    Afecciones no CV previas y concomitantes.
    17. Insuficiencia renal grave o diálisis.
    18. Función hepática anómala conocida.
    19. Hipocalemia no corregida (si el potasio sérico está por debajo del rango normal en la selección, se requiere una corrección terapéutica)
    20. Hipomagnesemia no corregida (si el resultado de magnesio sérico está por debajo del rango normal en la selección, se requiere una corrección terapéutica)
    21. EPOC u otra enfermedad pulmonar establecida que necesite medicación inhalada.
    a. Excepción: Pacientes con asma leve intermitente que no presentan síntomas activos en la selección y cuyo asma está bien controlada con la administración de un broncodilatador según sea necesario ≤2 días/semana, y que no han experimentado ≥2 exacerbaciones que requieran corticosteroides sistémicos orales ≤1 año
    22. Antecedentes de broncoespasmo o dificultad para inhalar medicamentos
    23. Hospitalización anterior o actual por COVID-19, o cardiomiopatía por COVID-19
    Mdtos y procedim. previos y concomitantes
    24. Tto. con AAD de clase I o III ≤7 días
    25. Tto. con amiodarona ≤12 semanas
    26. Hipersensibilidad conocida al acetato de flecainida o sus metabolitos activos
    Otro
    27. Cualquier afección o circunstancia que, en opinión del Investigador, haga al paciente no apto:
    a. Alto riesgo de accidente cerebrovascular según el panel de coagulación de la selección o los antecedentes médicos.
    b. Cardiopatía congénita
    c. FA secundaria a un desequilibrio electrolítico, enfermedad tiroidea u otra causa reversible o no cardiovascular
    d. Afección médica grave o potencialmente mortal.
    e. Infección aguda.
    28. Dependencia drogas/alcohol en ≤ 12 meses.
    29. IMC >40 kg/m2
    30. Incompetencia legal para dar consentimiento informado.
    31. Tto. previo con cualquier otro fármaco en investigación ≤ 30 días o 5 semividas del fármaco, el período más largo.
    32. Mujer en edad fértil.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients whose AF converted to SR ≤90 minutes after initiation of dosing
    La proporción de pacientes cuya FA se convirtió en RS ≤90 minutos después del inico de la administración de la dosis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ≤90 minutes after initiation of dosing
    ≤90 minutos después del inico de la administración de la dosis.
    E.5.2Secondary end point(s)
    1) The time to conversion of AF to SR ≤90 minutes after initiation of dosing
    2) The proportion of patients with AF-related symptoms at the 90 minute time point
    3) The proportion of patients requiring hospitalization prior to discharge
    4) The proportion of patients requiring additional AF-related intervention prior to discharge
    5) The time to discharge-eligible status
    • El tiempo hasta la conversión de la FA en RS ≤90 minutos después del inicio de la administración de la dosis.
    • La proporción de pacientes con síntomas relacionados con la FA a los
    90 minutos.
    • La proporción de pacientes que requieren hospitalización antes del alta.
    • La proporción de pacientes que requieren una intervención adicional relacionada con la FA antes del alta.
    • El tiempo hasta el estado de aptitud para el alta.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) ≤90 minutes after initiation of dosing
    2) 90 minutes after initiation of dosing
    3) prior to discharge
    4) discharge-eligible status
    1) ≤ 90 minutos después del inicio de la dosificación
    2) 90 minutos después del inicio de la dosificación
    3) antes del alta
    4) estado de elegibilidad para el alta
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Canada
    United States
    Hungary
    Netherlands
    Poland
    Spain
    Czechia
    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
    A patient will have fulfilled the requirements for study completion if/when the patient has completed the 96-hour follow-up contact.
    Un paciente habrá cumplido con los requisitos para completar el estudio si / cuando el paciente haya completado el contacto de seguimiento de 96 horas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 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 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 Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 400
    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)
    The Investigator may offer an alternative and/or additional treatment >90 minutes after initiation of dosing, within the institutional standard of care. The choice of the treatment is guided by patient-specific factors and patient preferences and is left to the discretion of the treating physician and to patient’s approval, with the exception of sotalol, procainamide or ibutilide, which are not allowed through the 96 hour follow-up contact.
    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 WCN
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation CYTE
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-17
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