E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-Valvular Atrial Fibrillation (AF) in patients undergoing Cardioversion |
Fibrilación auricular (FA) no valvular en pacientes sometidos a cardioversión |
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E.1.1.1 | Medical condition in easily understood language |
Heart rhythm disorder |
Ritmo cardiaco alterado |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003658 |
E.1.2 | Term | Atrial fibrillation |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The study objective is to assess the occurrence of clinical endpoints in non-valvular AF subjects (ie, without rheumatic mitral valve disease, a prosthetic mechanical heart valve, or mitral valve repair) indicated for early cardioversion and treated with apixaban or usual care (parenteral heparin and/or oral anticoagulation with Vitamin K antagonist (excluding other novel oral anticoagulants). Clinical endpoints include: occurrence of stroke, systemic embolism, major bleeding, clinically relevant non-major bleeding, and death. |
El objetivo del estudio es evaluar la aparición de los criterios de valoración clínicos en pacientes con FA no valvular (es decir, sin valvulopatía mitral reumática, prótesis valvular mecánica o valvuloplastia mitral) en los que está indicada la cardioversión precoz y tratados con apixabán o con la anticoagulación habitual (heparina parenteral o anticoagulación oral con un antagonista de la vitamina K [excluidos otros anticoagulantes orales nuevos], o ambas cosas). Los criterios de valoración clínicos son: aparición de ictus, embolismo sistémico, hemorragia grave, hemorragia no grave pero de importancia clínica y muerte. |
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E.2.2 | Secondary objectives of the trial |
Cardioversion details: timing, type, attempts, and rhythm status. Length of in-hospital stay. Use of image guidance eg, TEE/TOE or CT. |
Información sobre los detalles de la cardioversión: momento de su realización, tipo, intentos y estado del ritmo cardíaco. La duración de la estancia hospitalaria El uso de guía mediante imágenes. p.ej: ecocardiografía transesofágica [ETE] o tomografía computarizada [TC]) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Subjects with non-valvular atrial fibrillation indicated for cardioversion and initiation of anticoagulation in accordance with the approved local label. 2.Age >o=18 years. 3.Evidence of a personally signed and dated informed consent document indicating that the subject (or their legally-recognized representative) has been informed of all pertinent aspects of the study. 4.The subject is willing to provide contact details for at least one alternate person for study staff to contact regarding their whereabouts, should the subject be lost-to-follow-up over the course of the study. 5.Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active. 6.Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures. |
1. Pacientes con fibrilación auricular no valvular en los que está indicada la cardioversión e instauración de anticoagulación de acuerdo con la ficha técnica local aprobada. 2. Edad >o= 18 años. 3. Existencia de un documento de consentimiento informado, firmado y fechado personalmente, que indique que se ha informado al paciente (o a su representante legal) de todos los aspectos pertinentes del estudio. 4. El paciente está dispuesto a facilitar al personal del estudio los datos de contacto de al menos otra persona a fin de que indique el paradero del paciente en caso de que este se pierda para el seguimiento a lo largo del estudio. 5. Las mujeres en edad fértil deben comprometerse a utilizar un método anticonceptivo de gran eficacia durante todo el estudio y hasta al menos 28 días después de la última dosis del tratamiento asignado. Un paciente tiene capacidad de procrear si, en opinión del investigador, es biológicamente capaz de tener hijos y es sexualmente activo. 6. Los pacientes deben estar dispuestos y ser capaces de cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio. |
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E.4 | Principal exclusion criteria |
1.Subjects currently taking an oral anticoagulant. 2.Contraindications to apixaban or usual care (eg, VKA) in accordance with the approved local label. 3.Severe haemodynamically compromised subjects requiring emergent cardioversion. 4.Clinically significant (moderate or severe) mitral stenosis. 5.Conditions other than atrial fibrillation that require chronic anticoagulation (eg, a prosthetic mechanical heart valve). 6.Pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product. 7.Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation. 8.Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 9.Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are BMS/Pfizer employees directly involved in the conduct of the trial. |
1. Tratamiento actual con un anticoagulante oral. 2. Contraindicaciones para el apixabán o el tratamiento habitual (por ejemplo, AVK) según la ficha técnica local aprobada. 3. Compromiso hemodinámico grave que precisa cardioversión emergente. 4. Estenosis mitral clínicamente significativa (moderada o intensa). 5. Trastornos distintos de la fibrilación auricular que precisen anticoagulación crónica (por ejemplo, una prótesis valvular mecánica). 6. Mujeres embarazadas, en período de lactancia o que no quieren o no pueden usar un método anticonceptivo muy eficaz según se indica en este protocolo durante todo el estudio y hasta al menos 28 días después de la última dosis del medicamento en investigación. 7. Participación en otros estudios con fármacos en investigación (fases I a IV) en los 30 días previos al inicio del presente estudio o durante la participación en el mismo. 8. Cualquier trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier alteración analítica que aumente el riesgo asociado a la participación en el estudio o a la administración del medicamento en investigación o pueda interferir en la interpretación de los resultados del estudio y, en opinión del investigador, impida la participación del paciente. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Stroke. Systemic embolism. Major Bleeding. Clinically Relevant Non-Major Bleeding. All cause death. |
Ictus Embolismo sistémico Hemorragia grave Hemorragia no grave pero de importancia clínica Muerte por cualquier causa |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Clinical end points will be assed during the 30 days following early cardioversion or 90 days post randomization if cardioversion is not performed within that timeframe. |
Los criterios de valoración clínicos se medirán durante los 30 días siguientes a partir de la cardioversión precoz o, en el caso de que no se realice la cardioversión en ese plazo, durante 90 días a partir de la aleatorización. |
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E.5.2 | Secondary end point(s) |
-Cardioversion details: timing, type, attempts, and rhythm status. -Length of in-hospital stay. -Use of image guidance eg, TEE/TOE or CT. |
Información sobre los detalles de la cardioversión: momento de su realización, tipo, intentos y estado del ritmo cardíaco. La duración de la estancia hospitalaria. El uso de guía mediante imágenes.(p. ej., ecocardiografía transesofágica [ETE] o tomografía computarizada [TC]). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary end points will be assesed during the 30 days following early cardioversion or 90 days post randomization if cardioversion is not performed within that timeframe. |
Las variables secundarias se medirán durante los 30 días siguientes a partir de la cardioversión precoz o, en el caso de que no se realice la cardioversión en ese plazo, durante 90 días a partir de la aleatorización. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Canada |
Denmark |
Germany |
Israel |
Italy |
Japan |
Korea, Republic of |
Romania |
Spain |
Sweden |
United States |
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E.8.7 | Trial 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
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End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the study as stated in the regulatory application (ie, Clinical Trial Application (CTA)) and ethics application in the Member State. |
El final del ensayo en un Estado miembro de la UE se define como el momento en el que se considera que el número de pacientes que han sido incluidos y han finalizado el estudio es suficiente, según se indica en la solicitud presentada a las autoridades (p.ej. solicitud de ensayo clínico, CTA) y en la solicitud presentada ante el CEIC en el Estado miembro. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |