ENSURE-AFA Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation
Edoxaban
+ Warfarin
+ Enoxaparin
Fibrilación Auricular+2
+ Arritmias Cardíacas
+ Enfermedades Cardiovasculares
Estudio de Tratamiento
Resumen
Fecha de inicio: 25 de marzo de 2014
Fecha en la que se inscribió al primer participante.The purpose of this study is to compare edoxaban (investigational drug) with warfarin and enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot complications in subjects with atrial fibrillation whose doctors plan to treat them with an electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required. Participants will have an equal chance of receiving either treatment. Participants will be in the study for a maximum of 82 days. Study procedures will include physical examinations, vital signs (pulse and sitting blood pressure), ECG (electrocardiogram), finger prick blood clotting tests, blood samples and urine samples. The study is expected to show that edoxaban will provide comparable incidence rates to warfarin plus enoxaparin, the current standard treatment for both efficacy and bleeding.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 2199 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Has signed informed consent * Is older than minimum legal adult age (country specific) * Has had ongoing AF lasting at least 48 hrs but \<= 12 months (with or without valvular heart disease) * Has treatment plan that includes for electrical cardioversion * Has NVAF or other specific valvular heart diseases (eg, mitral valve prolapse, mitral valve regurgitation, and aortic valve disease) Exclusion Criteria: * Has AF that is transient or reversible * Has contraindicated condition, ie, conditions considered to be formal indication for conventional anticoagulation * Has a history of left atrial appendage (LAA) closure * Has a known thrombus in LAA, the left atrial, left ventricle or aorta - or an intracardial mass * Has had myocardial infarction (MI), stroke, acute coronary syndrome (ACS), or percutaneous coronary intervention (PCI) within the past 30 days * Has any contraindication to anticoagulant agents * Has had protocol-defined signs of bleeding or conditions associated with high risk of bleeding that would preclude participation * Is receiving, or plans to receive during the study period, dual antiplatelet therapy (DAPT) or invasive procedures (other than routine endoscopy) in which bleeding would be anticipated * Has received prohibited concomitant medication or therapy * Has had protocol-defined signs of bleeding or high * Has inadequate liver, kidney, and blood test results * Received any investigational drug or device within the past 30 days or plans to during the study period * Has reproductive potential and does not agree to take proper contraceptive measures * Has active cancer requiring chemotherapy/radiation/major surgery within the next 3 months * Has significant active concurrent medical illness or infection or life expectancy less than 6 months * In the opinion of the investigator, is unlikely to comply with the protocol or complete the study, has had drug or alcohol dependence within the past year, or has any other condition that might place the participant at increased risk of harm * Is a participant in the United States after January 2015 with creatinine clearance (CrCL) greater than 95 mL/minute
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 12 ubicaciones
Second site in
Copenhagen, DenmarkBad Friedrichshall
Heilbronn, GermanyFirst site in
Budapest, Hungary