Dronedarone

Ensayo de Sanofi en Atrial Fibrillation (del registro, en inglés).

Fase: Fase 4
Estado: Interrumpido
Participantes: 292
Centros: 43
Fin del objetivo primario: dic 2011

Título oficial en el registro (en inglés): Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA)

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en nov 2009.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «'Sponsor decision following recruitment issues, not related to any safety concerns in the study».

Qué mide

Proportion of participants with at least one symptomatic, ECG confirmed, AF recurrence (6 months from initial cardioversion) (del registro, en inglés)

Qué se prueba

Se compara si tomar dronedarone a diario desde cinco a siete días antes de la cardioversión evita mejor las recurrencias de fibrilación auricular que empezarlo solo después, en adultos con fibrilación auricular persistente.

Lo que dice el documentodaily administration of dronedarone started 5-7 days before cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in adult patients with persistent AF, for whom cardioversion is clinically indicated and planned to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of cardiovascular hospitalization due to AF.

Traducción automática (claude-haiku-5-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To determine whether daily administration of dronedarone started 5-7 days before cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in adult patients with persistent AF, for whom cardioversion is clinically indicated and planned to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of cardiovascular hospitalization due to AF. Secondary Objectives: Main Secondary : * To assess the number of symptomatic AF recurrences/patient/6 months with and without ECG confirmation; * To assess characteristics of symptomatic AF recurrence in the two treatment arms (frequency, duration of episodes, type, number, and severity of AF symptoms per patient); * To compare the rates of early recurrences of AF between the two treatment strategies; Other secondary: * To assess whether there is a difference in proportion of patients with symptomatic AF recurrences (with and without ECG confirmation) between the two treatment strategies; * To assess whether there is a difference in number of electrical cardioversions per patient between the two treatment strategies; * To assess the impact of the two strategies on number of shocks, cumulative amount of energy delivered, shock failure, and immediate success of cardioversion; * To assess whether there is a difference in rate of cardiovascular (CV) hospitalizations and length of hospital stay between the two treatment strategies; * To assess whether there is a difference in quality of life between the two treatment strategies.

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Ficha completa en ClinicalTrials.gov (NCT01026090), actualizada en ago 2014.