A randomized, double blind, placebo-controlled, parallel, international multicenter study assessing the efficacy of S066913 in patients with paroxysmal atrial fibrillation Double-blind, International study AssessinG efficacy of S 066913 in paRoxysmal Atrial Fibrillation – IKur inhibitor (DIAGRAF - IKUR) - DIAGRAF-IKur

Institut de Recherches Internationales Servier0 个研究点目标入组 160 人开始时间: 2014年8月26日最近更新: 2015年10月12日

研究概览

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•- Adult patients ( except women of childbearing potential) with clinical indication for atrial fibrillation ablation,
•- In sinus rhythm at selection visit
•- With at least one AF episode recorded by ECG , Holter, ICM or any other method to record ECG tracing within 90 days prior to selection visit, and with at least two other symptomatic AF episodes in the medical history within 30 days prior to selection visit, OR, with at least two AF episodes recorded by ECG, Holter, ICM or any other method to record ECG tracing
•within the last 12 months prior to selection visit at 2 different dates, and with at least two other symptomatic AF episodes in the medical history within 30 days prior to selection visit
•- Eligible for and agreeing to receive ICM implantation following local guidelines and practice, or patients already implanted with an ICM device of the same type as used in the study
•- According to the report extracted from ICM interrogation performed locally by the investigator, AF/AT burden = 1% and = 50% and at least 3 episodes of AF in 4 weeks before inclusion
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 104
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•- AF secondary to a reversible cause,
•- Any history of persistent or permanent AF,
•- Patient with more than one anti-arrhythmic drug stopped due to lack of efficacy (rather than intolerance or side effect), provided they were administered at recommended anti-arrhythmic dose,
•- Patients previously treated with amiodarone that was stopped because of lack of efficacy, or amiodarone treatment within 3 months prior to selection,
•- Corrected QT interval duration (Fridericia?s formula) > 450 ms for male, 470 ms for female,
•- High degree atrio-ventricular block (2nd degree or complete),
•- Any history of sustained ventricular tachycardia, or resuscitated sudden death,
•- Severe chronic heart failure,
•- Recent acute coronary syndrome or revascularization
•- Unreliable ICM recording
•- Sustained ventricular tachycardia, asystole, or sustained bradycardia according to ICM interrogation

发起方