NL-OMON41862已完成2 期
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 S066913 in paRoxysmal Atrial Fibrillation -IKur inhibitor (DIAGRAF - IKUR) - DIAGRAF - IKUR
Institut de Recherches Internationales Servier I.R.I.S0 个研究点目标入组 34 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult patients (except women of childbearing potential) potentially eligible for atrial fibrillation ablation, In sinus rhythm at selection visit or within 7 days after selection visit.
- •With 1 documented episodes of AF in within 18 months before selection and at least 2 other episodes of AF within 30 days prior to selection (symptomatic or asymptomatic). 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,
- •Informed consent obtained.
- •During baseline period, AF/AT burden must be * 1% and * 70% and at least 3 episodes of AF.
排除标准
- •Main non-selection criteria
- •* AF secondary to a reversible cause,
- •* 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.
- •* women with childbearing potential
- •*Main non-inclusion criteria
- •* Unreliable ICM recording
- •* Sustained ventricular tachycardia, asystole, or sustained bradycardia according to ICM interrogation
研究者
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