EUCTR2011-002789-18-GB
进行中（未招募）
1 期
A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING PHASE II STUDY ASSESSING RANOLAZINE IN THE MAINTENANCE OF SINUS RHYTHM AFTER ELECTRICAL CARDIOVERSION IN PATIENTS WITH NON-PERMANENT ATRIAL FIBRILLATION - RAFFAELLO - Ranolazine in AF following an electrical cardioversion
Menarini Ricerche S.p.A0 个研究点目标入组 240 人2012年2月14日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- ON-PERMANENT ATRIAL FIBRILLATION
- 发起方
- Menarini Ricerche S.p.A
- 入组人数
- 240
- 状态
- 进行中（未招募）
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Male or female patients 18 years and older;
- •2\. Patients with persistent AF suitable for electrical direct current
- •cardioversion (DCC);
- •NOTE: According to the ESC classification, persistent AF is defined as a
- •continuous AF with a minimum duration of 7 days or requiring
- •termination by cardioversion. Prior to randomisation, successful
- •electrical cardioversion and maintenance of sinus rhythm at 2 hours
- •shall be documented;
- •3\. A female of childbearing potential may be enrolled providing she:
- •\- has a negative pregnancy test at baseline and
排除标准
- •1\. Patients with first diagnosed AF (namely first onset of AF irrespective
- •of duration of arrhythmia or presence and severity of AF related
- •symptoms) or patients with paroxysmal AF (namely self\-terminating AF
- •usually within 48 hours although it may continue for up to 7 days);
- •2\. Patients with long\-standing persistent AF (for this protocol defined as
- •AF longer than 6 months) or permanent AF (i.e. AF accepted by the
- •patient and by the physician);
- •3\. Patients having known concurrent temporary secondary causes of AF
- •such as alcohol intoxication, pulmonary embolism, hyperthyroidism,
- •pneumonia, hypoxemia, acute pericarditis or myocarditis;
结局指标
主要结局
未指定
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