EUCTR2011-001716-59-NO进行中（未招募）1 期
A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness of an Intravenous Infusion of AZD2927 in Patients Undergoing an Invasive Electrophysiological Procedure
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •*Male or postmenopausal female, aged 20 to 80 years inclusive
- •*Clinical indication for catheter ablation of atrial flutter
- •*History of paroxysmal atrial flutter, with or without paroxysmal AF. *Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study.
- •*Sinus rhythm at randomisation
- •*Adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •*Cardioversion within (=)14 days before randomisation
- •*History of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures.
- •*QTcF >450 ms or <350 ms measured in sinus rhythm at randomisation
- •*History and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia =50 beats per minute (bpm) at randomisation
- •*Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (>30 s) monomorphic ventricular tachycardia
研究者
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