EUCTR2005-000204-13-DK进行中（未招募）不适用
A double-blind, randomised, placebo-controlled, parallel-group, multicentre, phase II study to assess the efficacy of AZD7009 (AR-H065522XX) given intravenously (infusion for 15 or 30 minutes) to patients for conversion of atrial fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •1.Provision of informed consent.
- •2.Clinical indication for cardioversion of AF.
- •3.Current episode of AF lasting between 48 h and 90 days, before day of
- •randomisation.
- •4.Patients with no prior cardioversion or patients with 1 or 2 successful cardioversion(s) of AF/Atrial Flutter(AFl) during the last 12 months. Each successful cardioversion must be followed by at least 3 months in SR.
- •5.Effective oral anticoagulation according to local routines or a TEE without any
- •finding of intracardial thrombus or signs of thrombogenecity.
- •6.Age from 18 up to 80 years.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior unsuccessful cardioversion of AF/AFl.
- •2.Women of childbearing potential (only postmenopausal or surgically sterilised
- •women may be included).
- •3.Ongoing atrial flutter.
- •4.Myocardial infarction, unstable angina pectoris or other signs of myocardial
- •ischaemia or cardiac surgery/percutaneous coronary intervention (PCI) in the last
- •6 weeks before day of randomisation or planned PCI/cardiac surgery.
- •5.Haemodynamically unstable condition as judged by the investigator.
- •6.NYHA class 3 or 4.
- •7.Left ventricular ejection fraction <35 % (echocardiographic) or known moderately
- •or severely depressed systolic function (qualitative echocardiographic
- •measurement).
- •8.Clinically significant sinus and/or AV node dysfunction.
- •9.Bradycardia <40 beats per minutes (bpm), measured as the mean heart rate
- •during 30 seconds.
- •10.Hypotension (systolic BP <90 mm Hg).
- •11.Any clinically significant valvular heart disease.
- •12.Known hypertrophic cardiomyopathy/significant left ventricular hypertrophy (free
- •wall or septal thickness >13 mm).
- •13.QTc (Bazett) >450 ms (when measured during AF, the mean heart rate should
- •preferably be 50-100 bpm. The QTcB should be calculated at AF as the mean of
- •at least 5 consecutive RR intervals with consecutive QT intervals).
- •14.Any QRS duration >150 ms.
- •15.Bifascicular blocks: complete left bundle branch block (LBBB) or complete right
- •bundle branch block (RBBB) in combination with left anterior hemiblock (LAH) or
- •left posterior hemiblock (LPH).
- •16.Known history of Torsade de Pointes (TdP).
- •17.Known family history of long QT syndrome, Brugada syndrome or unexplained
- •sudden death below the age of 45 years.
- •18.Pacemaker.
- •19.Known preexcitation with (WPW syndrome) or without arrhythmias.
- •20.Concomitant medication with drug(s) prolonging the action potential duration
- •21.Serum or plasma potassium <3.8 mmol/L or >5.0 mmol/L.
- •22.Untreated hyperthyroidism/untreated hypothyroidism.
- •23.Haemoglobin <100 g/L.
- •24.Clinically important hepatic and/or renal dysfunction as judged by the investigator.
- •25.Any condition which in the opinion of the investigator would render the patient
- •unsuitable for inclusion in the study.
- •26.Participation in another intervention trial during the last 30 days before
- •enrolment, or previously enrolled or randomised in the present study.
- •27.Involvement in the planning and conduct of the study (applies to both
- •AstraZeneca staff or staff at the investigational site).
研究者
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