EUCTR2005-000204-13-DE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
适应症
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 at randomisation. In patients with documented persistent AF, ie, they have previously undergone cardioversion for persistent (not paroxysmal) AF, the current episode could be between 8 h and 90 days at randomisation.
- •4.Effective oral anticoagulation with International Normalized Ratio (INR) >2 for 3 consecutive weeks at randomisation (if there are more stringent country specific guidelines, these can be utilised), or a TEE without any finding of intracardial thrombus or signs of thrombogenecity.
- •5.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.Cardioversion of AF/AFl within 4 weeks at randomisation, or unsuccessful cardioversion of current AF episode
- •2.Women of childbearing potential (only postmenopausal or surgically sterilised
- •women may be included).
- •3.Ongoing type I (counter-clockwise or clockwise) AFl.
- •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 congestive heartfailure.
- •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 <50 beats per minutes (bpm) during AF, 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.History of Torsade de Pointes or any other polymorphic ventricular tachycardia. History of sustained monomorphic ventricular tachycardia.
- •17.History of unexplained syncope, long QT syndrome or Brugada syndrome. Family history of long QT syndrome or unexplained sudden death below the age of 45 years.
- •18.Pacemaker or implantable cardioverter-defibrillator.
- •19.Known preexcitation with (WPW syndrome) or without arrhythmias.
- •20.Concomitant medication with drug(s) prolonging the action potential duration
- •21.Serum potassium <3.8 mmol/L or >5.0 mmol/L or plasma potassium <3.6mmol/L or >5.0 mmol/L..
- •22.Untreated hyperthyroidism/untreated hypothyroidism.
- •23.Haemoglobin <100 g/L.
- •24. Clinically important hepatic dysfunction (ASAT, ALAT >3xULN(Upper Limit of Normal)) and/or renal dysfunction (calculated creatinine clearance <30 mL/min).
- •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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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 fibrillatioEUCTR2005-000204-13-DKAstraZeneca AB160