NCT00408473终止4 期
A Randomised Double-blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients With a Documented First Episode of Atrial Fibrillation.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 256
- 试验地点
- 94
- 主要终点
- Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.
研究概览
简要总结
The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in the prevention of recurrent AF during 9 months of active treatment compared to placebo in patients with only one documented AF episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of first symptomatic & documented episode of AF
- •LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
排除标准
- •History of more than 1 symptomatic documented AF episode, persistent or permanent AF.
- •History of ablation for previous AF
- •Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery
- •Severe symptoms during AF episode (e.g.syncope, chest pain)
- •All types of treated arrhythmias other than AF
- •History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases
- •Left ventricular ejection fraction (LVEF) ≤ 40%
- •Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms
- •Brugada syndrome
- •Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block
- •2nd or 3rd degree atrioventricular (AV) block
- •Sinus node dysfunction
- •Severe hypertension with:Systolic blood pressure ≥ 180 mmHg, and / or· Diastolic blood pressure ≥ 100 mmHg
- •Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram
- •Implanted pacemaker
- •Heart surgery within the last 6 months, or non-stable postoperative condition
- •Renal failure: serum creatinine ≥ 150 µmol/l or creatinine clearance ≤ 50 ml/min (Cockroft and Gault formula
- •Uncorrected electrolytic abnormalities
- •Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion
- •Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB
结局指标
主要结局
Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or "Self ECG unit" recording.
次要结局
- Number of emergency admissions due to AF recurrence
- Cardiac Safety
- Total number of AF recurrences during the treatment period
- Total number of patients in sinus rhythm at the end of the study
- AF Burden
研究者
研究点 (94)
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