EUCTR2006-003211-40-BE进行中（未招募）不适用
A Randomized Double-blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients with a Documented First Episode of Atrial Fibrillation. - FLEC-PO-NA-CACR-06-MC-M
aboratoires 3M Santé0 个研究点目标入组 320 人开始时间: 2006年12月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
- •Subjects are eligible for participation in the study if the following inclusion criteria are met:
- •1. Willing to participate in the study,
- •2. Age between 18 and 65 years,
- •3. Willing to attend 10 outpatient visit during the course of the clinical study and to comply with the study requirements such as willing to undergo at least 8 ECGs, 3 Holters, and at least 2 weekly self ECG unit (heart scan) evaluations
- •4. History of one only symptomatic* and documented AF episode with duration > 1h and < 7 days which occurred during the 5 weeks prior to inclusion visit and terminated spontaneously or with medical treatment.
- •(*This episode should be the first and only one known and documented AF episode”. Symptom(s) should have been present for at least 1hour prior to and during the event record.)
- •5. Patient not on AAD at the time of recruitment
- •6. Patient must be in sinus rhythm at the time of treatment initiation.
- •7. Left ventricular ejection fraction > 40%, evaluated by a transthoracic echocardiogram, performed at the inclusion visit.
- •8. Females of child bearing potential must have a negative urine pregnancy test at the inclusion visit and at the end of study visits and be willing to use a medically acceptable method of contraception during the study.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from the study if any of the following apply:
- •1. History of more than one symptomatic documented AF episode
- •2. Persistent or permanent AF.
- •3. History of ablation for previous AF.
- •4. Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery).
- •5. Severe symptoms during AF episode (e.g.syncope, chest pain).
- •6. All types of treated arrhythmias other than AF
- •7. 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.
- •8. Left ventricular ejection fraction (LVEF) = 40%,
- •9. Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms,
- •10. Brugada symdrome,
- •11. Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block
- •12. 2nd or 3rd degree atrio ventricular block (AV block).
- •13. Sinus node dysfunction.
- •14. Severe hypertension with:
- •Systolic blood pressure = 180 mmHg, and / or
- •Diastolic blood pressure = 100 mmHg,
- •15. Left ventricular hypertrophy with septal thickness > 14 mm on Echocardiogram.
- •16. Implanted pacemaker.
- •17. Heart surgery within the last 6 months, or non stable postoperative condition,
- •18. Renal failure: serum creatinine = 150 µmol/l or creatinine clearance = 50 ml/min (Cockroft and Gault formula),
- •19. Uncorrected electrolytic abnormalities,
- •20. Have used recently in the last 3 months prior to the inclusion any of the following
- •treatments:
- •- Oral amiodarone,
- •- Treatment that lengthen QT (for example: Sultopride)
- •- Drugs causing torsades de pointe (e.g. mizolastine, pentamidine, sparfloxacin,
- •moxifloxacin)
- •- Bupropion
- •21. Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB).
- •22. Unable to read and understand study documents and/or cognitive or sensory limitations.
- •23. Are currently participating in another clinical study (with or without an investigational drug).
研究者
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