EUCTR2021-004865-11-GR进行中（未招募）1 期
Comparison of the effectiveness of IntraVenous FLECainide plus oral ranolazineversus intravenous flecainide alone in the cardioversion of recent onset atrialfibrillation – a randomized, prospective, multicentre, open study, the IV-FLEC study - IV-FLEC
Win Medica Pharmaceuticals S.A.0 个研究点目标入组 210 人开始时间: 2022年3月17日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- •Patients can only be included in the study if they meet all of the following
- •1. Patients aged =18 years
- •2. Patients with electrocardiographically confirmed AF, with recent onset
- •(self-reported onset of arrhythmia within 48 hours of starting medication
- •reorganization).
- •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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •Patients will be excluded from the study if they meet any of the
- •have the following criteria:
- •1. Coronary heart disease and / or significant structural heart disease
- •2. Cardiogenic shock
- •3. Heart failure, or reduced systolic function left ventricle (ejection fraction <55%)
- •4. Hypotension (systolic blood pressure <100mmHg)
- •5. Previous treatment with ranolazine within previous 48 hours.
- •6. Atrial fibrillation disorder [(2nd degree atrioventricular block, biceps block (RBBB + LAH or RBBB + LPH), or left arm block (LBBB)}, or absent sinus syndrome
- •7. Hemodynamically intolerant AF
- •8. Creatinine clearance less than or equal to 30ml / min
- •9. Moderate or severe hepatic impairment
- •10. Extended QTc interval (corrected QT> 460ms)
- •11. Recent treatment with antiarrhythmic drugs category Ic within the previous 24 hours or with amiodarone within the previous 6 months
- •12. Co-administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, klarithromycin, telithromycin, nefazodone)
- •13. Known Brugada syndrome
- •14. Pregnant or breastfeeding women
- •15. Hypersensitivity to flecainide (flecainide acetate) or to
- •ranolazine or any of the excipients
研究者
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