2024-514677-22-00招募中3 期
Comparison of the effectiveness of IntraVenous FLECainide plus oral ranolazine versus intravenous flecainide alone in the cardioversion of recent onset atrial fibrillation - a randomized, prospective, multicentre, open-label study, the IV-FLEC study.
Win Medica Pharmaceutical A.E.13 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年9月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 13
- 主要终点
- Percentage of patients with recent onset (<48 hours) AF who were restored to sinus rhythm within 3 hours of starting treatment with IV flecainide and PO ranolazine compared with IV flecainide monotherapy.
研究概览
简要总结
The aim of this study is to compare the effectiveness of combined antiarrhythmic therapy with IV flecainide and PO ranolazine versus IV flecainide monotherapy in restoring sinus rhythm in patients with recent onset (<48 hours) AF.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years
- •Patients with electrocardiographically confirmed AF with recent onset (self-reported onset of arrhythmia within 48 hours of starting pharmacological cardioversion).
排除标准
- •Coronary artery disease and/or significant structural heart disease
- •Prolonged QTc interval (corrected QT> 460ms)
- •Recent treatment with class Ic antiarrhythmic drugs within the previous 24 hours or with amiodarone within the previous 6 months
- •Co-administration of strong CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone)
- •Known Brugada syndrome
- •Pregnant or breastfeeding women
- •Hypersensitivity to flecainide (flecainide acetate) or ranolazine or any of the excipients
- •Cardiogenic shock
- •Heart failure, or decreased systolic function of the left ventricle (ejection fraction <55%)
- •Hypotension (systolic blood pressure <100mmHg)
- •Previous treatment with ranolazine within the previous 48 hours.
- •Atrioventricular conduction disorder [(2nd degree atrioventricular block, bundle branch block (RBBB + LAH or RBBB + LPH), or left bundle branch block (LBBB)}, or sick sinus syndrome in the absence of a pacemaker,
- •Hemodynamically intolerable AF
- •Creatinine clearance less than or equal to 30ml/min
- •Moderate or severe liver dysfunction
结局指标
主要结局
Percentage of patients with recent onset (<48 hours) AF who were restored to sinus rhythm within 3 hours of starting treatment with IV flecainide and PO ranolazine compared with IV flecainide monotherapy.
Percentage of patients with recent onset (<48 hours) AF who were restored to sinus rhythm within 3 hours of starting treatment with IV flecainide and PO ranolazine compared with IV flecainide monotherapy.
次要结局
- Time interval from initiation of treatment with IV flecainide and PO ranolazine versus IV flecainide monotherapy to restoration of sinus rhythm in patients with recent onset (<48 hours) AF
- Percentage of patients with recent onset (<48 hours) AF who were restored to sinus rhythm within 6 hours of starting treatment with IV flecainide and PO ranolazine compared with IV flecainide monotherapy.
研究者
Koufaki Giota
Scientific
Win Medica Pharmaceutical A.E.
研究点 (13)
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