EUCTR2011-002789-18-IT进行中（未招募）不适用
A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Dose-Ranging Phase II Study Assessing Ranolazine in the Maintenance of Sinus Rhythm after Electrical Cardioversion in Patients with Non-Permanent Atrial Fibrillation - RAFFAELLO
MENARINI RICERCHE S.P.A.0 个研究点目标入组 240 人开始时间: 2012年3月1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
- 240
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. Male or female patients 18 years and older; 2. Patients with persistent Atrial Fibrillation suitable for electrical direct current cardioversion (DCC); 3. A female of childbearing potential may be enrolled providing she: - has a negative pregnancy test at baseline and - is routinely using an effective method of birth control resulting in a low failure rate (e.g.. hormonal contraception, intrauterine device, condoms in combination with a spermicidal cream, total sexual abstinence or sterilisation) until end of study which corresponds to the follow-up safety call, 2 weeks after end of treatment; 4. Able to give written informed consent before any study related procedure; 5. Able to attend all the visits scheduled in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1. Patients with first diagnosed Atrial Fibrillation (namely first onset of AF irrespective of duration of arrhythmia or presence and severity of Atrial Fibrillation related symptoms) or patients with paroxysmal Atrial Fibrillation (namely self-terminating Atrial Fibrillation usually within 48 hours although it may continue for up to 7 days); 2. Patients with long-standing persistent Atrial Fibrillation (for this protocol defined as Atrial Fibrillation longer than 6 months) or permanent Atrial Fibrillation (i.e. Atrial Fibrillation accepted by the patient and by the physician); 3. Patients having known concurrent temporary secondary causes of Atrial Fibrillation such as alcohol intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia, acute pericarditis or myocarditis; 4. Patients having undergone atrial catheter ablation for Atrial Fibrillation; 5. Patients carrying a pacemaker; 6. Patients with electrolytes imbalances that may cause cardiac arrhythmias, e.g. potassium < 3.5 mmol/L or > 5.5 mmol/L; 7. Patients with severe renal impairment (creatinine clearance < 30 ml/min); 8. Patients with ALT or AST > 2.5x upper limits of normal at screening or severe hepatic impairment of any kind; 9. Patients taking potent CYP3A4 inhibitors (e.g. Itraconazole, Ketoconazole, Voriconazol, Posaconazol, HIV protease inhibitors, Clarithromycin, Telithromycin, Nefazodone); 10. Patients taking CYP3A4 inducers (e.g. Rifampicin, Phenytoin, Phenobarbital, Carbamazepine, St. John’s Wort); 11. Patients taking class I or Class III antiarrhythmic agents within 3 days of planned randomisation. NOTE: intravenous flecainide or propafenone are allowed up to 72 hours and 24 hours from the planned randomisation, respectively; 12. Patients taking beta-blockers unless used on stable doses for at least 2 weeks prior to the planned randomisation; 13. Patients taking Dronedarone or oral Amiodarone within 2 weeks and 3 months of planned randomisation, respectively. NOTE: Intravenous administration of Amiodarone is prohibited within 72 hours from planned randomisation; 14. Patients with a history of ECG abnormalities that in the opinion of the Investigator render the subject unsuitable for the trial, including history of congenital or a family history of long QT syndrome and a QTc interval =500 msec at Screening; 15. Patients with congestive heart failure NYHA grade III and IV; 16. Patients known to be hypersensitive to Ranolazine or to any of the components of the formulation; 17. Pregnant or breast feeding women; 18. Patients with any serious intercurrent illness (including psychiatric and neurological disorders) which, in the opinion of the Investigator, is incompatible with the protocol; 19. Abuse of alcohol (>350 g ethanol/week), analgesics, or psychotropic drugs; 20. Patients concurrently participating in another study, or who have received an investigational drug within 30 days prior to screening; 21. Patients unable to communicate well with the Investigator and to comply with the requirements of the entire study.
研究者
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