EUCTR2011-002789-18-GB进行中（未招募）1 期
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 - Ranolazine in AF following an electrical cardioversion
Menarini Ricerche S.p.A0 个研究点目标入组 240 人开始时间: 2012年2月14日最近更新:
适应症
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
- 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 AF suitable for electrical direct current
- •cardioversion (DCC);
- •NOTE: According to the ESC classification, persistent AF is defined as a
- •continuous AF with a minimum duration of 7 days or requiring
- •termination by cardioversion. Prior to randomisation, successful
- •electrical cardioversion and maintenance of sinus rhythm at 2 hours
- •shall be documented;
- •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 orsterilisation) 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
- •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 AF (namely first onset of AF irrespective
- •of duration of arrhythmia or presence and severity of AF related
- •symptoms) or patients with paroxysmal AF (namely self-terminating AF
- •usually within 48 hours although it may continue for up to 7 days);
- •2. Patients with long-standing persistent AF (for this protocol defined as
- •AF longer than 6 months) or permanent AF (i.e. AF accepted by the
- •patient and by the physician);
- •3. Patients having known concurrent temporary secondary causes of AF
- •such as alcohol intoxication, pulmonary embolism, hyperthyroidism,
- •pneumonia, hypoxemia, acute pericarditis or myocarditis;
- •4. Patients having undergone atrial catheter ablation for AF;
- •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
- •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
- •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.
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