EUCTR2010-019247-19-FR进行中（未招募）1 期
A Randomized, international, multi-center, open-label study to document pharmacokinetics and optimal timing of initiation of dronedarone TreatmEnt following long-term aMIodarone in patients with paroxysmal or perSistent Atrial Fibrillation whatever the reason for the change of treatment - ARTEMIS AF Long-Term
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
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
- •Inclusion criteria at screening:
- •I01. Male or female adults aged 18 years or more,
- •I02. Outpatients,
- •I03. Patients with paroxysmal or persistent AF having received at least 6 months of amiodarone before screening with at least the last 2 months at a regimen of 200 mg/day (during at least 5 days per week) prior to screening,
- •I04. Requiring a change from amiodarone treatment whatever the reason, but without major amiodarone-related toxicity (interstitial lung disease, thyroid or hepatotoxicity),
- •I05. Patients with at least one cardiovascular risk factor (i.e. age > 70, hypertension, diabetes, prior cerebrovascular disease, left atrial diameter = 50 mm or left ventricular ejection fraction [LVEF] < 40%),
- •I06. Patients receiving effective anticoagulation according to ACC/AHA/ESC guidelines,
- •I07. QTcB < 500 ms on 12-lead ECG,
- •I08. Signed written informed consent.
- •Inclusion Criteria: to be checked before randomization
- •I09. Patients in sinus rhythm (Note: if cardioversion is performed on Day 1 prior to randomization, then the patient must be in sinus rhythm for at least an hour before randomization),
- •I10. Patients under effective oral anticoagulation according to ACC/AHA/ESC 2006 guidelines, verified by INR (target > 2),
- •I11. QTcB < 500 ms and PR < 280 ms on 12-lead ECG,
- •I12. Outpatients (only hospitalization of 48h for a planned cardioversion will be allowed). Patients currently hospitalized for Serious Adverse Event (SAE) are not eligible for randomization.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria at screening:
- •E01. Contraindication to oral anticoagulation,
- •E02. Documented AF episode motivating inclusion in the study after an acute condition known to cause AF (e.g. alcohol intake, thyrotoxicosis, acute infection, pericarditis, pulmonary embolism, cardiac surgery),
- •E03. Patients with permanent AF in which cardioversion has failed,
- •E04. Bradycardia < 50 beats per minute (bpm) at rest on the 12-lead ECG,
- •E05. Clinically overt congestive heart failure:
- •owith New York Heart Association (NYHA) class III and IV heart failure,
- •oor NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic,
- •oor any patients in unstable hemodynamic conditions.
- •E06. Women of childbearing potential without adequate birth control (e.g. oral contraception or intra-uterine device [IUD]) or not menopaused, not sterile or not hysterectomized,
- •E07. Pregnant women,
- •E08. Breastfeeding women,
- •E09. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug or with an investigational device,
- •E10. Clinically relevant hematologic, underlying hepatobiliary disease, gastrointestinal, pulmonary, endocrinologic, psychiatric, neurological or dermatological disease,
- •E11. Severe hepatic impairment,
- •E12. Severe renal impairment (creatinine clearance < 30 mL/min),
- •E13. Serum potassium <3.5 millimol/liter (mmol/l) (in patients with hypokalemia, potassium deficiency must be corrected before randomization) or > 5.5 mmol/l,
- •E14. Magnesemia < 0.8 mml/l (in patient with hypo-magnesemia, magnesium deficiency must be corrected before randomization),
- •E15. Unstable angina pectoris (ischemic symptoms during the last 7 days) or recent myocardial infarction (MI) (< 6 weeks),
- •E16. First degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease,
- •E17. Second- or third- degree Atrio-Ventricular block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker),
- •E18. Ongoing potentially severe symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator,
- •E19. Wolff-Parkinson-White Syndrome,
- •E20. Previous catheter ablation for atrial fibrillation,
- •E21. Catheter ablation scheduled in the next 10 weeks,
- •E22. Previous history of amiodarone intolerance or toxicity,
- •E23. History of thyroid dysfunction,
- •E24. Hypersensitivity to dronedarone or any of the excipients,
- •E25. Patients previously treated with class I or class III anti-arrhythmic drugs (including sotalol) other than amiodarone if the anti-arrhythmic drug was taken less than one week before the day of screening (If taken more than one week before screening, the patient can be included),
- •E26. Patients in whom a contraindicated concomitant treatment is mandatory
- •Exclusion criteria to be checked before randomization
- •E27. Bradycardia < 50 bpm on the 12-lead ECG before randomization,
- •E28. Clinically overt congestive heart failure:
- •owith New York Heart Association (NYHA) class III and IV heart failure,
- •oor NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic,
- •oas well any patients in unstable hemodynamic conditions.
- •E29. Serum potassium <3.5 millimol/liter (mmol/l) (in patients with hypokalemia, potassium deficiency must be corrected before randomization) or > 5.5 mmol/l,
- •E30. Magnesemi
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