EUCTR2010-019247-19-DK进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
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. 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,
- •I03. Requiring a change from amiodarone treatment whatever the reason, but without liver, lung or thyroid toxicity related to previous use of amiodarone
- •I04.Patients with at least one cardiovascular risk factor (i.e. age > 70, hypertension, diabetes, prior cerebrovascular disease or left atrial diameter = 50 mm
- •I05. Patients receiving effective anticoagulation according to ACC/AHA/ESC guidelines, verified by INR (target INR > 2),
- •I06. QTcB < 500 ms on 12-lead ECG,
- •I07. Signed written informed consent.
- •Inclusion Criteria: to be checked before randomization
- •I08. 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),
- •I09. Patients under effective anticoagulation according to ACC/AHA/ESC AF treatment Guidelines, verified by INR ( target > 2),
- •INR should be closely monitored after initiating dronedarone in patients taking vitamin K antagonist as per their label.
- •I10. QTcB < 500 ms and PR < 280 ms on 12-lead ECG,
- •I11. Outpatient and Inpatient (except patients hospitalized during screening period for SAE).
- •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 defined as patients with an AF duration = 6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician.
- •E04. Bradycardia < 50 beats per minute (bpm) at rest on the 12-lead ECG,
- •E05.•History of, or current heart failure or left ventricular systolic function
- •Patients with 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. Patients with a second or third degree Atrio-Ventricular block, with a complete bundle branch block, a distal block, a sinus node dysfunction, atrial conduction defects or a sick sinus syndrome (except when a functioning pacemaker is in place)
- •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. •History of, or current heart failure or left ventricular systolic dysfunction
- •Patients with 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. Magnesemia < 0.8 mml/l (in patient with hypo-magnesemia, magnesium defi
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