EUCTR2009-016818-24-PT进行中（未招募）不适用
A Randomized, international, multi-center, open-label study to document optimal timing of initiation of dronedarone TreatmEnt after conversion with loading dose of aMIodarone in patients with perSistent Atrial Fibrillation requiring conversion of AF - ARTEMIS AF Loading
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
- 768
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:
- •- Male or female adult aged 18 years or more,
- •- Outpatient,
- •- Patient with persistent AF for more than 72 hours (documented by an ECG taken within the last 72 hours) for whom cardioversion, anti-arrhythmic treatment and anticoagulation treatment are indicated in the opinion of the Investigator (Note: patient may already be on anticoagulation treatment),
- •- Naive of amiodarone treatment in the last three months prior to screening,
- •- QTcB < 500 ms on 12-lead ECG,
- •- Patient 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%),
- •- Signed written informed consent.
- •Inclusion Criteria: to be checked at randomization
- •- Outpatient (only hospitalization of 48h for a planned cardio-version will be allowed),
- •- Patient 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 one hour before randomization),
- •- Patient under effective oral anticoagulation according to ACC/AHA/ESC 2006 guidelines.
- •- QTcB < 500 ms and PR < 280 ms on 12-lead ECG,
- •- Patient having received 28 days ± 2 days of amiodarone.
- •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:
- •- Contraindication to oral anticoagulation,
- •- Any 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),
- •- Patient with permanent AF in which cardioversion has failed,
- •- Patient with paroxysmal AF in whom cardioversion is not indicated,
- •- Bradycardia < 50 beats per minute (bpm) at rest on the 12-lead ECG,
- •- 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 patient in unstable hemodynamic conditions.
- •- 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,
- •- Pregnant women,
- •- Breastfeeding women,
- •- Previous (2 preceding months) or current participation in another clinical trial with an investigational drug or with an investigational device,
- •- Clinically relevant hematologic, underlying hepatobiliary disease, gastrointestinal, pulmonary, endocrinologic, psychiatric, neurological or dermatological disease,
- •- Severe hepatic impairment,
- •- Severe renal impairment (creatinine clearance < 30 mL/min),
- •- Serum potassium <3.5 millimol/liter (mmol/L) (in patients with hypokalemia, potassium deficiency must be corrected before randomization) or > 5.5 mmol/l,
- •- Magnesemia < 0.8 mml/l (in patient with hypo-magnesemia, magnesium deficiency must be corrected before randomization),
- •- Unstable angina pectoris (ischemic symptoms during the last 7 days) or recent myocardial infarction (MI) (< 6 weeks),
- •- First degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease,
- •- Second- or third- degree Atrio-Ventricular block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker),
- •- Ongoing potentially severe symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator,
- •- Wolff-Parkinson-White Syndrome,
- •- Previous ablation for atrial fibrillation or any planned ablation in the next following 2 months.
- •Exclusion criteria to be checked at randomization
- •- Bradycardia < 50 bpm on the 12-lead ECG before randomization,
- •- 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.
- •- Serum potassium <3.5 millimol/liter (mmol/L) (in patients with hypokalemia, potassium deficiency must have been corrected before randomization) or > 5.5 mmol/l,
- •- Magnesemia < 0.8 mml/l (in patient with hypo-magnesemia, magnesium deficiency must have been corrected before randomization)
- •- 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,
研究者
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