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
- Conditions
- Persistant atrial fibrillation requiring conversion of AFMedDRA version: 12.1Level: PTClassification code 10003658Term: Atrial fibrillation
- Registration Number
- EUCTR2009-016818-24-FR
- Lead Sponsor
- sanofi aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 768
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
•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,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method