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
- Conditions
- atrial fibrillationcardiac arrythmia10007521
- Registration Number
- NL-OMON36400
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
•Inclusion criteria at screening:;- Male or female adult aged 18 years or more, ;- 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 ;- Signed written informed consent.;•Inclusion Criteria: to be checked at randomization;- Outpatient and Inpatient. (except patients hospitalized during screening period for SAE).;- 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 anticoagulation according to ACC/AHA/ESC AF treatment;guidelines [18] verified by INR (target > 2).;INR should be closely monitored after initiating dronedarone in patients taking vitamin K antagonist as per their label;- QTcB < 500 ms and PR < 280 ms on 12-lead ECG,;- Patient having received 28 days ± 2 days of amiodarone.
•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 defined as patients with an AF duration >= 6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician.;- 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:;o with New York Heart Association (NYHA) class III and IV heart failure, ;o with LVEF < 35%,;o or NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic, ;o as 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:;o with New York Heart Association (NYHA) class III and IV heart failure, ;o with LVEF < 35%,;o or NYHA class II with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic, ;o as 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,;- Severe hepatic impairment.;- Patients with permanent AF defined as pa
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Evaluate the rate of AF recurrences one month after randomization according to<br /><br>different timings of initiation of dronedarone. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Evaluate the rate of AF recurrences two months after randomization,<br /><br>Assess the safety of the change from amiodarone to dronedarone and dronedarone<br /><br>safety.<br /><br>Explore dronedarone and SR35021 (active metabolite) plasma levels according to<br /><br>different timings of initiation,<br /><br>Explore potential PK interaction between dronedarone and amiodarone.</p><br>