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

• Conditions: Paroxysmal or persistent atrial fibrillation; MedDRA version: 14.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-019247-19-CZ
• Lead Sponsor: sanofi aventis groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-29
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

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

Exclusion Criteria

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 defic

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified