Non permanent Atrial fibrillation MedDRA version: 12.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation
Conditions
Interventions
Trade Name: Multaq 400 mg film-coated tablets
Product Name: Multaq 400 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
Sponsors
sanofi-aventis Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Clinically stable patients with a history of, or current, symptomatic non-permanent Atrial Fibrillation (AF) in whom anti-arrhythmic treatment is indicated • Patients able to understand the patient information leaflet and sign the Informed Consent form for this study protocol • Patients aged = 18 years • Documented AF within the last 6 months prior to inclusion or at the time of inclusion • Documented sinus rhythm within the last 6 months prior to inclusion or at the time of inclusion 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: Criteria stated in the Summary of Product Characteristics ------------------------------------------------------------------------ • Hypersensitivity to the active substance or to any of the excipients • Second- or third-degree atrio-ventricular block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) • Bradycardia 5.5 mmol/l), or magnesium imbalance must be corrected before inclusion • Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose mal-absorption • Treatment with other class I or III anti-arrhythmic drugs which cannot be discontinued • Pregnancy • Breastfeeding women General Criteria -------------------- • Clinically relevant gastro-intestinal, psychiatric, or neurological disease • Women of childbearing potential without adequate birth control (e.g. oral contraception or intra-uterine device [IUD]), not menopaused, not sterile, or not hysterectomized • Participation in the preceding 2 months or current participation in another clinical trial with an investigational (under development) drug, or with an investigational device • Inability to follow the protocol requirements • Patient unable or unwilling to complete the Quality of Life questionnaires • Patient unable or unwilling to participate in the Holter monitoring procedure • Any non-cardiovascular illness or disorder that could preclude participation or severely limit survival Criteria linked to cardiac condition ------------------------------------------- • Patients with asymptomatic Atrial Fibrillation • Patients unwilling to start with or change anti-arrhythmic therapy • Patients already treated with dronedarone during the preceding 6 months • Planned major non-cardiac or cardiac surgery, or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or on urgent cardiac transplantation list • 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) •Patients known to have chronic AF defined as permanent AF for more than 6 months • Ablated patients • Unstable angina pectoris (ischemic symptoms during the last 7 days), or recent myocardial infarction (< 6 weeks) • First-degree family history of sudden cardiac death below age of 50 years in the absence of coronary heart disease • Ongoing potentially dangerous symptoms when in AF, such as angina pe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the change in quality of life defined as change in SF-36 Physical Component Summary Scale Score after 3 months of treatment;Secondary Objective: • To evaluate the change in quality of life defined as change in SF-36 Physical Component Summary Scale Score after 6 months of treatment • To evaluate the change in quality of life defined as change in the EQ-5D Descriptive System Score, EQ-5D Visual Analogue Scale Score and SF-36 Mental Component Summary Scale Score after 3 and 6 months of treatment • To evaluate AF recurrence • To assess safety;Primary end point(s): Primary Endpoint: ============= • Change in quality of life, defined as change in the SF-36 Physical Component Summary Scale Score after 3 months of treatment | — |
Countries
Belgium
Outcome results
None listed