European Multinational Prolongation Registry on Prevention of Thromboembolic Events in Atrial Fibrillatio
- Conditions
- I48MedDRA - 10003658 Atrial fibrillationAtrial fibrillation and flutter
- Registration Number
- DRKS00005996
- Lead Sponsor
- Daiichi Sankyo Europe GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 4171
Inclusion Criteria
At least 18 years of age;
-Written informed consent for participation in the registry;
-History of non-valvular AF documented by electrical tracing (ECG, holter, pacemaker, implantable cardioverter defibrillator) within the prior 12 months;
-Treated with NOAC or VKA;
Exclusion Criteria
Patients with mechanical valve replacements or moderate, moderately severe or severe mitral stenosis are not allowed to be enrolled.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the long-term use of NOACs and corresponding prescription patterns, including reasons for switching from VKAs to NOACs.
- Secondary Outcome Measures
Name Time Method To gain insight on the long-term management of patients with atrial fibrillation (AF), treated with either NOACs or VKAs, with focus on the prevention of thromboembolic events. <br>To assess selected complications related to oral anticoagulants prescribed in AF, in particular bleeding.<br>To explore the relationship between anticoagulants and duration of therapy, adherence to therapy, resource utilization, estimated costs, treatment satisfaction, and health related quality of life, and clinical outcomes.<br><br>All the above mentioned objectives will be measured one year after baseline visit via a EQ-5D-5L and PACT-Q2. Also diaries will be distributed to the patients to record their contact with physician, nurse or other facilities throughout the year. <br>