MedDRA - 10003658 Atrial fibrillation I48
Conditions
Interventions
Group 1:
- only patients treated with NOAC or VKA
- Description of charakteristics of AF patients in terms of key (socio-)demographic data, risk factors, method of diagnosis, treatment modalities
- Retrospective documentation of events related to AF and anticoagulation therapy (within a 1 year period prior to inclusion)
- Assessment of quality of life at baseline (visit1)
- Prospective observation of patients with atrial fibrillation
- Prospective collection of outcome data
- Prospective assessment of quality of life at 1 year
- Assessment of selected complications related to (oral) anticoagulants prescribed in AF, in particular bleeding
- Information on treatment itensity, frequencies and resource use for pharmaco-economic analyses.
Sponsors
Daiichi Sankyo Europe GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: Patients with mechanical valve replacements or moderate, moderately severe or severe mitral stenosis are not allowed to be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the long-term use of NOACs and corresponding prescription patterns, including reasons for switching from VKAs to NOACs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. To assess selected complications related to oral anticoagulants prescribed in AF, in particular bleeding. 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. 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. | — |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Contacts
Public ContactPetra Laeis
Daiichi-Sankyo Europe GmbH, Clinical Operations
Outcome results
None listed