Non-valvular Atrial Fibrillation
Conditions
Keywords
Non-valvular atrial fibrillation, Antiplatelet therapy, Anticoagulation therapy, Percutaneous coronary intervention, Edoxaban
Brief summary
This study is designed to gain real-world clinical data on the peri- and post-procedural usage of anticoagulation and antiplatelet therapy in patients with non-valvular atrial fibrillation (NVAF) undergoing successful percutaneous coronary intervention (PCI) treated with edoxaban.
Detailed description
The study will assess real-world evidence data of anticoagulation and antiplatelet therapy in patients with NVAF undergoing PCI treated with edoxaban. The observation period will start 4 to 72 hours after removal of the guiding catheter of successful PCI in a hospital and ends 1 year after procedure. Follow-up telephone calls will take place approximately 1 month and 1 year after PCI. Real-world data of effectiveness of edoxaban and antiplatelet therapy, clinical events of interests, safety and quality of life (QoL) data of edoxaban will be collected.
Interventions
DRUGEdoxaban
This is an observational, prospective study; no treatment will be administered.
Sponsors
Daiichi Sankyo Deutschland GmbH
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age * Providing written informed consent (ICF) for participation in the study * NVAF treated with edoxaban * Successful PCI * No planned elective cardiac intervention for the whole duration of the study (up to 1 year) * Capability of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year) * Availability of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year) * Willingness of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year) * Not simultaneously participating in any interventional study * Life expectancy \> 1 year
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Usage of Peri- and Post-procedural Anticoagulation and Antiplatelet Therapy in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention | Up to 1 year follow up after PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Clinical Events of Interest in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention | Up to 1 year follow up after PCI | Bleeding (major, minor, CRNM), stroke, myocardial infarction (MI), percutaneous coronary intervention (PCI), and death will be assessed. |
| EQ-5D-5L Assessment in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention | Up to 1 year follow up after PCI | — |
| Number of Hospital Admissions in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention | Up to 1 year follow up after PCI | — |
| Duration of Hospital Admission in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention | Up to 1 year follow up after PCI | — |
Countries
Germany
Outcome results
None listed