Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
- Registration Number
- NCT04519944
- Lead Sponsor
- Daiichi Sankyo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 666
- ≥ 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
- Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NVAF patients undergoing PCI Edoxaban Patients with non-valvular atrial fibrillation (NVAF) who had successful percutaneous coronary intervention (PCI).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (66)
Zentralklinik Bad Berka
🇩🇪Bad Berka, Germany
Kerckhoff-Klinik GmbH
🇩🇪Bad Nauheim, Germany
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
🇩🇪Bad Friedrichshall, Germany
Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG
🇩🇪Bad Rothenfelde, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
🇩🇪Bad Oeynhausen, Germany
Charité - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
StädtischesKlinikum Brandenburg
🇩🇪Brandenburg, Germany
GFO-Kliniken, Standort St.-Marienhospital Bonn
🇩🇪Bonn, Germany
Klinikum Braunschweig
🇩🇪Braunschweig, Germany
REGIOMED-KLINIKEN GmbH, Klinikum Coburg
🇩🇪Coburg, Germany
Klinikum Lippe Detmold
🇩🇪Detmold, Germany
Kreiskrankenhaus Demmin GmbH
🇩🇪Demmin, Germany
St. Johannes-Hospital Dortmund
🇩🇪Dortmund, Germany
Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden
🇩🇪Dresden, Germany
Krankenhaus Eggenfelden
🇩🇪Eggenfelden, Germany
Universitäts Herzzentrum Freiburg Bad Krozingen
🇩🇪Freiburg, Germany
Klinikum Frankfurt Höchst GmbH
🇩🇪Frankfurt am Main, Germany
CCB Cardioangiologisches Centrum Bethanien
🇩🇪Frankfurt, Germany
Klinikum Fürth
🇩🇪Fürth, Germany
SRH Wald-Klinikum Gera
🇩🇪Gera, Germany
Universitätsklinikum Greifswald
🇩🇪Greifswald, Germany
Klinikum Gütersloh
🇩🇪Gutersloh, Germany
Asklepios Klinikum Harburg
🇩🇪Harburg, Germany
Asklepios Kliniken Hamburg GmbH - Aklepios Klinik Barmbek
🇩🇪Hamburg, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
SLK-Kliniken Heilbronn
🇩🇪Heilbronn, Germany
Klinikum Nordfriesland
🇩🇪Husum, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
🇩🇪Kiel, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
SRH Klinikum Karlsbad-Langensteinbach GmbH
🇩🇪Karlsbad, Germany
Krankenhaus der Augustinerinnen Köln
🇩🇪Köln, Germany
Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin
🇩🇪Koblenz, Germany
St. Vinzenz-Hospital Köln
🇩🇪Köln, Germany
Evangelisches Krankenhaus Kalk gGmbH
🇩🇪Köln, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
🇩🇪Ludwigshafen, Germany
UKSH Lübeck
🇩🇪Lübeck, Germany
Klinikum Lüdenscheid, Märkische Gesundheitsholding GmbH & Co. KG
🇩🇪Ludenscheid, Germany
Carl-von-Basedow-Klinik Saalekreis GmbH
🇩🇪Merseburg, Germany
München Klinik gGmbH, Klinik Neuperlach
🇩🇪München, Germany
St. Franziskus-Hospital GmbH
🇩🇪Münster, Germany
Technische Universität München, Klinikum rechts der Isar
🇩🇪München, Germany
Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Kardiologie
🇩🇪Oldenburg, Germany
St. Vincenz Krankenhaus
🇩🇪Paderborn, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH
🇩🇪Quedlinburg, Germany
Herz-Kreislauf-Zentrum Rotenburg
🇩🇪Rotenburg An Der Fulda, Germany
Universitätsmedizin Rostock
🇩🇪Rostock, Germany
Leopoldina
🇩🇪Schweinfurt, Germany
Robert-Bosch-Krankenhaus GmbH
🇩🇪Stuttgart, Germany
Klinikum Westmünsterland GmbH
🇩🇪Stadtlohn, Germany
SRH Zentralklinikum Suhl, Innere Medizin I
🇩🇪Suhl, Germany
Krankenhaus der Barmherzigen Brüder Trier
🇩🇪Trier, Germany
Herzzentrum Saar
🇩🇪Volklingen, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Kliniken Nordoberpfalz AG
🇩🇪Weiden, Germany
Klinikum Wilhelmshaven gGmbH
🇩🇪Wilhelmshaven, Germany
GRN-Klinik Weinheim
🇩🇪Weinheim, Germany
Petrus-Krankenhaus Wuppertal
🇩🇪Wuppertal, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Heinrich-Braun-Klinikum Zwickau
🇩🇪Zwickau, Germany
Charité - Campus Mitte
🇩🇪Berlin, Germany
Klinikum Chemnitz
🇩🇪Chemnitz, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany