Clinical trial NCT04519944: Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
Official title: Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention - German Non-interventional Study (ENCOURAGE-AF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation
Antiplatelet therapy
Anticoagulation therapy
Percutaneous coronary intervention
Edoxaban
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Deutschland GmbH
First posted: 2020-08-20
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will review database on 1200 participants with NVAF treated with Edoxaban in approximately 60 hospitals in Germany. All participants meeting the inclusion criteria and having given written informed consent will be enrolled. At least 25% of the participants should have acute coronary syndrome (ACS).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Usage of Peri- and Post-procedural Anticoagulation and Antiplatelet Therapy in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
timeFrame: Up to 1 year follow up after PCI
Secondary outcomes:
measure: Number of Participants Reporting Clinical Events of Interest in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
timeFrame: Up to 1 year follow up after PCI
measure: EQ-5D-5L Assessment in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
timeFrame: Up to 1 year follow up after PCI
measure: Number of Hospital Admissions in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
timeFrame: Up to 1 year follow up after PCI
measure: Duration of Hospital Admission in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
timeFrame: Up to 1 year follow up after PCI
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bad Friedrichshall
country: Germany
facility: SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG
city: Berlin
country: Germany
facility: Charité - Campus Mitte
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bonn
country: Germany
facility: GFO-Kliniken, Standort St.-Marienhospital Bonn
city: Brandenburg
country: Germany
facility: StädtischesKlinikum Brandenburg
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Coburg
country: Germany
facility: REGIOMED-KLINIKEN GmbH, Klinikum Coburg
city: Demmin
country: Germany
facility: Kreiskrankenhaus Demmin GmbH
city: Detmold
country: Germany
facility: Klinikum Lippe Detmold
city: Dortmund
country: Germany
facility: St. Johannes-Hospital Dortmund
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden
city: Eggenfelden
country: Germany
facility: Krankenhaus Eggenfelden
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Klinikum Frankfurt Höchst GmbH
city: Frankfurt
country: Germany
facility: CCB Cardioangiologisches Centrum Bethanien
city: Freiburg
country: Germany
facility: Universitäts Herzzentrum Freiburg Bad Krozingen
city: Fürth
country: Germany
facility: Klinikum Fürth
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald
city: Gutersloh
country: Germany
facility: Klinikum Gütersloh
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Asklepios Kliniken Hamburg GmbH - Aklepios Klinik Barmbek
city: Harburg
country: Germany
facility: Asklepios Klinikum Harburg
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn
city: Husum
country: Germany
facility: Klinikum Nordfriesland
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin
city: Köln
country: Germany
facility: Krankenhaus der Augustinerinnen Köln
city: Köln
country: Germany
facility: St. Vinzenz-Hospital Köln
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk gGmbH
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Ludenscheid
country: Germany
facility: Klinikum Lüdenscheid, Märkische Gesundheitsholding GmbH & Co. KG
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: Lübeck
country: Germany
facility: UKSH Lübeck
city: Merseburg
country: Germany
facility: Carl-von-Basedow-Klinik Saalekreis GmbH
city: München
country: Germany
facility: Technische Universität München, Klinikum rechts der Isar
city: München
country: Germany
facility: München Klinik gGmbH, Klinik Neuperlach
city: Münster
country: Germany
facility: St. Franziskus-Hospital GmbH
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Kardiologie
city: Paderborn
country: Germany
facility: St. Vincenz Krankenhaus
city: Quedlinburg
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben GmbH
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Rotenburg An Der Fulda
country: Germany
facility: Herz-Kreislauf-Zentrum Rotenburg
city: Schweinfurt
country: Germany
facility: Leopoldina
city: Stadtlohn
country: Germany
facility: Klinikum Westmünsterland GmbH
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus GmbH
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl, Innere Medizin I
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Volklingen
country: Germany
facility: Herzzentrum Saar
city: Weiden
country: Germany
facility: Kliniken Nordoberpfalz AG
city: Weinheim
country: Germany
facility: GRN-Klinik Weinheim
city: Wilhelmshaven
country: Germany
facility: Klinikum Wilhelmshaven gGmbH
city: Wuppertal
country: Germany
facility: Petrus-Krankenhaus Wuppertal
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Zwickau
country: Germany
facility: Heinrich-Braun-Klinikum Zwickau
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: