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NCT04519944 Clinical Trial

Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

Non-valvular Atrial Fibrillation Clinical Trial

— ENCOURAGE-AF  

Official title:
Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention - German Non-interventional Study (ENCOURAGE-AF)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04519944
Other study ID # DS-EDO-01-20-DE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2020
Est. completion date July 6, 2023

Study information
Verified date July 2023
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 666
Est. completion date July 6, 2023
Est. primary completion date July 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Edoxaban
This is an observational, prospective study; no treatment will be administered.

Locations
Country Name City State
Germany Zentralklinik Bad Berka Bad Berka
Germany SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald Bad Friedrichshall
Germany Kerckhoff-Klinik GmbH Bad Nauheim
Germany Herz- und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen
Germany Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG Bad Rothenfelde
Germany Charité - Campus Benjamin Franklin Berlin
Germany Charité - Campus Mitte Berlin
Germany Deutsches Herzzentrum Berlin Berlin
Germany GFO-Kliniken, Standort St.-Marienhospital Bonn Bonn
Germany StädtischesKlinikum Brandenburg Brandenburg
Germany Klinikum Braunschweig Braunschweig
Germany Klinikum Chemnitz Chemnitz
Germany REGIOMED-KLINIKEN GmbH, Klinikum Coburg Coburg
Germany Kreiskrankenhaus Demmin GmbH Demmin
Germany Klinikum Lippe Detmold Detmold
Germany St. Johannes-Hospital Dortmund Dortmund
Germany Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden Dresden
Germany Krankenhaus Eggenfelden Eggenfelden
Germany Universitätsklinikum Essen Essen
Germany CCB Cardioangiologisches Centrum Bethanien Frankfurt
Germany Klinikum Frankfurt Höchst GmbH Frankfurt am Main
Germany Universitäts Herzzentrum Freiburg Bad Krozingen Freiburg
Germany Klinikum Fürth Fürth
Germany SRH Wald-Klinikum Gera Gera
Germany Universitätsklinikum Greifswald Greifswald
Germany Klinikum Gütersloh Gutersloh
Germany Asklepios Klinik St. Georg Hamburg
Germany Asklepios Kliniken Hamburg GmbH - Aklepios Klinik Barmbek Hamburg
Germany Asklepios Klinikum Harburg Harburg
Germany SLK-Kliniken Heilbronn Heilbronn
Germany Klinikum Nordfriesland Husum
Germany Universitätsklinikum Jena Jena
Germany SRH Klinikum Karlsbad-Langensteinbach GmbH Karlsbad
Germany Universitätsklinikum Schleswig-Holstein - Campus Kiel Kiel
Germany Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin Koblenz
Germany Evangelisches Krankenhaus Kalk gGmbH Köln
Germany Krankenhaus der Augustinerinnen Köln Köln
Germany St. Vinzenz-Hospital Köln Köln
Germany Universitätsklinikum Köln Köln
Germany Universitätsklinikum Leipzig Leipzig
Germany UKSH Lübeck Lübeck
Germany Klinikum Lüdenscheid, Märkische Gesundheitsholding GmbH & Co. KG Ludenscheid
Germany Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen
Germany Carl-von-Basedow-Klinik Saalekreis GmbH Merseburg
Germany München Klinik gGmbH, Klinik Neuperlach München
Germany Technische Universität München, Klinikum rechts der Isar München
Germany St. Franziskus-Hospital GmbH Münster
Germany Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Kardiologie Oldenburg
Germany St. Vincenz Krankenhaus Paderborn
Germany Harzklinikum Dorothea Christiane Erxleben GmbH Quedlinburg
Germany Universitätsmedizin Rostock Rostock
Germany Herz-Kreislauf-Zentrum Rotenburg Rotenburg An Der Fulda
Germany Leopoldina Schweinfurt
Germany Klinikum Westmünsterland GmbH Stadtlohn
Germany Robert-Bosch-Krankenhaus GmbH Stuttgart
Germany SRH Zentralklinikum Suhl, Innere Medizin I Suhl
Germany Krankenhaus der Barmherzigen Brüder Trier Trier
Germany Universitätsklinikum Tübingen Tübingen
Germany Universitätsklinikum Ulm Ulm
Germany Herzzentrum Saar Volklingen
Germany Kliniken Nordoberpfalz AG Weiden
Germany GRN-Klinik Weinheim Weinheim
Germany Klinikum Wilhelmshaven gGmbH Wilhelmshaven
Germany Petrus-Krankenhaus Wuppertal Wuppertal
Germany Universitätsklinikum Würzburg Würzburg
Germany Heinrich-Braun-Klinikum Zwickau Zwickau

Sponsors (2)
Lead Sponsor Collaborator
Daiichi Sankyo, Inc. Daiichi Sankyo Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Number of Participants Reporting Clinical Events of Interest in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention Bleeding (major, minor, CRNM), stroke, myocardial infarction (MI), percutaneous coronary intervention (PCI), and death will be assessed. Up to 1 year follow up after PCI
Secondary EQ-5D-5L Assessment in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention Up to 1 year follow up after PCI
Secondary Number of Hospital Admissions in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention Up to 1 year follow up after PCI
Secondary Duration of Hospital Admission in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention Up to 1 year follow up after PCI
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Completed NCT04722679 - A Study to Collect Information on the Characteristics of Elderly Belgian Patients With NVAF That Are Treated With a NOAC for This Indication With a Special Focus on Their Fear of Bleeding While Using a NOAC vs the Clinical Benefit of a NOAC of Thrombosis/Stroke Prevention.
Completed NCT04297072 - Study to Gather Information on the Kidney Function of Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem) Treated With Rivaroxaban or Vitamin K Antagonists
Recruiting NCT05320627 - Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation Phase 4
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Completed NCT02488421 - Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF2 N/A