Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ENCOURAGE-AF)

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

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.

Study Overview

• Status: Completed
• Conditions: Non-valvular Atrial Fibrillation
• Intervention / Treatment: Drug: 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.

• Study Type: Observational
• Enrollment (Actual): 666

Contacts and Locations

Study Locations

• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka
  • Bad Friedrichshall, Germany, 74177
    • SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik GmbH
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum Nordrhein-Westfalen
  • Bad Rothenfelde, Germany, 49214
    • Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Berlin, Germany, 12203
    • Charité - Campus Benjamin Franklin
  • Berlin, Germany, 10117
    • Charite - Campus Mitte
  • Bonn, Germany, 53115
    • GFO-Kliniken, Standort St.-Marienhospital Bonn
  • Brandenburg, Germany, 14770
    • StädtischesKlinikum Brandenburg
  • Braunschweig, Germany, 38126
    • Klinikum Braunschweig
  • Chemnitz, Germany, 09113
    • Klinikum Chemnitz
  • Coburg, Germany, 96450
    • REGIOMED-KLINIKEN GmbH, Klinikum Coburg
  • Demmin, Germany, 17109
    • Kreiskrankenhaus Demmin GmbH
  • Detmold, Germany, 32756
    • Klinikum Lippe Detmold
  • Dortmund, Germany, 44137
    • St. Johannes-Hospital Dortmund
  • Dresden, Germany, 01307
    • Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden
  • Eggenfelden, Germany, 84307
    • Krankenhaus Eggenfelden
  • Essen, Germany, 45122
    • Universitatsklinikum Essen
  • Frankfurt, Germany, 60389
    • CCB Cardioangiologisches Centrum Bethanien
  • Frankfurt am Main, Germany, 65929
    • Klinikum Frankfurt Höchst GmbH
  • Freiburg, Germany, 79106
    • Universitäts Herzzentrum Freiburg Bad Krozingen
  • Fürth, Germany, 90766
    • Klinikum Fürth
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera
  • Greifswald, Germany, 17475
    • Universitätsklinikum Greifswald
  • Gutersloh, Germany, 33332
    • Klinikum Gütersloh
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hamburg, Germany, 22307
    • Asklepios Kliniken Hamburg GmbH - Aklepios Klinik Barmbek
  • Harburg, Germany, 21075
    • Asklepios Klinikum Harburg
  • Heilbronn, Germany, 74708
    • SLK-Kliniken Heilbronn
  • Husum, Germany, 25813
    • Klinikum Nordfriesland
  • Jena, Germany, 07740
    • Universitatsklinikum Jena
  • Karlsbad, Germany, 76307
    • SRH Klinikum Karlsbad-Langensteinbach GmbH
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein - Campus Kiel
  • Koblenz, Germany, 56068
    • Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin
  • Köln, Germany, 50937
    • Universitätsklinikum Köln
  • Köln, Germany, 50678
    • Krankenhaus der Augustinerinnen Köln
  • Köln, Germany, 50733
    • St. Vinzenz-Hospital Köln
  • Köln, Germany, 51103
    • Evangelisches Krankenhaus Kalk gGmbH
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig
  • Ludenscheid, Germany, 58515
    • Klinikum Lüdenscheid, Märkische Gesundheitsholding GmbH & Co. KG
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Lübeck, Germany, 23538
    • UKSH Lübeck
  • Merseburg, Germany, 06217
    • Carl-von-Basedow-Klinik Saalekreis GmbH
  • München, Germany, 81675
    • Technische Universität München, Klinikum rechts der Isar
  • München, Germany, 81737
    • München Klinik gGmbH, Klinik Neuperlach
  • Münster, Germany, 48145
    • St. Franziskus-Hospital GmbH
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Kardiologie
  • Paderborn, Germany, 33098
    • St. Vincenz Krankenhaus
  • Quedlinburg, Germany, 06484
    • Harzklinikum Dorothea Christiane Erxleben GmbH
  • Rostock, Germany, 18057
    • Universitatsmedizin Rostock
  • Rotenburg An Der Fulda, Germany, 36119
    • Herz-Kreislauf-Zentrum Rotenburg
  • Schweinfurt, Germany, 97422
    • Leopoldina
  • Stadtlohn, Germany, 48703
    • Klinikum Westmünsterland GmbH
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus GmbH
  • Suhl, Germany, 98527
    • SRH Zentralklinikum Suhl, Innere Medizin I
  • Trier, Germany, 54292
    • Krankenhaus der Barmherzigen Brüder Trier
  • Tübingen, Germany, 72076
    • Universitatsklinikum Tubingen
  • Ulm, Germany, 89081
    • Universitatsklinikum Ulm
  • Volklingen, Germany, 66333
    • Herzzentrum Saar
  • Weiden, Germany, 92637
    • Kliniken Nordoberpfalz AG
  • Weinheim, Germany, 69469
    • GRN-Klinik Weinheim
  • Wilhelmshaven, Germany, 26389
    • Klinikum Wilhelmshaven gGmbH
  • Wuppertal, Germany, 42283
    • Petrus-Krankenhaus Wuppertal
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
  • Zwickau, Germany, 08060
    • Heinrich-Braun-Klinikum Zwickau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NVAF patients undergoing PCI; Patients with non-valvular atrial fibrillation (NVAF) who had successful percutaneous coronary intervention (PCI).	Drug: Edoxaban; This is an observational, prospective study; no treatment will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Collaborators: Daiichi Sankyo Deutschland GmbH
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): July 6, 2023
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Non-valvular atrial fibrillation; Antiplatelet therapy; Edoxaban; Anticoagulation therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: DS-EDO-01-20-DE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No