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

NCT04519944 | Completed FDA Drug

• 1 other identifier: DS-EDO-01-20-DE
• Study Type: observational
• Target: 666
• Locations: 1 country
• Sites: 66

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.

Conditions

Non-valvular Atrial Fibrillation

Keywords

Non-valvular atrial fibrillation; Antiplatelet therapy; Anticoagulation therapy; Percutaneous coronary intervention; Edoxaban

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

Study Arms (1)

NVAF patients undergoing PCI

Patients with non-valvular atrial fibrillation (NVAF) who had successful percutaneous coronary intervention (PCI).

Drug: Edoxaban

Interventions

Edoxaban DRUG

This is an observational, prospective study; no treatment will be administered.

NVAF patients undergoing PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• ≥ 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Daiichi Sankyo Deutschland GmbH: collaborator

Study Sites (66)

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald

Bad Friedrichshall, 74177, Germany

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, 32545, Germany

Location

Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG

Bad Rothenfelde, 49214, Germany

Location

Charité - Campus Mitte

Berlin, 10117, Germany

Location

Charité - Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

GFO-Kliniken, Standort St.-Marienhospital Bonn

Bonn, 53115, Germany

Location

StädtischesKlinikum Brandenburg

Brandenburg, 14770, Germany

Location

Klinikum Braunschweig

Braunschweig, 38126, Germany

Location

Klinikum Chemnitz

Chemnitz, 09113, Germany

Location

REGIOMED-KLINIKEN GmbH, Klinikum Coburg

Coburg, 96450, Germany

Location

Krankenhaus der Augustinerinnen Köln

Cologne, 50678, Germany

Location

St. Vinzenz-Hospital Köln

Cologne, 50733, Germany

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Evangelisches Krankenhaus Kalk gGmbH

Cologne, 51103, Germany

Location

Kreiskrankenhaus Demmin GmbH

Demmin, 17109, Germany

Location

Klinikum Lippe Detmold

Detmold, 32756, Germany

Location

St. Johannes-Hospital Dortmund

Dortmund, 44137, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Krankenhaus Eggenfelden

Eggenfelden, 84307, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

CCB Cardioangiologisches Centrum Bethanien

Frankfurt, 60389, Germany

Location

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, 65929, Germany

Location

Universitäts Herzzentrum Freiburg Bad Krozingen

Freiburg im Breisgau, 79106, Germany

Location

Klinikum Fürth

Fürth, 90766, Germany

Location

SRH Wald-Klinikum Gera

Gera, 07548, Germany

Location

Universitätsklinikum Greifswald

Greifswald, 17475, Germany

Location

Klinikum Gütersloh

Gütersloh, 33332, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Asklepios Kliniken Hamburg GmbH - Aklepios Klinik Barmbek

Hamburg, 22307, Germany

Location

Asklepios Klinikum Harburg

Harburg, 21075, Germany

Location

SLK-Kliniken Heilbronn

Heilbronn, 74708, Germany

Location

Klinikum Nordfriesland

Husum, 25813, Germany

Location

Universitätsklinikum Jena

Jena, 07740, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad, 76307, Germany

Location

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105, Germany

Location

Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin

Koblenz, 56068, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, 67063, Germany

Location

UKSH Lübeck

Lübeck, 23538, Germany

Location

Klinikum Lüdenscheid, Märkische Gesundheitsholding GmbH & Co. KG

Lüdenscheid, 58515, Germany

Location

Carl-von-Basedow-Klinik Saalekreis GmbH

Merseburg, 06217, Germany

Location

Technische Universität München, Klinikum rechts der Isar

München, 81675, Germany

Location

München Klinik gGmbH, Klinik Neuperlach

München, 81737, Germany

Location

St. Franziskus-Hospital GmbH

Münster, 48145, Germany

Location

Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Kardiologie

Oldenburg, 26133, Germany

Location

St. Vincenz Krankenhaus

Paderborn, 33098, Germany

Location

Harzklinikum Dorothea Christiane Erxleben GmbH

Quedlinburg, 06484, Germany

Location

Universitätsmedizin Rostock

Rostock, 18057, Germany

Location

Herz-Kreislauf-Zentrum Rotenburg

Rotenburg an der Fulda, 36119, Germany

Location

Leopoldina

Schweinfurt, 97422, Germany

Location

Klinikum Westmünsterland GmbH

Stadtlohn, 48703, Germany

Location

Robert-Bosch-Krankenhaus GmbH

Stuttgart, 70376, Germany

Location

SRH Zentralklinikum Suhl, Innere Medizin I

Suhl, 98527, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, 54292, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Herzzentrum Saar

Völklingen, 66333, Germany

Location

Kliniken Nordoberpfalz AG

Weiden, 92637, Germany

Location

GRN-Klinik Weinheim

Weinheim, 69469, Germany

Location

Klinikum Wilhelmshaven gGmbH

Wilhelmshaven, 26389, Germany

Location

Petrus-Krankenhaus Wuppertal

Wuppertal, 42283, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Heinrich-Braun-Klinikum Zwickau

Zwickau, 08060, Germany

Location

Related Publications (1)

• Baldus S, Beyer-Westendorf J, Mollmann H, Rottbauer W, Beyerlein E, Goette A. Edoxaban in patients with non-valvular atrial fibrillation after percutaneous coronary intervention: ENCOURAGE-AF design. Sci Rep. 2023 Oct 25;13(1):18215. doi: 10.1038/s41598-023-44345-7.

  PMID: 37880316 DERIVED

MeSH Terms

Interventions

edoxaban

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: June 30, 2020
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

DE (66)