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

NCT ID: NCT04519944

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

666 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2023-07-06

Brief Summary

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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

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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.

Conditions

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Non-valvular Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NVAF patients undergoing PCI

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

Edoxaban

Intervention Type DRUG

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

Interventions

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Edoxaban

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Deutschland GmbH

UNKNOWN

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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Zentralklinik Bad Berka

Bad Berka, , Germany

Site Status

SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald

Bad Friedrichshall, , Germany

Site Status

Kerckhoff-Klinik GmbH

Bad Nauheim, , Germany

Site Status

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, , Germany

Site Status

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

Bad Rothenfelde, , Germany

Site Status

Charité - Campus Mitte

Berlin, , Germany

Site Status

Charité - Campus Benjamin Franklin

Berlin, , Germany

Site Status

Deutsches Herzzentrum Berlin

Berlin, , Germany

Site Status

GFO-Kliniken, Standort St.-Marienhospital Bonn

Bonn, , Germany

Site Status

StädtischesKlinikum Brandenburg

Brandenburg, , Germany

Site Status

Klinikum Braunschweig

Braunschweig, , Germany

Site Status

Klinikum Chemnitz

Chemnitz, , Germany

Site Status

REGIOMED-KLINIKEN GmbH, Klinikum Coburg

Coburg, , Germany

Site Status

Krankenhaus der Augustinerinnen Köln

Cologne, , Germany

Site Status

St. Vinzenz-Hospital Köln

Cologne, , Germany

Site Status

Universitätsklinikum Köln

Cologne, , Germany

Site Status

Evangelisches Krankenhaus Kalk gGmbH

Cologne, , Germany

Site Status

Kreiskrankenhaus Demmin GmbH

Demmin, , Germany

Site Status

Klinikum Lippe Detmold

Detmold, , Germany

Site Status

St. Johannes-Hospital Dortmund

Dortmund, , Germany

Site Status

Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden

Dresden, , Germany

Site Status

Krankenhaus Eggenfelden

Eggenfelden, , Germany

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

CCB Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

Site Status

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, , Germany

Site Status

Universitäts Herzzentrum Freiburg Bad Krozingen

Freiburg im Breisgau, , Germany

Site Status

Klinikum Fürth

Fürth, , Germany

Site Status

SRH Wald-Klinikum Gera

Gera, , Germany

Site Status

Universitätsklinikum Greifswald

Greifswald, , Germany

Site Status

Klinikum Gütersloh

Gütersloh, , Germany

Site Status

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status

Asklepios Kliniken Hamburg GmbH - Aklepios Klinik Barmbek

Hamburg, , Germany

Site Status

Asklepios Klinikum Harburg

Harburg, , Germany

Site Status

SLK-Kliniken Heilbronn

Heilbronn, , Germany

Site Status

Klinikum Nordfriesland

Husum, , Germany

Site Status

Universitätsklinikum Jena

Jena, , Germany

Site Status

SRH Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, , Germany

Site Status

Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin

Koblenz, , Germany

Site Status

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, , Germany

Site Status

UKSH Lübeck

Lübeck, , Germany

Site Status

Klinikum Lüdenscheid, Märkische Gesundheitsholding GmbH & Co. KG

Lüdenscheid, , Germany

Site Status

Carl-von-Basedow-Klinik Saalekreis GmbH

Merseburg, , Germany

Site Status

Technische Universität München, Klinikum rechts der Isar

München, , Germany

Site Status

München Klinik gGmbH, Klinik Neuperlach

München, , Germany

Site Status

St. Franziskus-Hospital GmbH

Münster, , Germany

Site Status

Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Kardiologie

Oldenburg, , Germany

Site Status

St. Vincenz Krankenhaus

Paderborn, , Germany

Site Status

Harzklinikum Dorothea Christiane Erxleben GmbH

Quedlinburg, , Germany

Site Status

Universitätsmedizin Rostock

Rostock, , Germany

Site Status

Herz-Kreislauf-Zentrum Rotenburg

Rotenburg an der Fulda, , Germany

Site Status

Leopoldina

Schweinfurt, , Germany

Site Status

Klinikum Westmünsterland GmbH

Stadtlohn, , Germany

Site Status

Robert-Bosch-Krankenhaus GmbH

Stuttgart, , Germany

Site Status

SRH Zentralklinikum Suhl, Innere Medizin I

Suhl, , Germany

Site Status

Krankenhaus der Barmherzigen Brüder Trier

Trier, , Germany

Site Status

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status

Universitätsklinikum Ulm

Ulm, , Germany

Site Status

Herzzentrum Saar

Völklingen, , Germany

Site Status

Kliniken Nordoberpfalz AG

Weiden, , Germany

Site Status

GRN-Klinik Weinheim

Weinheim, , Germany

Site Status

Klinikum Wilhelmshaven gGmbH

Wilhelmshaven, , Germany

Site Status

Petrus-Krankenhaus Wuppertal

Wuppertal, , Germany

Site Status

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status

Heinrich-Braun-Klinikum Zwickau

Zwickau, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 37880316 (View on PubMed)

Other Identifiers

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DS-EDO-01-20-DE

Identifier Type: -

Identifier Source: org_study_id

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