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Non-valvular Atrial FibrillationENCOURAGE-AFNCT04519944

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

An observational study of Non-valvular Atrial Fibrillation, run by Daiichi Sankyo at 66 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-valvular Atrial Fibrillation
What is being tested?
Edoxaban
How many people
666 participants
Where
66 sitesGermany
Study dates
30 Jun 2020to 6 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • ≥ 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)
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  • 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

Who cannot join

  • Not applicable

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

Germany66 sites

  • Zentralklinik Bad Berka

    Bad Berka, 99437

  • SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald

    Bad Friedrichshall, 74177

  • Kerckhoff-Klinik GmbH

    Bad Nauheim, 61231

  • Herz- und Diabeteszentrum Nordrhein-Westfalen

    Bad Oeynhausen, 32545

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

    Bad Rothenfelde, 49214

  • Charité - Campus Mitte

    Berlin, 10117

  • Charité - Campus Benjamin Franklin

    Berlin, 12203

  • Deutsches Herzzentrum Berlin

    Berlin, 13353

  • GFO-Kliniken, Standort St.-Marienhospital Bonn

    Bonn, 53115

  • StädtischesKlinikum Brandenburg

    Brandenburg, 14770

  • Klinikum Braunschweig

    Braunschweig, 38126

  • Klinikum Chemnitz

    Chemnitz, 09113

  • REGIOMED-KLINIKEN GmbH, Klinikum Coburg

    Coburg, 96450

  • Krankenhaus der Augustinerinnen Köln

    Cologne, 50678

  • St. Vinzenz-Hospital Köln

    Cologne, 50733

  • Universitätsklinikum Köln

    Cologne, 50937

  • Evangelisches Krankenhaus Kalk gGmbH

    Cologne, 51103

  • Kreiskrankenhaus Demmin GmbH

    Demmin, 17109

  • Klinikum Lippe Detmold

    Detmold, 32756

  • St. Johannes-Hospital Dortmund

    Dortmund, 44137

  • Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden

    Dresden, 01307

  • Krankenhaus Eggenfelden

    Eggenfelden, 84307

  • Universitätsklinikum Essen

    Essen, 45122

  • CCB Cardioangiologisches Centrum Bethanien

    Frankfurt, 60389

  • Klinikum Frankfurt Höchst GmbH

    Frankfurt am Main, 65929

  • Universitäts Herzzentrum Freiburg Bad Krozingen

    Freiburg im Breisgau, 79106

  • Klinikum Fürth

    Fürth, 90766

  • SRH Wald-Klinikum Gera

    Gera, 07548

  • Universitätsklinikum Greifswald

    Greifswald, 17475

  • Klinikum Gütersloh

    Gütersloh, 33332

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Asklepios Kliniken Hamburg GmbH - Aklepios Klinik Barmbek

    Hamburg, 22307

  • Asklepios Klinikum Harburg

    Harburg, 21075

  • SLK-Kliniken Heilbronn

    Heilbronn, 74708

  • Klinikum Nordfriesland

    Husum, 25813

  • Universitätsklinikum Jena

    Jena, 07740

  • SRH Klinikum Karlsbad-Langensteinbach GmbH

    Karlsbad, 76307

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105

  • Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin

    Koblenz, 56068

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • UKSH Lübeck

    Lübeck, 23538

  • Klinikum Lüdenscheid, Märkische Gesundheitsholding GmbH & Co. KG

    Lüdenscheid, 58515

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • Carl-von-Basedow-Klinik Saalekreis GmbH

    Merseburg, 06217

  • Technische Universität München, Klinikum rechts der Isar

    München, 81675

  • München Klinik gGmbH, Klinik Neuperlach

    München, 81737

  • St. Franziskus-Hospital GmbH

    Münster, 48145

  • Klinikum Oldenburg AöR, Universitätsklinik für Innere Medizin - Kardiologie

    Oldenburg, 26133

  • St. Vincenz Krankenhaus

    Paderborn, 33098

  • Harzklinikum Dorothea Christiane Erxleben GmbH

    Quedlinburg, 06484

  • Universitätsmedizin Rostock

    Rostock, 18057

  • Herz-Kreislauf-Zentrum Rotenburg

    Rotenburg an der Fulda, 36119

  • Leopoldina

    Schweinfurt, 97422

  • Klinikum Westmünsterland GmbH

    Stadtlohn, 48703

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart, 70376

  • SRH Zentralklinikum Suhl, Innere Medizin I

    Suhl, 98527

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Herzzentrum Saar

    Völklingen, 66333

  • Kliniken Nordoberpfalz AG

    Weiden, 92637

  • GRN-Klinik Weinheim

    Weinheim, 69469

  • Klinikum Wilhelmshaven gGmbH

    Wilhelmshaven, 26389

  • Petrus-Krankenhaus Wuppertal

    Wuppertal, 42283

  • Universitätsklinikum Würzburg

    Würzburg, 97080

  • Heinrich-Braun-Klinikum Zwickau

    Zwickau, 08060

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Edoxaban
Keywords
Non-valvular atrial fibrillation, Antiplatelet therapy, Anticoagulation therapy, Percutaneous coronary intervention, Edoxaban

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EdoxabanDrug

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

Study groups in NCT04519944
Study groupRoleWhat they receive
NVAF patients undergoing PCIPatients with non-valvular atrial fibrillation (NVAF) who had successful percutaneous coronary intervention (PCI).
Receives: Drug: Edoxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Usage of Peri- and Post-procedural Anticoagulation and Antiplatelet Therapy in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

    Measured: Up to 1 year follow up after PCI

Secondary outcomes (4)

  1. 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.

    Measured: Up to 1 year follow up after PCI

  2. EQ-5D-5L Assessment in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

    Measured: Up to 1 year follow up after PCI

  3. Number of Hospital Admissions in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

    Measured: Up to 1 year follow up after PCI

  4. Duration of Hospital Admission in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

    Measured: Up to 1 year follow up after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start30 Jun 2020
  3. Primary completion6 Jul 2023
  4. Study completion6 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04519944
Sponsor's protocol ID
DS-EDO-01-20-DE
Acronym
ENCOURAGE-AF
Status last verified
Jul 2023
First submitted
17 Aug 2020
Last updated
2 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 37880316

Questions about this trial

What is this clinical trial studying?

An observational study of Non-valvular Atrial Fibrillation, run by Daiichi Sankyo at 66 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usage of Peri- and Post-procedural Anticoagulation and Antiplatelet Therapy in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (time frame: Up to 1 year follow up after PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04519944, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.

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