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

July 31, 2023 updated by: Daiichi Sankyo, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
666

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Charite - 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
        • Universitätsklinikum 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
        • Universitätsklinikum 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
        • Universitätsklinikum 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
        • Universitätsklinikum Würzburg
      • Zwickau, Germany, 08060
        • Heinrich-Braun-Klinikum Zwickau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Up to 1 year follow up after PCI
Up to 1 year follow up after PCI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Up to 1 year follow up after PCI
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
Time Frame: Up to 1 year follow up after PCI
Up to 1 year follow up after PCI
Number of Hospital Admissions in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
Time Frame: Up to 1 year follow up after PCI
Up to 1 year follow up after PCI
Duration of Hospital Admission in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
Time Frame: Up to 1 year follow up after PCI
Up to 1 year follow up after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Daiichi Sankyo Deutschland GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-valvular Atrial Fibrillation

Clinical Trials on Edoxaban

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings