Skip to main content
OpenTrials
Completed

NCT Number: NCT04519944

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-valvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zentralklinik Bad Berka, Bad Berka, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edoxaban

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Daiichi Sankyo Deutschland GmbH

Registry information

Official study title

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

Acronym: ENCOURAGE-AF

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2020
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.