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

Completed

• Conditions: Non-valvular Atrial Fibrillation
• Interventions: Drug: Edoxaban

• Registration Number: NCT04519944
• Lead Sponsor: Daiichi Sankyo

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.

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 Timeline

• Study Start: 2020-06-30
• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Status Verified: 2023-07
• Primary Completion: 2023-07-06
• Study Completion: 2023-07-06
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 666

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NVAF patients undergoing PCI	Edoxaban	Patients with non-valvular atrial fibrillation (NVAF) who had successful percutaneous coronary intervention (PCI).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Bleeding (major, minor, CRNM), stroke, myocardial infarction (MI), percutaneous coronary intervention (PCI), and death will be assessed.
EQ-5D-5L Assessment 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
Number of Hospital Admissions in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention	Up to 1 year follow up after PCI

Trial Locations

Locations (66)

Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Germany

SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald; 🇩🇪 Bad Friedrichshall, Germany

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Germany

Herz- und Diabeteszentrum Nordrhein-Westfalen; 🇩🇪 Bad Oeynhausen, Germany

Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG; 🇩🇪 Bad Rothenfelde, Germany

Charité - Campus Mitte; 🇩🇪 Berlin, Germany

Charité - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

GFO-Kliniken, Standort St.-Marienhospital Bonn; 🇩🇪 Bonn, Germany

StädtischesKlinikum Brandenburg; 🇩🇪 Brandenburg, Germany

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