Low Dose Edoxaban in Elderly Patients With AF and a History of Stroke

NCT06900725 | Not Yet Recruiting Phase 2

• 1 other identifier: 202501081MINB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This prospectively enrolled, pragmatic randomized trial aims to investigate whether very low dose edoxaban regimen (15 mg daily) achieves similar edoxaban concentrations as low dose edoxaban regimen (30 mg daily), while maintaining a comparable risk of clinical outcomes and reducing major bleeding in elderly patients with atrial fibrillation and a history of ischemic stroke or transient ischemic attack.

Conditions

Elderly; Atrial Fibrillation (AF); Ischemic Stroke

Keywords

very low-dose edoxaban; elderly; drug concentration; major bleeding; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• The proportion of patients achieving edoxaban concentrations within the expected range

  The proportion of patients achieving edoxaban concentrations within the expected range from the ENGAGE-AF TIMI 48 trial (12-43 ng/mL at trough) at 1 month.

  1 month

Secondary Outcomes (2)

• Major bleeding

  3 months

• Composite outcome

  3 months

Study Arms (2)

LDER

EXPERIMENTAL

Patients will receive edoxaban 30 mg daily for stroke prevention.

Drug: Edoxaban 30 mg

VLDER

ACTIVE COMPARATOR

Patients will receive edoxaban 15 mg daily for stroke prevention.

Drug: edoxaban

Interventions

edoxaban DRUG

edoxaban 15 mg daily will be administered to the patients as secondary stroke prevention.

Also known as: VLDER

VLDER

Edoxaban 30 mg DRUG

edoxaban 30 mg daily will be administered to the patients as secondary stroke prevention.

Also known as: LDER

LDER

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age\>=80 years
• Has been diagnosed atrial fibrillation
• Has history of ischemic stroke or transient ischemic attack
• Has any of the bleeding risk lists below
• bodyweight \< 60 kg
• creatinine clearance \< 50 mL/min
• history of major bleeding or gastrointestinal bleeding
• concurrent use of antiplatelet agents (such as aspirin, clopidogrel, ticagrelor, prasugrel, cilostazol), non-steroidal anti-inflammatory drugs, amiodarone, tacrolimus, cyclosporine, dronedarone.

You may not qualify if:

• Has ever used anticoagulants, defined as:
• warfarin therapy within 1 month before study enrollment.
• using heparin, low molecular weight heparin or direct oral anticoagulants within 7 days before study enrollment.
• allergy to edoxaban
• under regular dialysis, includes hemodialysis or peritoneal dialysis
• refuse to provide informed consent.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator
• National Taiwan University Hospital Hsin-Chu Branch: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Central Study Contacts

Shin Yi Lin, MS

CONTACT

886223123456; shinyi924@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)