ElderlyPhase 2/3LEAVE-StrokeNCT06900725
Low Dose Edoxaban in Elderly Patients With AF and a History of Stroke
A Phase 2/3 study testing edoxaban and Edoxaban 30 mg in people with Elderly and Atrial Fibrillation (AF), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Elderly, Atrial Fibrillation (AF), Ischemic Stroke
- What is being tested?
- edoxaban and Edoxaban 30 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2025to 31 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Shin Yi Lin, 0223123456, hsin924@ntuh.gov.tw
About this study
Official title: Low-Dose Edoxaban Versus Very-Low-Dose Edoxaban in Elderly Patients With Atrial Fibrillation and a History of Stroke (LEAVE-Stroke): A Pragmatic Randomized Clinical Trial
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.
Read the detailed description
Edoxaban, a factor Xa inhibitor, is used to prevent stroke or systemic thromboembolism (SSE) in patients with atrial fibrillation (AF). In elderly patients, the post-hoc analysis of the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial showed that a low-dose edoxaban regimen (LDER, 30 mg daily) reduced the risk of major bleeding compared to the standard-dose edoxaban regimen (SDER, 60 mg daily), without an offsetting increase in SSE risk. Furthermore, the Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients (ELDERCARE AF) trial demonstrated that a very-low-dose edoxaban regimen (VLDER, 15 mg daily) was more effective than placebo for elderly patients where standard anticoagulant intensity posed safety concerns. Although both LDER and VLDER appear suitable for the elderly population, data comparing these two regimens are lacking.
Specific purpose:
To investigate whether VLDER (15 mg daily) achieves similar edoxaban concentrations as LDER (30 mg daily), while maintaining a comparable risk of clinical outcomes and reducing major bleeding in elderly patients with AF and a history of ischemic stroke (IS) or transient ischemic attack (TIA) through a pragmatic randomized trial.
Study design:
The Very Low-Dose Edoxaban in Elderly Atrial Fibrillation Patients with a History of Stroke (LEAVE-Stroke) trial is a prospective, multicenter, randomized trial. Elderly patients aged ≥ 80 years with AF, a history of IS/TIA and concerns about the bleeding risk of standard anticoagulant intensity will be enrolled. Participants will be randomized to either the VLDER or LDER group.
Participant number: 120 patients (60 patients in each group). YEAR 1: Participant enrollment for the LEAVE-Stroke trial. YEAR 2: Continued participant enrollment, followed by a comparison of edoxaban concentration and clinical outcomes between two dose groups.
Study outcomes:
Primary outcome: 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.
Secondary outcome: Major bleeding at 3 months, a composite of major bleeding, SSE or death at 3 months.
Significance: This pragmatic randomized trial will be the first to report real-world edoxaban concentrations in the VLDER group and to determine whether they are comparable to those in the LDER group. Furthermore, the study will provide insights into the short-term outcomes of VLDER in elderly patients with AF, a history of IS/TIA, and concerns about increased bleeding risk. These findings will not only inform edoxaban dosing strategies in clinical practice but also serve as a foundation for future large-scale, long-term studies to evaluate the feasibility and safety of using VLDER in this high-risk population.
Keywords: very low-dose edoxaban, elderly, drug concentration, major bleeding, atrial fibrillation
- Conditions
- Elderly, Atrial Fibrillation (AF), Ischemic Stroke
- Being tested
- edoxaban, Edoxaban 30 mg
- Keywords
- very low-dose edoxaban, elderly, drug concentration, major bleeding, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edoxabanDrug
Also called VLDER
edoxaban 15 mg daily will be administered to the patients as secondary stroke prevention.
Edoxaban 30 mgDrug
Also called LDER
edoxaban 30 mg daily will be administered to the patients as secondary stroke prevention.
| Study group | Role | What they receive |
|---|---|---|
| LDER | Experimental | Patients will receive edoxaban 30 mg daily for stroke prevention. Receives: Drug: Edoxaban 30 mg |
| VLDER | Active comparator | Patients will receive edoxaban 15 mg daily for stroke prevention. Receives: Drug: edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
Major bleeding
Major bleeding at 3 months
Major bleeding is classified according to the Platelet Inhibition and Patient Outcomes (PLATO) criteria. Major life-threatening bleeding was defined as intracranial hemorrhage, intrapericardial bleeding, or overt bleeding leading to hemorrhagic shock, hypotension requiring inotropic agents or surgical intervention, or a hemoglobin reduction of more than 5 g/dL or necessitating a transfusion of ≥4 units of packed red blood cells. Other major bleeding events were classified as significant, disabling bleeding, or bleeding resulting in a hemoglobin decrease of 3-5 g/dL requiring a transfusion of 2-3 units of packed red blood cells.
Measured: 3 months
Composite outcome
A composite of major bleeding, stroke or systemic thromboembolism or death.
Stroke or systemic thromboembolism includes ischemic stroke (IS), transient ischemic attack (TIA), acute coronary syndrome, coronary artery disease, peripheral arterial occlusive disease, and venous thromboembolism.
IS or TIA diagnoses were confirmed by brain computed tomography (CT) or magnetic resonance imaging (MRI). Brain CT angiography or perfusion was performed in patients with suspected large vessel occlusion. TIA was defined as a transient or reversible episode of neurological dysfunction lasting for < 24 h
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University Hospital Hsin-Chu Branch
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900725
- Sponsor's protocol ID
- 202501081MINB
- Acronym
- LEAVE-Stroke
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Edoxaban Versus Very-Low-Dose Edoxaban in Elderly Patients With Atrial Fibrillation and a History of Stroke (LEAVE-Stroke): A Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06900725
- Acronym / sponsor ID
- LEAVE-Stroke / 202501081MINB
- Conditions
- Elderly, Atrial Fibrillation (AF), Ischemic Stroke
- Keywords
- very low-dose edoxaban, elderly, drug concentration, major bleeding, atrial fibrillation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University Hospital Hsin-Chu Branch
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Edoxaban, a factor Xa inhibitor, is used to prevent stroke or systemic thromboembolism (SSE) in patients with atrial fibrillation (AF). In elderly patients, the post-hoc analysis of the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial showed that a low-dose edoxaban regimen (LDER, 30 mg daily) reduced the risk of major bleeding compared to the standard-dose edoxaban regimen (SDER, 60 mg daily), without an offsetting increase in SSE risk. Furthermore, the Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients (ELDERCARE AF) trial demonstrated that a very-low-dose edoxaban regimen (VLDER, 15 mg daily) was more effective than placebo for elderly patients where standard anticoagulant intensity posed safety concerns. Although both LDER and VLDER appear suitable for the elderly population, data comparing these two regimens are lacking.
Specific purpose:
To investigate whether VLDER (15 mg daily) achieves similar edoxaban concentrations as LDER (30 mg daily), while maintaining a comparable risk of clinical outcomes and reducing major bleeding in elderly patients with AF and a history of ischemic stroke (IS) or transient ischemic attack (TIA) through a pragmatic randomized trial.
Study design:
The Very Low-Dose Edoxaban in Elderly Atrial Fibrillation Patients with a History of Stroke (LEAVE-Stroke) trial is a prospective, multicenter, randomized trial. Elderly patients aged ≥ 80 years with AF, a history of IS/TIA and concerns about the bleeding risk of standard anticoagulant intensity will be enrolled. Participants will be randomized to either the VLDER or LDER group.
Participant number: 120 patients (60 patients in each group). YEAR 1: Participant enrollment for the LEAVE-Stroke trial. YEAR 2: Continued participant enrollment, followed by a comparison of edoxaban concentration and clinical outcomes between two dose groups.
Study outcomes:
Primary outcome: 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.
Secondary outcome: Major bleeding at 3 months, a composite of major bleeding, SSE or death at 3 months.
Significance: This pragmatic randomized trial will be the first to report real-world edoxaban concentrations in the VLDER group and to determine whether they are comparable to those in the LDER group. Furthermore, the study will provide insights into the short-term outcomes of VLDER in elderly patients with AF, a history of IS/TIA, and concerns about increased bleeding risk. These findings will not only inform edoxaban dosing strategies in clinical practice but also serve as a foundation for future large-scale, long-term studies to evaluate the feasibility and safety of using VLDER in this high-risk population.
Keywords: very low-dose edoxaban, elderly, drug concentration, major bleeding, atrial fibrillation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDER | Experimental | Drug: Edoxaban 30 mgPatients will receive edoxaban 30 mg daily for stroke prevention. |
| VLDER | Active comparator | Drug: edoxabanPatients will receive edoxaban 15 mg daily for stroke prevention. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| edoxabanAlso: VLDERedoxaban 15 mg daily will be administered to the patients as secondary stroke prevention. | Drug | VLDER |
| Edoxaban 30 mgAlso: LDERedoxaban 30 mg daily will be administered to the patients as secondary stroke prevention. | Drug | LDER |
Primary outcome
The proportion of patients achieving edoxaban concentrations within the expected range
Time frame: 1 month
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.
2 secondary outcomes
Major bleeding
Time frame: 3 months
Composite outcome
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing edoxaban and Edoxaban 30 mg in people with Elderly and Atrial Fibrillation (AF), run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shin Yi Lin, MS (886223123456, shinyi924@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving edoxaban concentrations within the expected range (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2025.