The Incidence of New-brain Lesions on Brain MRI and Safety Between Edoxaban and Apixaban in Patients with Stroke and Nonvalvular Atrial Fibrillation

NCT06864052 | Not Yet Recruiting

• 1 other identifier: SEUMC 2024-08-070
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether there is a difference in brain lesion occurrence and safety when brain MRI is followed up between edoxaban and apixaban in stroke patients with nonvalvular atrial fibrillation through exploratory clinical trials.

Conditions

Stroke; Atrial Fibrillation

Keywords

Non-Vitamin K Antagonist Oral Anticoagulants; Edoxaban; Apixaban

Outcome Measures

Primary Outcomes (1)

• Brain MR findings (Differences in the incidence of new brain lesions)

  Brain MR findings evaluated at 24 months after the first dose of clinical trial-related drugs (new cerebral infarction (including asymptomatic), white matter hyperintensity, microhemorrhage, etc.)

  24 months

Secondary Outcomes (4)

• Major cardio-cerebrovascular events

  12 and 24 months

• Modified Rankin scale

  12 and 24 months

• NIHSS (National Institute of Health Stroke Scale)

  12 and 24 months

• Other finding of brain MR (Differences in the incidence of new brain lesions)

  24 months

Study Arms (2)

Administration of Apixaban

EXPERIMENTAL

The intervention group will receive Apixaban 2.5mg or Apixaban 5mg

Drug: Administration of Apixaban

Administration of Edoxaban

OTHER

The control group will receive Edoxaban 15mg or 30mg or 60mg

Drug: Administration of Edoxaban

Interventions

Administration of Apixaban DRUG

Apixaban 2.5mg BID or Apixaban 5mg BID

Administration of Apixaban

Administration of Edoxaban DRUG

Edoxaban 15mg QD or Edoxaban 30mg QD or Edoxaban 60mg QD

Administration of Edoxaban

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 19 or over.
• Patients who are neurologically stable 14 days after diagnosis of ischemic stroke and who have undergone brain MRI (including MR diffusion, FLAIR, and GRE sequence) at diagnosis of ischemic stroke (In general, the patient's condition stabilizes within seven days of acute cerebral infarction, but cerebral infarction with atrial fibrillation is more frequent than patients without atrial fibrillation, so we want to target patients with neurological stability after 14 days. Most NOAC-related clinical trials were conducted when the patient's condition became neurologically stable at least two weeks after the stroke.)
• Patients with atrial fibrillation confirmed by 12-lead electrocardiogram or Holter's examination for more than 24 hours and nonvalvular atrial fibrillation
• A person who voluntarily agrees to participate in this clinical trial in writing

You may not qualify if:

• Patients unable or contraindicated to administer anticoagulants and antithrombotic agents
• Patients with less than 80,000 platelets, less than 8.0 hemoglobin, liver levels, and total bilirubin levels three times the normal level in the laboratory
• A person who is confirmed to be undergoing renal replacement treatment such as dialysis due to acute or terminal nephropathy during screening
• A person who has been diagnosed with cancer within 6 months at the time of screening or has been treated for cancer has been confirmed to have recurrent or metastatic cancer.
• A person who has been confirmed to be taking medication for liver diseases such as liver cirrhosis during screening
• A person who is pregnant and nursing. However, women of childbearing age can participate only if it is certain that they are not pregnant. Women of childbearing age are defined as women except those who have not clearly undergone menopause or are unable to conceive by surgical procedures.
• A patient with a history of hemorrhagic tendencies, gastrointestinal hemorrhage
• Patients who have difficulty explaining and expressing their opinions on participation in the study due to decreased consciousness at the time of acquisition of consent
• A person who judges that the tester is not appropriate for participation in the clinical trial for other reasons.

Sponsors & Collaborators

• Ewha Womans University Seoul Hospital: lead

Study Sites (1)

Ewha Womans University Medical Center

Seoul, Seoul, 07804, South Korea

Location

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sujin Han Clinical Research Coordinator

CONTACT

82-2-6986-2635; sujinhan1004@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cerebrovascular hospital, the director of a hospital

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)