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Apixaban and Clopidogrel for Stroke Prevention in Atrial Fibrillation and Atherosclerosis

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Study Aim

This study evaluates whether the combination of apixaban and clopidogrel can prevent stroke in people with atrial fibrillation and atherosclerosis by monitoring for new ischemic brain lesions.

What is being tested

Apixaban

+ Clopidogrel

Drug
Who is being recruted

Arrhythmias, Cardiac+12

+ Arterial Occlusive Diseases

+ Arteriosclerosis

Over 19 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorYonsei University
Study ContactYoung Dae Kim, M.D. Ph.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2025

Actual date on which the first participant was enrolled.

This study aims to find the best way to prevent further strokes in people who have both non-valvular atrial fibrillation (NVAF) and atherosclerosis of the brain's blood vessels. NVAF can cause strokes, and atherosclerosis, which is a narrowing of the arteries, adds to the risk. The study focuses on whether using the blood thinner apixaban alone or combined with another drug, clopidogrel, is more effective in preventing strokes in these patients. The results could help establish a more effective treatment plan for those at risk of recurrent strokes due to these combined conditions. Participants in the study will be randomly assigned to receive either apixaban alone or apixaban with clopidogrel for the first 30 days, followed by apixaban alone. The effectiveness of these treatments will be evaluated using MRI scans of the brain to check for new or returning stroke signs after 30 days. Additionally, the study will monitor for any stroke symptoms, heart-related issues, or deaths over a 90-day period. Safety is also a concern, so the study will track any major bleeding events or new brain bleeds that don't show symptoms. All findings will be reviewed by independent experts to ensure accuracy and reliability.

Official TitleA Multicenter Prospective Randomized Study to Evaluate the Efficacy of Apixaban and Clopidogrel on the Prevention of Recurrent Ischemic Stroke in Patients With Atrial Fibrillation and Cerebral Atherosclerosis
Principal SponsorYonsei University
Study ContactYoung Dae Kim, M.D. Ph.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

586 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacArterial Occlusive DiseasesArteriosclerosisAtrial FibrillationBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersHeart DiseasesIschemiaNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesStroke

Criteria

5 inclusion criteria required to participate
Adults aged 19 years or older at the time of enrollment.

Patients with non-valvular atrial fibrillation (NVAF) documented by electrocardiography or medical records.

Acute ischemic stroke confirmed by brain MRI (diffusion-weighted and FLAIR sequences), with neurological symptoms occurring within 5 days prior to randomization.

Presence of clinically significant atherosclerosis in the cerebral or aortic arteries, meeting at least one of the following criteria: ① ≥30% stenosis in the relevant artery (the artery supplying the infarcted territory) demonstrated by CTA, MRA, or DSA - using the WASID criteria for intracranial arteries and NASCET criteria for extracranial arteries. ② High-risk atherosclerotic plaque features in the relevant artery demonstrated by CTA, MRA, or ultrasound, such as ulceration, intraplaque hemorrhage, mobile plaque, or a large lipid core (involving ≥25% of plaque cross-sectional area) on CTA/MRA, or ulceration, mobile plaque, or hypoechoic/echolucent plaque on ultrasound; or presence of branch artery occlusive disease (BAOD). ③ Complex aortic plaque (≥4 mm in thickness, mobile, or ulcerative) identified in the ascending aorta or aortic arch by transthoracic/transesophageal echocardiography or coronary CT angiography.

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22 exclusion criteria prevent from participating
Presence of mechanical heart valves or rheumatic mitral stenosis.

Requirement for antiplatelet agents other than clopidogrel.

Planned percutaneous coronary intervention, coronary artery bypass graft surgery, carotid endarterectomy, or intracranial stenting within 3 months after enrollment.

Presence of mural thrombus in the heart confirmed by imaging.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants receive apixaban (5 mg or 2.5 mg if indicated) plus clopidogrel 75 mg daily for 30 days, followed by apixaban monotherapy thereafter.

Group II

Experimental
Participants receive apixaban 5 mg (or 2.5 mg if indicated) once daily as monotherapy for 30 days and continue apixaban monotherapy thereafter.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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