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Blood Thinner's safety in frail hearts put to the test

NCT ID NCT05773222

Disease control Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This observational study is evaluating the safety and effectiveness of apixaban, a blood thinner, in frail Korean patients with atrial fibrillation (an irregular heartbeat) who are at high risk for stroke and bleeding. The study will follow about 2,000 patients who are older, have low body weight, or have reduced kidney function, to see how well apixaban prevents strokes and blood clots without causing major bleeding. By observing real-world use, researchers hope to fill a gap in knowledge about this medication in a high-risk Asian population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apixaban
What this could lead to
If successful, this study could provide reassurance that apixaban is a safe and effective option for stroke prevention in frail, high-risk patients with atrial fibrillation, potentially guiding treatment decisions in this vulnerable population.
What could go wrong
As an observational study, it cannot prove cause and effect, and results may be influenced by confounding factors. The findings may not generalize beyond the specific Korean population studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,002 people

The number who actually took part.

Started

Aug 2019

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A. Arm Label: prospective, multicenter, non-interventional observational study B. Arm type: no intervention

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient must be ≥19 years. 2. Patient has non-valvular atrial fibrillation necessitating the use of apixaban for stroke prevention. 3. Subjects satisfies single dose reduction criterion for apixaban; (1) age 80 years or older (2) body weight 60kg or lower (3) serum creatinine 1.5mg/dL or higher. Exclusion Criteria: 1. Patient is vulnerable (according to Korean Good Clinical Practice definition) or disagree with the study. 2. Patient had a history of clinical events, defined as primary and secondary outcomes of the study, prior to study registration after taking apixaban. 3. Patient satisfies two or more dose reduction criteria for apixaban.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

Contacts and locations

Locations

  • Seoul National university Hostpital

    Seoul, Jongno-gu, 03080, South Korea

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