Blood thinners may prevent strokes in Moderate-Risk AF patients, trial investigates
NCT ID NCT04437654
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This study tests whether direct oral anticoagulants (DOACs) like apixaban or rivaroxaban reduce the risk of stroke, major bleeding, or heart-related death in people with atrial fibrillation who have an intermediate stroke risk (CHA2DS2-VASc score of 1 in men or 2 in women). About 1,800 participants in South Korea are randomly assigned to receive a DOAC or no anticoagulant for two years. The goal is to see if the benefits of blood thinning outweigh the risks in this moderate-risk group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- apixaban or rivaroxaban (blood thinners)
- What this could lead to
- If it works, this could clarify whether blood thinners benefit people with atrial fibrillation who have a moderate stroke risk, potentially preventing strokes without causing excessive bleeding.
- What could go wrong
- This is a Phase 4 trial, so the drugs are already approved, but the benefit in this specific intermediate-risk group is unproven. There is a risk of major bleeding, and the open-label design may introduce bias.
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.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
1,803 people
The number who actually took part.
- Started
-
Jul 2020
- Finished
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Aug 2025
- 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.
- Ages
-
19 to 80 years
- 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 Hide 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 with atrial fibrillation aged between 19 and 80 years 2. CHA2DS2-VASc score of 1 (male) or 2 (female) Exclusion Criteria 1. Significant liver (aspartate transaminase and/or alanine transaminase \> 3 times the upper limit of normal or liver cirrhosis classified as Child-Pugh class B or C) or renal disease (serum creatinine ≥ 3.5 mg/dl or creatinine clearance \< 30 ml/min) 2. Requiring anticoagulation due to surgery with a mechanical prosthetic valve, moderate-to-severe mitral stenosis, or deep vein thrombosis 3. Significant structural heart disease A. Moderate mitral regurgitation B. Severe valvular regurgitation or stenosis C. Dilated cardiomyopathy D. Hypertrophic cardiomyopathy E. Cardiac amyloidosis 4. Active malignancy 5. Pregnancy or breast-feeding 6. Life expectancy \< 1 year 7. Refuse or unable to understand the written informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Severance Cardiovascular Hospital Yonsei University
Seoul, South Korea