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Clinical Trials in South Korea / NCT04010955
Active, not recruiting Observational

Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON)

NCT04010955 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2019-10-08
Last updated
2025-07-11

Condition(s) studied

Acute Ischemic StrokeAtrial FibrillationExtracranial AtherosclerosisIntracranial AtherosclerosisCoronary Artery AtherosclerosisPeripheral Artery StenosisAnticoagulantAntiplatelet

Investigational drug(s) / intervention(s)

Edoxaban Monotherapy →

Edoxaban Monotherapy: when the patients will be initially registered in this study, duty physicians will make a decision to give additional antiplatelet therapy in addition to standard edoxaban therapy.

Study summary

This study aims to compare the effectiveness and safety regarding treatment with standard anticoagulant only or adding antiplatelet to anticoagulant in patients with non-valvular atrial fibrillation and significant atherosclerosis including extracranial, intracranial, coronary or peripheral artery.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients with acute cerebral infarction or transient ischemic attack within 14 days of symptom onset based on Last Known Normal Time. 2. Patients with non-valvular atrial fibrillation including paroxysmal atrial fibrillation which is eligible for treatment with Edoxaban. 3. Patients with significant atherosclerosis confirmed by imaging tests on the cerebral arteries, coronary arteries, or peripheral arteries and suitable for the use of antiplatelet agents. * Significant intracranial internal stenosis confirmed by CTA or MRA * A history of coronary artery disease, meaningful findings from CTA or CAG Arterial stenosis * Peripheral arterial disease (Ankle-Brachial Index, ABI \<0.9, significant stenosis found in lower limb ultrasonography 3\) Men and women over 20 years old 4) Patients who voluntarily agreed to register the registry Exclusion Criteria: 1. Patients with chronic renal failure (GFR \<30 ml / min) or severe liver damage 2. patients requiring warfarin medication due to prosthetic valve replacement 3. patients with internal bleeding (active internal bleeding) 4. bleeding diathesis 5. History of acute myocardial infarction or received coronary artery procedure within 6 months before screening 6. Patients who have received or are scheduled to undergo carotid stenting within 1 year 7. Currently, two or more antiplatelet agents are required due to arteriosclerosis. 8. Patients whose survival period is expected to be less than 12 months due to serious diseases such as terminal cancer or liver failure 9. Patients who are scheduled for invasive surgery with possible uncontrolled bleeding, including major surgery 10. Women who are pregnant or lactating, do not have contraception during the study 11. A person who is found to be unsuitable for participation in the study due to the clinical laboratory test results or other reasons

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Asan Medical Center Seoul South Korea

More Asan Medical Center trials in South Korea

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04010955 on ClinicalTrials.gov ↗ ← All trials in South Korea