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)
MACE (major adverse cardiac event) — 18 months Duration for first occurrence of major cardiovascular events after patient registration: ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death
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.
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