Status:
ACTIVE_NOT_RECRUITING
Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON)
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Samsung Medical Center
Myongji Hospital
Conditions:
Acute Ischemic Stroke
Atrial Fibrillation
Eligibility:
All Genders
20+ years
Brief 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 a...
Detailed Description
Although there is a significant increase in the risk of cerebral infarction in the presence of atrial fibrillation, it is difficult to say that all cerebral infarctions occurring in patients with atri...
Eligibility Criteria
Inclusion
- Patients with acute cerebral infarction or transient ischemic attack within 14 days of symptom onset based on Last Known Normal Time.
- Patients with non-valvular atrial fibrillation including paroxysmal atrial fibrillation which is eligible for treatment with Edoxaban.
- 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
- Patients with chronic renal failure (GFR \<30 ml / min) or severe liver damage
- patients requiring warfarin medication due to prosthetic valve replacement
- patients with internal bleeding (active internal bleeding)
- bleeding diathesis
- History of acute myocardial infarction or received coronary artery procedure within 6 months before screening
- Patients who have received or are scheduled to undergo carotid stenting within 1 year
- Currently, two or more antiplatelet agents are required due to arteriosclerosis.
- Patients whose survival period is expected to be less than 12 months due to serious diseases such as terminal cancer or liver failure
- Patients who are scheduled for invasive surgery with possible uncontrolled bleeding, including major surgery
- Women who are pregnant or lactating, do not have contraception during the study
- A person who is found to be unsuitable for participation in the study due to the clinical laboratory test results or other reasons
Key Trial Info
Start Date :
October 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 27 2026
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04010955
Start Date
October 8 2019
End Date
June 27 2026
Last Update
July 11 2025
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736