Active — Not RecruitingNot Applicable

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

South Korea1,200 participantsStarted 2019-10-08

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

MACE (major adverse cardiac event)

Timeframe: 18 months

Trial details

NCT IDNCT04010955

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-27

View on ClinicalTrials.gov More Acute Ischemic Stroke trials