A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized 1:1 to the best medical treatment (control) or the combination of LAAO and DOAC or OAC. The study's primary endpoint will be the occurrence of a cardioembolic event (ischemic stroke or arterial peripheral embolism) within the first 12 months after inclusion.
Cardioembolic* Ischemic stroke despite OAC or DOAC within the last 6 months.
Documented AF (either valvular or non-valvular AF).
LAA suitable for closure (if LAA thrombus, just distal).
Functional status at inclusion with no severe disability (mRS<4).
Absolute contraindication to OAC/DOAC.
Non-compliance of OAC/DOAC >24 hours within the last week before the index stroke (>1 dose per - - Antagonist Vit K and >2 doses per DOAC).
Lacunar Ischemic Stroke.
Symptomatic carotid disease (defined as > 50% lumen diameter narrowing on CTA, MRA, or TCD with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is < 50% lumen diameter narrowing.
Parallel
LAA Closurse
DeviceLAA Closure + DOAC or OAC
Primary Endpoint
The study's primary endpoint will be the occurrence of a cardioembolic event (ischemic stroke or arterial peripheral embolism) within the first 12 months after inclusion.
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Hospital Clinic of Barcelona
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborator
Hospital San Carlos, Madrid
Collaborator
Hospital Álvaro Cunqueiro
Collaborator
Hospital Universitari de Bellvitge
Collaborator
University of Salamanca
Collaborator
