NCT06869811

Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral

Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral (ADD-LAAO TRIAL)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Background: The prevalence of atrial fibrillation and the number of patients experiencing ischemic strokes despite being on oral anticoagulation (OAC) are both increasing. This rise presents a significant challenge due to the absence of clear and uniform treatment recommendations for these patients. To date, there is no formal combination that merges a high anticoagulant efficacy while keeping a low bleeding risk. Transcatheter left atrial appendage occlusion (LAAO) added to OAC might provide a balance between efficacy and safety. Objectives: To evaluate if, in patients with ischemic stroke despite OAC, the combination of LAAO and long-term direct OAC (DOAC) or OAC is associated with a lower incidence of recurrent cardioembolic events at 12 months as compared to the best medical treatment proposed by the neurologist. Methods: 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. Implication: This study is one of the first randomized trials comparing the LAAO+DOAC combination to optimal medical treatment in patients who have had ischemic strokes despite being on OAC. If the results confirm the superiority of LAAO+DOAC, it could lead to a paradigm shift in treatment guidelines for these patients.

Conditions

• Left Atrial Appendage Closure

Interventions

Type	Name	Description
DEVICE	LAA Closurse	LAA Closure + DOAC or OAC

Timeline

• Start date: 2024-07-22
• Primary completion: 2027-02-22
• Completion: 2027-07-22
• First posted: 2025-03-11
• Last updated: 2025-03-11

Locations

1 site across 1 country: Spain