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

NCT06869811 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Left Atrial Appendage Closure

Interventions

DEVICE

LAA Closurse

LAA Closure + DOAC or OAC

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER

  • Hospital San Carlos, Madrid

    collaborator OTHER

  • Hospital Álvaro Cunqueiro

    collaborator OTHER

  • Hospital Universitari de Bellvitge

    collaborator OTHER

  • University of Salamanca

    collaborator OTHER

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2027-02-22
Completion
2027-07-22

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06869811 on ClinicalTrials.gov