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Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation

RecruitingNAAges 18 Years - anyAllUniversity of Aarhus
NCT03642509 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Atrial fibrillation (AF) is progressively common, and increases the risk of stroke five-fold. Oral anticoagulation is the mainstay therapy; however, it increases the risk of bleeding. Moreover, 30% with AF and at risk of stroke are not in relevant anticoagulation. The randomized PROTECT-AF trial has demonstrated the superiority of left atrial appendage occlusion (LAAO) as compared to warfarin for prevention of the combined endpoint of stroke, major bleeding and cardiovascular mortality. However, studies comparing LAAO to therapy with novel oral anticoagulants (NOAC) have not been carried out. This study aims to assess the effect of left atrial appendage occlusion (LAAO) to reduce the incidence of stroke, systemic embolism, major bleeding and all-cause mortality in patients with atrial fibrillation (AF) and a prior ischemic stroke or transient ischemic attack (TIA).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * documented non-valvular atrial fibrillation (paroxysmal, persistent or permanent) * Eligible for long-term Novel Oral Anticoagulation (NOAC) therapy * Ischemic stroke within the recent 6 months verified by neuroimaging, or * Transient ischemic attack within 6 months with proven cerebral ischemia based on cerebral magnetic resonance imaging (MRI) Exclusion Criteria: * Modified rankin scale \> 3 at time of enrollment * Glomerular filtration rate (GFR) below 15 ml/min/1.73 m2 * Contraindication towards long-term aspirin therapy * Planned combined cardiovascular interventional procedures at the time of enrollment * Terminal illness or cancer with life expectancy less than 2 years.
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What it tests

  • Left atrial appendage occlusion
  • NOAC
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Where

15 sites
Aarhus University Hospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark
Aalborg University Hospital
Aalborg, Denmark
Rigshospitalet
Copenhagen, Denmark
Regional Hospital West Jutland
Holstebro, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Oulu University Hospital
Oulu, Finland
Turku University Hospital
Turku, Finland

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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