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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation, Stroke

In brief

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).

Key facts

Study ID

NCT03642509

Run by

University of Aarhus

People needed

750

Starts

2019-01-01

Expected to finish

2030-10-01

Last updated by the study team

2023-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Aarhus University Hospital — Aarhus, Central Jutland, Denmark (enrolling)
• Helsinki University Central Hospital — Helsinki, Finland (enrolling)
• Jena University Hospital — Jena, Germany (enrolling)
• Haukeland University Hospital — Bergen, Norway (enrolling)
• Oslo University Hospital — Oslo, Norway (enrolling)
• Sahlgrenska University Hospital — Gothenburg, Sweden (enrolling)
• Karolinska University Hospital — Stockholm, Sweden (enrolling)
• Aalborg University Hospital — Aalborg, The North Denmark Region, Denmark (enrolling)
• Regional Hospital West Jutland — Holstebro, Denmark (enrolling)
• Odense University Hospital — Odense, Region Syddanmark, Denmark
• Turku University Hospital — Turku, Finland
• Rigshospitalet — Copenhagen, Denmark
• Skånes University Hospital — Lund, Sweden
• Trondheim University Hospital — Trondheim, Norway
• Oulu University Hospital — Oulu, Finland

Full record on ClinicalTrials.gov

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