Actively Recruiting
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation
Led by University of Aarhus · Updated on 2023-12-21
750
Participants Needed
15
Research Sites
613 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
2
Odense University Hospital
Odense, Region Syddanmark, Denmark, 5000
Active, Not Recruiting
3
Aalborg University Hospital
Aalborg, The North Denmark Region, Denmark, 9000
Actively Recruiting
4
Rigshospitalet
Copenhagen, Denmark
Not Yet Recruiting
5
Regional Hospital West Jutland
Holstebro, Denmark
Actively Recruiting
6
Helsinki University Central Hospital
Helsinki, Finland
Actively Recruiting
7
Oulu University Hospital
Oulu, Finland
Withdrawn
8
Turku University Hospital
Turku, Finland, 20521
Not Yet Recruiting
9
Jena University Hospital
Jena, Germany
Actively Recruiting
10
Haukeland University Hospital
Bergen, Norway, 5021
Actively Recruiting
11
Oslo University Hospital
Oslo, Norway
Actively Recruiting
12
Trondheim University Hospital
Trondheim, Norway
Not Yet Recruiting
13
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Actively Recruiting
14
Skånes University Hospital
Lund, Sweden
Not Yet Recruiting
15
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
Research Team
K
Kasper Korsholm, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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