Comparing left atrial appendage occlusion to novel oral anticoagulation for preventing strokes in atrial fibrillation patients
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF)
NA · University of Aarhus · NCT03642509
This study is testing whether a procedure to close off a part of the heart can prevent strokes as well as new blood thinners in patients with atrial fibrillation who have had a stroke before.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Locations | 15 sites (Aarhus, Central Jutland and 14 other locations) |
| Trial ID | NCT03642509 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of left atrial appendage occlusion (LAAO) compared to novel oral anticoagulants (NOAC) in preventing strokes and other serious outcomes in patients with atrial fibrillation who have experienced a prior ischemic stroke or transient ischemic attack. It is a multicenter, randomized, open-label trial designed to assess the non-inferiority of LAAO against NOAC therapy. A total of 750 patients will be enrolled, and outcomes will be evaluated over a follow-up period of up to 10 years through both in-office visits and national patient registries. The primary outcome will focus on a composite of stroke, systemic embolism, major bleeding, and all-cause mortality.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented non-valvular atrial fibrillation and a history of ischemic stroke or transient ischemic attack within the last 6 months.
Not a fit: Patients with a modified Rankin scale score greater than 3, severe renal impairment, or contraindications to long-term aspirin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective alternative to anticoagulation therapy for stroke prevention in atrial fibrillation patients.
How similar studies have performed: While previous studies have shown the effectiveness of LAAO compared to warfarin, this specific comparison with NOAC therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarhus, Central Jutland and 14 other locations
- Aarhus University Hospital — Aarhus, Central Jutland, Denmark (RECRUITING)
- Odense University Hospital — Odense, Region Syddanmark, Denmark (ACTIVE_NOT_RECRUITING)
- Aalborg University Hospital — Aalborg, The North Denmark Region, Denmark (RECRUITING)
- Rigshospitalet — Copenhagen, Denmark (NOT_YET_RECRUITING)
- Regional Hospital West Jutland — Holstebro, Denmark (RECRUITING)
- Helsinki University Central Hospital — Helsinki, Finland (RECRUITING)
- Oulu University Hospital — Oulu, Finland (WITHDRAWN)
- Turku University Hospital — Turku, Finland (NOT_YET_RECRUITING)
- Jena University Hospital — Jena, Germany (RECRUITING)
- Haukeland University Hospital — Bergen, Norway (RECRUITING)
- Oslo University Hospital — Oslo, Norway (RECRUITING)
- Trondheim University Hospital — Trondheim, Norway (NOT_YET_RECRUITING)
- Sahlgrenska University Hospital — Gothenburg, Sweden (RECRUITING)
- Skånes University Hospital — Lund, Sweden (NOT_YET_RECRUITING)
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
Study contacts
- Study coordinator: Kasper Korsholm, MD
- Email: kasperkorsholm@clin.au.dk
- Phone: 004578452254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Stroke, Left atrial appendage occlusion, Novel oral anticoagulation