NCT03642509Recruiting
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF)
Source: ClinicalTrials.gov · Last updated 21 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 750 (estimated)
- First submitted
- 6 Jul 2018
- Start date
- Jan 2019
- Primary completion date
- Jan 2026
- Lead sponsor
- University of Aarhus
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT03642509
What you commit to
- Study type: Interventional
- Planned participants: 750
- From Jan 2019 to the primary completion date, Jan 2026
- 15 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication towards long-term aspirin therapy
Other illness
- Terminal illness or cancer with life expectancy less than 2 years.
Lab values
- Glomerular filtration rate (GFR) below 15 ml/min/1.73 m2
Other
- Modified rankin scale \> 3 at time of enrollment
- Planned combined cardiovascular interventional procedures at the time of enrollment
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jena University Hospital Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Not yet recruiting |
| Regional Hospital West Jutland Coordinator of this site? Confirm its status | Holstebro | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Active, not recruiting |
| Helsinki University Central Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Withdrawn |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Not yet recruiting |
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Trondheim University Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Not yet recruiting |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Skånes University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Not yet recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.