Clinical trial NCT03108872: Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation
Official title: Long Term Clinical Outcomes of Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation; From Korean Multicenter Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Anticoagulants
Atrial Appendage
Stroke
Lead sponsor: Sejong General Hospital
Sponsor class: OTHER
Collaborators: name: Korea University Anam Hospital
name: Yonsei University
name: Gachon University Gil Medical Center
name: Ulsan University Hospital
First posted: 2017-04-11
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atrial fibrillation with high risk of ischemic stroke or systemic embolism

Brief summary: We will compare long-term effectiveness and safety in patients with atrial fibrillation treated with left atrial appendage occlusion versus new oral anticoagulants to prevent ischemic stroke from multicenter registry data

Detailed description: Atrial fibrillation (AF) is associated with a substantial risk of stroke and systemic embolism. Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation and high risk of ischemic stroke. However, their use is limited by a narrow therapeutic range, increased risk of intracranial hemorrhage, the need for continuous monitoring of INR, and drug or food interaction. New oral anticoagulants (NOACs), the direct thrombin inhibitor and the factor Xa inhibitor, have settled these limitations of warfarin therapy. In four pivotal phase 3 clinical trials and their meta-analysis, NOACs have been shown to significantly reduce ischemic stroke, intracranial hemorrhage, and mortality, and had similar major bleeding as for warfarin in patients with non-valvular atrial fibrillation (NVAF). Another new treatment strategy for prevention of stroke is left atrial appendage occlusion (LAAO). Left atrial appendage has been considered to be an origin of thrombi more than 90% of cases. The concept that exclusion of LAA from the circulation reduces the risk of stroke in patients with NVAF is therefore being tested in clinical studies. LAAO with Watchman device and only aspirin were proved to be non-inferior to warfarin for ischemic stroke prevention or systemic embolism. And, LAAO reduced significantly cardiac death and hemorrhagic stroke compared to warfarin in a long-term follow up. Up to date, there was no study to compare long-term clinical outcomes between LAAO and NOACs, which are two new treatment strategies for stroke prevention in patients with NVAF.

Eligibility criteria: Inclusion Criteria:

1. Patients with atrial fibrillation, who LAAO or NOAC to prevent ischemic stroke or systemic embolism
2. Patients with CHA2DS2-VASc score \>1

Exclusion Criteria:

1. Patients who failed to successfully implant LAAO
2. Patients who receive new oral anticoagulant less than 6 months without clinical events
3. Patients with mitral stenosis more than mild grade
4. Patients with prosthetic heart valve

Primary outcomes:
measure: Primary effectiveness endpoint
timeFrame: During 4 years
measure: Primary safety endpoint
timeFrame: During 4 years
Secondary outcomes:
measure: Cardiovascular or unexplained death
timeFrame: During 4 years
measure: Ischemic stroke or systemic embolism
timeFrame: During 4 years
measure: Hemorrhagic stroke
timeFrame: During 4 years
measure: Major bleeding
timeFrame: During 4 years
measure: Serious device-related complications
timeFrame: During 4 years
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
state: Gyeonggi
Study officials:
References:
citation: Kim JS, Lee H, Suh Y, Pak HN, Hong GR, Shim CY, Yu CW, Lee HJ, Kang WC, Shin ES, Choi RK, Kar S, Park JW, Lim DS, Jang Y. Left Atrial Appendage Occlusion in Non-Valvular Atrial Fibrillation in a Korean Multi-Center Registry. Circ J. 2016 Apr 25;80(5):1123-30. doi: 10.1253/circj.CJ-15-1134. Epub 2016 Mar 17.