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Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Sponsor: Odense University Hospital
Summary
Left atrial appendage (LAA) closure has become a frequent addition to oral anticoagulation in patients with atrial fibrillation who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic embolism, which may render anticoagulation unnecessary or even harmful when considering the associated increased risk of bleeding. A clinical trial to address the need for anticoagulation after LAA closure is needed. The ATLAAC trial will enroll 1220 patients with atrial fibrillation who have previously undergone surgical LAA closure. Patients will undergo a cardiac CT-scan to determine if LAA closure was successful and patients with successful closure will be randomized to continue or discontinue anticoagulation. The trial will assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding during the randomized intervention
Official title: Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure: a Randomized Non-inferiority Trial (The ATLAAC Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1220
Start Date
2024-05-21
Completion Date
2028-03
Last Updated
2024-05-23
Healthy Volunteers
No
Interventions
OAC will be discontinued for the duration of the trial
Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban
Locations (6)
Rigshospitalet
Copenhagen, Capital Region, Denmark
Gentofte Hospital
Gentofte Municipality, Capital Region, Denmark
Regionshospital Gødstrup
Herning, Central Jutland, Denmark
Aalborg university hospital
Aalborg, North Denmark, Denmark
Århus Universitetshospital
Aarhus, Region Midt, Denmark
Odense University Hospital
Odense, Region Syddanmark, Denmark