Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
NCT ID: NCT06401616
Last Updated: 2024-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1220 participants
INTERVENTIONAL
2024-05-21
2028-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
The investigators responsible for data collection and the Endpoint Adjudication Committee will be blinded to the randomization.
Study Groups
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Discontinue OAC
OAC stopped for the duration of the trial
OAC will be discontinued for the duration of the trial
Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban
Continue OAC
OAC continued for the duration of the trial
No interventions assigned to this group
Interventions
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OAC will be discontinued for the duration of the trial
Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban
Eligibility Criteria
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Inclusion Criteria
* Previously undergone any type of cardiac surgical procedure including any type of surgical LAA closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the NationalPatient Register (NPR), the Danish Heart Registry (DHR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 til 3 months prior to inclusion in the project.
* Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record
* Informed consent
Exclusion Criteria
* Patient specific conditions requiring OAC (e.g.mechanical valve, previous pulmonary embolism)
* Renal impairment (estimated glomerular filtration rate \< 30)
* Allergy to contrast media
* Pregnancy or breastfeeding
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Gødstrup Hospital
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Population Health Research Institute
OTHER
Region of Southern Denmark
OTHER
Odense University Hospital
OTHER
Responsible Party
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Principal Investigators
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Lars Peter Riber, DMSc
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Christian Carranza, M.D.
Role: primary
Kristian Eskesen, MD
Role: primary
Morten Böttcher, M.D.
Role: primary
Louise Rasmussen, M.D.
Role: primary
Ivy Modrau, MD
Role: primary
References
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Gosvig K, Goller J, Hansson NH, Brandes A, Modrau I, Rasmussen LF, Eskesen K, Jensen AKG, Belley-Cote E, Whitlock R, Riber LPS. Rationale and design of the anticoagulant therapy after left atrial appendage closure (ATLAAC) trial. Am Heart J. 2025 Sep;287:86-93. doi: 10.1016/j.ahj.2025.04.015. Epub 2025 Apr 15.
Other Identifiers
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2022-502986-92-00
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502986-92-00
Identifier Type: -
Identifier Source: org_study_id
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