Rationale and design of the anticoagulant therapy after left atrial appendage closure (ATLAAC) trial.
Kristina Gosvig, Julie Goller, Nils Henrik Hansson...
https://pubmed.ncbi.nlm.nih.gov/40246048Actively Recruiting
Led by Odense University Hospital · Updated on 2024-05-23
1220
Participants Needed
6
Research Sites
N/A
Total Duration
O
Odense University Hospital
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
Researchers are evaluating the safety of stopping anticoagulant therapy in patients with atrial fibrillation who have had surgical closure of the left atrial appendage (LAA). This procedure is often done during cardiac surgery to reduce the risk of stroke and blood clots, which may allow patients to avoid ongoing blood thinners that increase bleeding risk. The ATLAAC trial is designed as a phase 4 randomized study to compare continued versus discontinued anticoagulation in this group. Participants will have undergone cardiac surgery with LAA closure verified by a cardiac CT scan. Those with successful closure are randomly assigned to either stop taking oral anticoagulants (such as warfarin or direct oral anticoagulants) or to continue them for the trial duration. This allows the trial to assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding events between the two approaches. During the approximately four-year follow-up, participants will be monitored for stroke severity, transient ischemic attacks, mortality rates, minor bleeding, and other cardiovascular events. Quality of life and patient satisfaction with treatment will also be evaluated at baseline and yearly intervals. The trial involves regular assessments to ensure safety and to measure key health outcomes related to anticoagulation status after LAA closure.
CONDITIONS
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 years
Participants are randomized to either discontinue or continue oral anticoagulant therapy for the duration of the trial.
Regular visits according to study schedule over 4 years
Total: 6 locations
1
Rigshospitalet
Copenhagen, Capital Region, Denmark
Not Yet Recruiting
2
Gentofte Hospital
Gentofte Municipality, Capital Region, Denmark
Actively Recruiting
3
Regionshospital Gødstrup
Herning, Central Jutland, Denmark
Not Yet Recruiting
4
Aalborg university hospital
Aalborg, North Denmark, Denmark
Not Yet Recruiting
5
Århus Universitetshospital
Aarhus, Region Midt, Denmark
Actively Recruiting
6
Odense University Hospital
Odense, Region Syddanmark, Denmark
Actively Recruiting
K
Kristina Gosvig, M.D.
J
Julie Goller, M.D.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Kristina Gosvig, Julie Goller, Nils Henrik Hansson...
https://pubmed.ncbi.nlm.nih.gov/40246048