Clinical trial NCT06401616: Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Official title: Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure: a Randomized Non-inferiority Trial (The ATLAAC Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation
Left Atrial Appendage Absent
Anticoagulant Adverse Reaction
Keywords: Atrial fibrillation
Anticoagulant treatment
Surgical left atrial appendage closure
surgical left atrial appendage occlusion
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Gødstrup Hospital
name: Aarhus University Hospital
name: Aalborg University Hospital
name: Population Health Research Institute
name: Region of Southern Denmark
First posted: 2024-05-07
Enrollment: 1220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either continue or discontinue oral anticoagulant therapy
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* 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:

* Not receiving OAC (warfarin/DOAC)
* 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

Primary outcomes:
measure: Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings
timeFrame: After 128 primary outcome events (approx 4 years)
Secondary outcomes:
measure: Severity of stroke
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Occurence of transient ischemic attacks
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Occurence of all-cause stroke
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Rate of all-cause mortality
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Rate of cardiovascular mortality
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Occurence of minor bleeding
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Number of participants who receive blood transfusion
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Occurence of myocardial infarction
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Occurence of deep venous thrombosis
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Occurence of pulmonary embolism
timeFrame: After 128 primary outcome events (approx 4 years)
measure: Health-related Quality of Life (HRQOL)
timeFrame: Baseline (day 0) and 1 and 2 years after inclusion
measure: Patient-reported satisfaction with overall medical treatment
timeFrame: Baseline (day 0) and 1 and 2 years after inclusion
measure: Patient-reported satisfaction with anticoagulant treatment
timeFrame: Baseline (day 0) after inclusion
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Region Hovedstaden
city: Gentofte
country: Denmark
facility: Gentofte Hospital
state: Region Hovedstaden
city: Herning
country: Denmark
facility: Regionshospital Gødstrup
state: Region Midtjylland
city: Århus
country: Denmark
facility: Århus Universitetshospital
state: Region Midt
city: Aalborg
country: Denmark
facility: Aalborg university hospital
state: Region Nordjylland
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Syddanmark
Study officials:
affiliation: Odense University Hospital
name: Lars Peter Riber, DMSc
role: PRINCIPAL_INVESTIGATOR
References: