Atrial FibrillationPhase 4NCT06401616
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
A Phase 4 study testing OAC will be discontinued for the duration of the trial in people with Atrial Fibrillation and Left Atrial Appendage Absent, run by Odense University Hospital at 6 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Absent, Anticoagulant Adverse Reaction
- What is being tested?
- OAC will be discontinued for the duration of the trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- 6 sitesDenmark
- Study dates
- 21 May 2024to 1 Mar 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Not yet recruiting
Aalborg university hospital
Aalborg, North Denmark
Louise Rasmussen, M.D.
- Recruiting
Århus Universitetshospital
Aarhus, Region Midt
Ivy Modrau, MD
- Not yet recruiting
Rigshospitalet
Copenhagen, Capital Region
Christian Carranza, M.D.
- Recruiting
Gentofte Hospital
Gentofte Municipality, Capital Region
Kristian Eskesen, MD
- Not yet recruiting
Regionshospital Gødstrup
Herning, Central Jutland
Morten Böttcher, M.D.
- Recruiting
Odense University Hospital
Odense, Region Syddanmark
Kristina Gosvig, M.D., +4551520696, kristina.gosvig@rsyd.dk
About this study
Official title: Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure: a Randomized Non-inferiority Trial (The ATLAAC Trial)
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
- Being tested
- OAC will be discontinued for the duration of the trial
- Keywords
- Atrial fibrillation, Anticoagulant treatment, Surgical left atrial appendage closure, surgical left atrial appendage occlusion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OAC will be discontinued for the duration of the trialDrug
Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban
| Study group | Role | What they receive |
|---|---|---|
| Discontinue OAC | Experimental | OAC stopped for the duration of the trial Receives: Drug: OAC will be discontinued for the duration of the trial |
| Continue OAC | No intervention | OAC continued for the duration of the trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings
Composite endpoint including the occurrence of ischemic stroke, peripheral arterial embolism, and major bleeding (ISTH definition)
Measured: After 128 primary outcome events (approx 4 years)
Secondary outcomes (13)
Severity of stroke
According to Scandinavian Stroke Scale (0-58), lower scores mean worse outcomes
Measured: After 128 primary outcome events (approx 4 years)
Occurence of transient ischemic attacks
Measured: After 128 primary outcome events (approx 4 years)
Occurence of all-cause stroke
Measured: After 128 primary outcome events (approx 4 years)
Rate of all-cause mortality
Measured: After 128 primary outcome events (approx 4 years)
Rate of cardiovascular mortality
Measured: After 128 primary outcome events (approx 4 years)
Occurence of minor bleeding
All types of bleeding leading to hospital contact
Measured: After 128 primary outcome events (approx 4 years)
Number of participants who receive blood transfusion
Measured: After 128 primary outcome events (approx 4 years)
Occurence of myocardial infarction
Measured: After 128 primary outcome events (approx 4 years)
Occurence of deep venous thrombosis
Measured: After 128 primary outcome events (approx 4 years)
Occurence of pulmonary embolism
Measured: After 128 primary outcome events (approx 4 years)
Health-related Quality of Life (HRQOL)
EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score to evaluate generic HRQOL (0-100). Higher scores mean better quality of life.
Measured: Baseline (day 0) and 1 and 2 years after inclusion
Patient-reported satisfaction with overall medical treatment
Treatment Satisfaction Questionnaire (TSQM) to evaluate satisfaction related to their overall medical treatment. TSQM scoring is by domain and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher scores indicate higher patient satisfaction with medication.
Measured: Baseline (day 0) and 1 and 2 years after inclusion
Patient-reported satisfaction with anticoagulant treatment
Anti-Clot Treatment Scale (ACTS) questionnaire to evaluate satisfaction related to oral anticoagulant treatment. The ACTS Burdens total score ranges from 12 to 60, and the ACTS Benefits total score ranges from 3 to 15. Higher ACTS Burdens and Benefits scores indicate greater satisfaction with treatment.
Measured: Baseline (day 0) after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start21 May 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either continue or discontinue oral anticoagulant therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Gødstrup Hospital, Aarhus University Hospital, Aalborg University Hospital, Population Health Research Institute, Region of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Lars Peter Riber, DMSc, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401616
- Sponsor's protocol ID
- 2022-502986-92-00
- Other IDs
- 2022-502986-92-00
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40246048