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NCT Number: NCT06401616

Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)

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

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Key information

Conditions

Atrial Fibrillation Anticoagulant Adverse Reaction Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Left Atrial Appendage Absent Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet, Copenhagen, Capital Region, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OAC will be discontinued for the duration of the trial

Drug

Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban

Primary outcomes

  1. Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings

    Time frame: After 128 primary outcome events (approx 4 years)

    Composite endpoint including the occurrence of ischemic stroke, peripheral arterial embolism, and major bleeding (ISTH definition)

Secondary outcomes

  1. Severity of stroke

    Time frame: After 128 primary outcome events (approx 4 years)

    According to Scandinavian Stroke Scale (0-58), lower scores mean worse outcomes

  2. Occurence of transient ischemic attacks

    Time frame: After 128 primary outcome events (approx 4 years)

  3. Occurence of all-cause stroke

    Time frame: After 128 primary outcome events (approx 4 years)

  4. Rate of all-cause mortality

    Time frame: After 128 primary outcome events (approx 4 years)

  5. Rate of cardiovascular mortality

    Time frame: After 128 primary outcome events (approx 4 years)

  6. Occurence of minor bleeding

    Time frame: After 128 primary outcome events (approx 4 years)

    All types of bleeding leading to hospital contact

  7. Number of participants who receive blood transfusion

    Time frame: After 128 primary outcome events (approx 4 years)

  8. Occurence of myocardial infarction

    Time frame: After 128 primary outcome events (approx 4 years)

  9. Occurence of deep venous thrombosis

    Time frame: After 128 primary outcome events (approx 4 years)

  10. Occurence of pulmonary embolism

    Time frame: After 128 primary outcome events (approx 4 years)

  11. Health-related Quality of Life (HRQOL)

    Time frame: Baseline (day 0) and 1 and 2 years after inclusion

    EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score to evaluate generic HRQOL (0-100). Higher scores mean better quality of life.

  12. Patient-reported satisfaction with overall medical treatment

    Time frame: Baseline (day 0) and 1 and 2 years after inclusion

    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.

  13. Patient-reported satisfaction with anticoagulant treatment

    Time frame: Baseline (day 0) after inclusion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Goller, M.D.

CONTACT

[email protected]

22951855

Kristina Gosvig, M.D.

CONTACT

[email protected]

+4551520696

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Gødstrup Hospital
  • Population Health Research Institute
  • Region of Southern Denmark
  • Rigshospitalet, Denmark

Registry information

Official study title

Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure: a Randomized Non-inferiority Trial (The ATLAAC Trial)

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 7, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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