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

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Left Atrial Appendage Absent; Anticoagulant Adverse Reaction
• Intervention / Treatment: Drug: OAC will be discontinued for the duration of the trial

• Study Type: Interventional
• Enrollment (Estimated): 1220
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kristina Gosvig, M.D.; Phone Number: +4551520696; Email: kristina.gosvig@rsyd.dk
• Study Contact Backup: Name: Julie Goller, M.D.; Phone Number: 22951855; Email: julie.goller@outlook.com

Study Locations

• Denmark
  • Region Hovedstaden
    • Copenhagen, Region Hovedstaden, Denmark
      • Not yet recruiting
      • Rigshospitalet
      • Contact: Christian Carranza, M.D.
    • Gentofte, Region Hovedstaden, Denmark
      • Recruiting
      • Gentofte Hospital
      • Contact: Kristian Eskesen, MD
  • Region Midt
    • Århus, Region Midt, Denmark
      • Recruiting
      • Århus Universitetshospital
      • Contact: Ivy Modrau, MD
  • Region Midtjylland
    • Herning, Region Midtjylland, Denmark
      • Not yet recruiting
      • Regionshospital Gødstrup
      • Contact: Morten Böttcher, M.D.
  • Region Nordjylland
    • Aalborg, Region Nordjylland, Denmark
      • Not yet recruiting
      • Aalborg University Hospital
      • Contact: Louise Rasmussen, M.D.
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark
      • Recruiting
      • Odense University Hospital
      • Contact: Kristina Gosvig, M.D.; Phone Number: +4551520696; Email: kristina.gosvig@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Discontinue OAC; OAC stopped for the duration of the trial	Drug: OAC will be discontinued for the duration of the trial; Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban
No Intervention: Continue OAC; OAC continued for the duration of the trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	After 128 primary outcome events (approx 4 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of stroke	According to Scandinavian Stroke Scale (0-58), lower scores mean worse outcomes	After 128 primary outcome events (approx 4 years)
Occurence of transient ischemic attacks		After 128 primary outcome events (approx 4 years)
Occurence of all-cause stroke		After 128 primary outcome events (approx 4 years)
Rate of all-cause mortality		After 128 primary outcome events (approx 4 years)
Rate of cardiovascular mortality		After 128 primary outcome events (approx 4 years)
Occurence of minor bleeding	All types of bleeding leading to hospital contact	After 128 primary outcome events (approx 4 years)
Number of participants who receive blood transfusion		After 128 primary outcome events (approx 4 years)
Occurence of myocardial infarction		After 128 primary outcome events (approx 4 years)
Occurence of deep venous thrombosis		After 128 primary outcome events (approx 4 years)
Occurence of pulmonary embolism		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.	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.	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.	Baseline (day 0) after inclusion

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Aarhus University Hospital; Rigshospitalet, Denmark; Aalborg University Hospital; Population Health Research Institute; Gødstrup Hospital; Open Patient data Explorative Network
• Investigators: Principal Investigator: Lars Peter Riber, DMSc, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Anticoagulant treatment; Surgical left atrial appendage closure; surgical left atrial appendage occlusion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2022-502986-92-00 (Other Identifier: EU-CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No