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

NCT06401616 | Recruiting Phase 4 DMC

• 1 other identifier: 2022-502986-92-00
• Study Type: interventional
• Target: 1,220
• Locations: 1 country
• Sites: 6

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Severity of stroke

  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)

Study Arms (2)

Discontinue OAC

EXPERIMENTAL

OAC stopped for the duration of the trial

Drug: OAC will be discontinued for the duration of the trial

Continue OAC

NO INTERVENTION

OAC continued for the duration of the trial

Interventions

OAC will be discontinued for the duration of the trial DRUG

Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban

Discontinue OAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

Rigshospitalet

Copenhagen, Capital Region, Denmark

NOT YET RECRUITING

Gentofte Hospital

Gentofte Municipality, Capital Region, Denmark

RECRUITING

Regionshospital Gødstrup

Herning, Central Jutland, Denmark

NOT YET RECRUITING

Aalborg university hospital

Aalborg, North Denmark, Denmark

NOT YET RECRUITING

Århus Universitetshospital

Aarhus, Region Midt, Denmark

RECRUITING

Odense University Hospital

Odense, Region Syddanmark, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 40246048 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars Peter Riber, DMSc

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Gosvig, M.D.

CONTACT

+4551520696; kristina.gosvig@rsyd.dk

Julie Goller, M.D.

CONTACT

22951855; julie.goller@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of patients and physicians is not possible due to different types of oral anticoagulant therapy within the same interventional arm and the need for continuous monitoring of treatment with warfarin.However, since the primary outcome is not a subjectively reported outcome, lack of blinding presents less risk of bias. The investigators responsible for data collection and the Endpoint Adjudication Committee will be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to either continue or discontinue oral anticoagulant therapy

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: May 7, 2024
• Study Start: May 21, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)