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

Phase 4

Recruiting

• Conditions: Atrial Fibrillation; Left Atrial Appendage Absent; Anticoagulant Adverse Reaction
• Interventions: Drug: OAC will be discontinued for the duration of the trial

• Registration Number: NCT06401616
• Lead Sponsor: Odense University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-05
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-03
• Study First Posted: 2024-05-07
• Study Start: 2024-05-21
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1220

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discontinue OAC	OAC will be discontinued for the duration of the trial	OAC stopped for the duration of the trial

Primary Outcome Measures

Name	Time	Method
Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings	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 Outcome Measures

Name	Time	Method
Severity of stroke	After 128 primary outcome events (approx 4 years)	According to Scandinavian Stroke Scale (0-58), lower scores mean worse outcomes
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	After 128 primary outcome events (approx 4 years)	All types of bleeding leading to hospital contact
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)	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.
Patient-reported satisfaction with overall medical treatment	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.
Patient-reported satisfaction with anticoagulant treatment	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.

Trial Locations

Locations (6)

Rigshospitalet; 🇩🇰 Copenhagen, Region Hovedstaden, Denmark

Gentofte Hospital; 🇩🇰 Gentofte, Region Hovedstaden, Denmark

Regionshospital Gødstrup; 🇩🇰 Herning, Region Midtjylland, Denmark

Århus Universitetshospital; 🇩🇰 Århus, Region Midt, Denmark

Aalborg university hospital; 🇩🇰 Aalborg, Region Nordjylland, Denmark

Odense University Hospital; 🇩🇰 Odense, Region Syddanmark, Denmark