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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06401616
• Other study ID #: 2022-502986-92-00
• Secondary ID: 2022-502986-92-0
• Status: Recruiting
• Phase: Phase 4
• Start date: May 21, 2024
• Est. completion date: March 2028

Study information

• Verified date: May 2024
• Source: Odense University Hospital
• Contact: Kristina Gosvig, M.D.
• Phone: +4551520696
• Email: kristina.gosvig[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1220
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant Adverse Reaction
• Atrial Fibrillation

Intervention

Drug:
• OAC will be discontinued for the duration of the trial
Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban

Locations

Country	Name	City	State
Denmark	Aalborg university hospital	Aalborg	Region Nordjylland
Denmark	Århus Universitetshospital	Århus	Region Midt
Denmark	Rigshospitalet	Copenhagen	Region Hovedstaden
Denmark	Gentofte Hospital	Gentofte	Region Hovedstaden
Denmark	Regionshospital Gødstrup	Herning	Region Midtjylland
Denmark	Odense University Hospital	Odense	Region Syddanmark

Sponsors (7)

Lead Sponsor	Collaborator
Odense University Hospital	Aalborg University Hospital, Aarhus University Hospital, Gødstrup Hospital, Open Patient data Explorative Network, Population Health Research Institute, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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