NCT06401616

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,220 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	OAC will be discontinued for the duration of the trial	Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban

Timeline

• Start date: 2024-05-21
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2024-05-07
• Last updated: 2024-05-23

Locations

6 sites across 1 country: Denmark