drugset / Trial / NCT06401616

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

NCT06401616

RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start
2024-05-21
Primary completion
2028-03
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Apixaban Small molecule
Subject Dabigatran Unknown
Subject Edoxaban Small molecule
Subject Rivaroxaban Other / unclassified
Subject Warfarin Small molecule

Indications