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

NCT06401616 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1220

Last updated 2024-05-23

No results posted yet for this study

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

Interventions

DRUG

OAC will be discontinued for the duration of the trial

Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Gødstrup Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Population Health Research Institute

    collaborator OTHER

  • Region of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Lars Peter Riber, DMSc · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-21
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06401616 on ClinicalTrials.gov