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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 6 of 6 sites
    v3
  2. Start date: Feb 29, 2024 to May 21, 2024v2 Show 5 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Interventions: OAC will be discontinued for the duration ofthe trial (Drug) to OAC will be discontinued for the duration of the trial (Drug)
    • Secondary endpoints: details revised at 3 of 13 entries
    • Site details revised at 6 of 6 sites
    • Eligibility criteria expanded, about 5 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06401616
Lead Sponsor Odense University Hospital
Collaborators: Rigshospitalet, Denmark, Gødstrup Hospital, Aarhus University Hospital, Aalborg University Hospital, Population Health Research Institute, Region of Southern Denmark
Conditions
(from sponsor)		 Atrial Fibrillation, Left Atrial Appendage Absent, Anticoagulant Adverse Reaction
Related terms Atrial Fibrillation
Enrollment 1,220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov