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Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure

Study acronym: SAFE-LAAC
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 11, 2023 (before its estimated June 23, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fieldsv3
  2. Notable Primary completion date: Jan 2021 to Jun 23, 2025v2 Show 10 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 160 to 200
    • Study completion date: Jan 2022 to Jun 23, 2027
    • Interventions: extended postimplantation dual antiplatelet therapy (Drug), short postimplantation dual antiplatelet therapy (Drug) to 6 months treatment with a single antiplatelet agent (Drug), extended postimplantation dual antiplatelet therapy (Drug), long-term treatment…
    • Secondary endpoints: 8 to 11
    • Study site revised
    • Study arms: 2 to 4
    • Eligibility criteria expanded, about 3 words
    • Study description shortened, about 2 words
    • Collaborators expanded, about 4 words
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device
Trial Details
NCT Number NCT03445949
Lead Sponsor National Institute of Cardiology, Warsaw, Poland
Collaborators: Medical Research Agency, Poland
Conditions
(from sponsor)
Atrial Fibrillation
Related terms Atrial Fibrillation, Hemorrhage, Stroke
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov