Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure

ConditionAtrial Fibrillation

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorNational Institute of Cardiology, Warsaw, Poland

About this trial

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

Eligibility criteria

Qualifiers

Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before randomization

Treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization

Participant's age 18 years or older at the time of signing the informed consent form

Participant is willing to follow all study procedures; especially the randomized antiplatelet treatment regimen

Disqualifiers

Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization)

Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism)

Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol

Any known inborn or acquired coagulation disorders

Trial design

Treatments tested in this trial

short postimplantation dual antiplatelet therapy
extended postimplantation dual antiplatelet therapy
long-term treatment with a single antiplatelet agent
6 months treatment with a single antiplatelet agent

Treatment groups

200 Participants

are divided into 4 treatment groups

Sponsors and collaborators

National Institute of Cardiology, Warsaw, Poland

Lead sponsor

Medical Research Agency, Poland

Collaborator

Source ClinicalTrials.gov