Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure

Recruiting now · Phase 4

Conditions studied: Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT03445949

Run by

National Institute of Cardiology, Warsaw, Poland

People needed

200

Starts

2018-01-23

Expected to finish

2027-06-23

Last updated by the study team

2023-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Participant is willing to sign the study informed consent form

You may not qualify if…

• 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
• Peridevice leak >5mm on imaging study preceding enrollment
• Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment
• Life expectancy of fewer than 18 months
• Participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months
• Chronic kidney disease stage IV and V
• Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with negative pregnancy test 24 hours prior to randomization if <55 years old) or after surgical sterilization

Where it is running

• National Institute of Cardiology — Warsaw, Masovian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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