short postimplantation dual antiplatelet therapyextended postimplantation dual antiplatelet therapylong-term treatment with a single antiplatelet agent6 months treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy: continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device
extended postimplantation dual antiplatelet therapy: stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device
long-term treatment with a single antiplatelet agent: continuing long-term treatment with single antiplatelet agent
6 months treatment with a single antiplatelet agent: continuing single antiplatelet agent up until 6 months
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus) — 17 months Event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years);
Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5) — 17 months Event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years);
Trial sites (1)
Facility
City
Region
Status
National Institute of Cardiology
Warsaw
Masovian Voivodeship
Recruiting
More National Institute of Cardiology, Warsaw, Poland trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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