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RECRUITINGPhase 4INTERVENTIONAL

Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure

Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial - PILOT Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form - Participant is willing to follow all study procedures; especially the randomized antiplatelet treatment regimen - Participant is willing to sign the study willing to sign a consent form form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

short postimplantation dual antiplatelet therapy

continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device

DRUG

extended postimplantation dual antiplatelet therapy

stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device

DRUG

long-term treatment with a single antiplatelet agent

continuing long-term treatment with single antiplatelet agent

DRUG

6 months treatment with a single antiplatelet agent

continuing single antiplatelet agent up until 6 months

Locations (1)

National Institute of Cardiology
Warsaw, Masovian Voivodeship, Poland