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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • short postimplantation dual antiplatelet therapy

    Drug

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

  • extended postimplantation dual antiplatelet therapy

    Drug

    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

    Drug

    continuing long-term treatment with single antiplatelet agent

  • 6 months treatment with a single antiplatelet agent

    Drug

    continuing single antiplatelet agent up until 6 months

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: 30 days DAPT and long-term treatment with a single antiplatelet agentOther 2 interventions
Group B: 6 months DAPT and long-term treatment with a single antiplatelet agentOther 2 interventions
Group C: 30 days DAPT and 6 months treatment with a single antiplatelet agentOther 2 interventions
Group D: 6 months DAPT and 6 months treatment with a single antiplatelet agentOther 2 interventions

Trial outcomes

Primary outcomes

1

Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus)

Event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years);

Time frame
17 months
2

Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5)

Event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years);

Time frame
17 months

Secondary outcomes

1

Ischemic stroke

Event rate reported per 100 patient-years (calculated as 100\*N events/Total patient-years);

Time frame
17 months
2

Transient ischaemic attack

Event rate reported per 100 patient-years (calculated as 100\*N events/Total patient-years);

Time frame
17 months
3

Peripheral embolism

Event rate reported per 100 patient-years (calculated as 100\*N events/Total patient-years);

Time frame
17 months
4

Nonfatal myocardial infarction

Event rate reported per 100 patient-years (calculated as 100\*N events/Total patient-years);

Time frame
17 months

Other outcomes

1

Number of new ischemic brain lesions on magnetic resonance imaging

Time frame
17 months
2

Volume of new ischemic brain lesions on magnetic resonance imaging

Time frame
17 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Cardiology, Warsaw, Poland

Lead sponsor

Medical Research Agency, Poland

Collaborator

Source ClinicalTrials.gov
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