Optimal antiplatelet treatment after 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 - SAFE-LAAC

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001826-16-PL

Enrollment

160

Registered

2017-08-04

Start date

2018-01-11

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: clopidogrel CAS Number: 113665-84-2 Other descriptive name: CLOPIDOGREL Pharmaceutical Form: Tablet INN or Proposed INN: ACETYLSALICYLIC ACID CAS Numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Successful percutaneous left atrial appendage occlusion with one of the approved devices within 37 days prior to randomization 2. Treatment with dual antiplatelet therapy since the procedure (aspirin and clopidogrel) 3. Age >= 18 yrs 4. Participant is willing to comply with all aspects of the protocol including the assigned treatment strategy and follow-up visits 5. The participant is willing to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: 1. Any indication to chronic antiplatelet therapy other than atrial fibrillation or left atrial appendage occlusion. 2. Indications to chronic anticoagulation 3. Known allergy to clopidogrel of acetylsalicylic acid 4. Peridevice leaks greater than 5mm or thrombus in the left atrium 5. A thrombus in the left atrium 6. Life expectancy less than the duration of the trial due to noncardiovascular comorbidity 7. Enrollment into a competing trial using a non-approved devices or drugs - currently and up to 3 months prior to enrollment 8. Chronic kidney disease stage IV or V

Design outcomes

Primary

Measure	Time frame
Main Objective: SAFE-LAAC Trial has been designed to assess safety and efficacy of abridged* vs. extended** antiplatelet treatment regimens following percutaneous left atrial appendage occlusion in patients at high bleeding risk with contraindications to oral anticoagulation. * Abridged antiplatelet treatment regimen = 45 days of DAPT followed by acetylsalicylic acid up to 6 months and no antiplatelet agents thereafter. ** Extended antiplatelet treatment regimen = 6 months of DAPT followed by acetylsalicylic acid lifelong Aim: The aim of the trial is to compare safety and efficacy of abridged vs. extended antiplatelet treatment regimens in patients after left atrial appendage occlusion ;Secondary Objective: not applicable;Primary end point(s): Primary endpoint - major adverse cardiac and cerebrovascular events (MACCE) comprising composite of stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality), moderate and severe bleedings (type 2-5 BARC), thrombus in the left atrium.;Timepoint(s) of evaluation of this end point: 5 months 17 months landmark analysis at 17months of endpoints gathered between the 5 and 17months	—

Measure

Time frame

Main Objective: SAFE-LAAC Trial has been designed to assess safety and efficacy of abridged* vs. extended** antiplatelet treatment regimens following percutaneous left atrial appendage occlusion in patients at high bleeding risk with contraindications to oral anticoagulation. * Abridged antiplatelet treatment regimen = 45 days of DAPT followed by acetylsalicylic acid up to 6 months and no antiplatelet agents thereafter. ** Extended antiplatelet treatment regimen = 6 months of DAPT followed by acetylsalicylic acid lifelong Aim: The aim of the trial is to compare safety and efficacy of abridged vs. extended antiplatelet treatment regimens in patients after left atrial appendage occlusion ;Secondary Objective: not applicable;Primary end point(s): Primary endpoint - major adverse cardiac and cerebrovascular events (MACCE) comprising composite of stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality), moderate and severe bleedings (type 2-5 BARC), thrombus in the left atrium.;Timepoint(s) of evaluation of this end point: 5 months 17 months landmark analysis at 17months of endpoints gathered between the 5 and 17months

—

Secondary

Measure	Time frame
Secondary end point(s): individual components of the composite primary end point and any bleeding;Timepoint(s) of evaluation of this end point: 5 months 17 months landmark analysis at 17months of endpoints gathered between the 5 and 17months	—

Countries

Poland

Contacts

Public ContactDzial Badan Klinicznych

Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego- Panstwowy Instytut Badawczy

nauka@ikard.pl+48223434268

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026