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

Phase 4

Not yet recruiting

• Conditions: Atrial fibrillation

• Registration Number: 2024-516382-37-00
• Lead Sponsor: Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Brief Summary

1. To compare safety and efficacy of early DAPT discontinuation at 30 days postprocedure and continuation of SAPT up until 6-month vs 6 months of postprocedural DAPT (randomized comparison)

2. To compare safety and efficacy of chronic SAPT beyond 6 months postprocedure vs discontinuation of all antiplatelet treatment 6 months after LAAC (nonrandomized comparison).

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-12-16
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. Successful percutaneous left atrial appendage occlusion with Amplatzer or WATCHMAN 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

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. Diagnosis of coagulation disorders 5. Peridevice leaks greater than 5mm 6. Thrombus in the left atrium on the qualifying imaging of the left atrium 7. Life expectancy less than the duration of the trial due to noncardiovascular comorbidity 8. Enrollment into a competing trial using a non-approved devices or drugs - currently and up to 3 months prior to enrollment 9. Chronic kidney disease stage IV or V 10. Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC).		Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC).

Trial Locations

Locations (10)

Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach; 🇵🇱 Katowice, Poland

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie; 🇵🇱 Lublin, Poland

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego; 🇵🇱 Warsaw, Poland

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy; 🇵🇱 Warsaw, Poland

Uniwersytecki Szpital Kliniczny W Poznaniu; 🇵🇱 Poznan, Poland

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi; 🇵🇱 Łódź, Poland

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy; 🇵🇱 Warsaw, Poland

Uniwersyteckie Centrum Kliniczne; 🇵🇱 Gdansk, Poland

Slaskie Centrum Chorob Serca W Zabrzu; 🇵🇱 Zabrze, Poland

Szpitale Pomorskie Sp. z o.o.; 🇵🇱 Wejherowo, Poland

Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach

🇵🇱Katowice, Poland

Grzegorz Smolka

Site contact

+48323598694

kk2@gcm.pl