Antiplatelet Medicine Duration After Heart Procedure in Dialysis Patients
Compares blood-thinning medicine lengths after heart closure in dialysis patients with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events following Left
Atrial Appendage Closure – Chronic Kidney Disease (SAFE LAAC CKD). Comparative Health
Effectiveness Ancillary Study – PILOT
Key facts
- Where
- Gdansk, Katowice, Łódź, Lublin, Poznan, Warsaw, Wejherowo, and Zabrze, PolandSee the 10 sites
- Phase
- Phase 4
Where in Poland
- Uniwersyteckie Centrum KliniczneGdansk, PolandNot yet recruiting
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandNot yet recruiting
- SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w ŁodziŁódź, PolandNot yet recruiting
- Uniwersytecki Szpital Kliniczny nr 4 w LublinieLublin, PolandNot yet recruiting
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandNot yet recruiting
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyWarsaw, PolandNot yet recruiting
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu MedycznegoWarsaw, PolandNot yet recruiting
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, PolandNot yet recruiting
- Szpitale Pomorskie Sp. z o.o.Wejherowo, PolandNot yet recruiting
- Śląskie Centrum Chorób Serca w ZabrzuZabrze, PolandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Trial code
- NCT05660811EU 2024-516384-93-00
- Record updated
- 25 April 2025
- Original description
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 in patients with end-stage renal disease on chronic dialysis (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 in patients with end-stage renal disease on chronic dialysis (nonrandomized comparison).Read full original descriptionShow less
Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events following Left Atrial Appendage Closure – Chronic Kidney Disease (SAFE LAAC CKD). Comparative Health Effectiveness Ancillary Study – PILOT
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 in patients with end-stage renal disease on chronic dialysis (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 in patients with end-stage renal disease on chronic dialysis (nonrandomized comparison).
Inclusion: Successful percutaneous left atrial appendage occlusion with Amplatzer or WATCHMAN devices within 37 days prior to randomization 2. End-stage renal disease treated with chronic hemodialysis or chronic peritoneal dialysis 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: 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 enrolment 9. 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.