NCT03445949RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 11 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 1 Feb 2018
- Start date
- 23 Jan 2018
- Primary completion date
- 23 Jun 2025
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT03445949
- EU CT number
- 2024-516382-37-00
- EudraCT number
- 2017-001826-16
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 23 Jan 2018 to the primary completion date, 23 Jun 2025
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months
- 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
Other illness
- Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol
- Any known inborn or acquired coagulation disorders
- Chronic kidney disease stage IV and V
Other
- 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)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi Coordinator of this site? Confirm its status | Łódź | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Szpitale Pomorskie Sp. z o.o. Coordinator of this site? Confirm its status | Wejherowo | Poland | Not yet recruiting |
| Śląskie Centrum Chorób Serca w Zabrzu Coordinator of this site? Confirm its status | Zabrze | Poland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.