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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
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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandNot yet recruiting
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
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KatowicePolandNot yet recruiting
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
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ŁódźPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandNot yet recruiting
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandNot yet recruiting
Szpitale Pomorskie Sp. z o.o.
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WejherowoPolandNot yet recruiting
Śląskie Centrum Chorób Serca w Zabrzu
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ZabrzePolandNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.