New study tests simpler blood thinner regimen after heart procedure
NCT ID NCT04796714
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two blood thinner strategies after left atrial appendage closure (LAAC) in people with atrial fibrillation. Sixty participants will receive either aspirin alone or aspirin plus clopidogrel for three months. The goal is to see which approach better prevents small brain lesions seen on MRI scans, which are linked to stroke risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aspirin and clopidogrel (antiplatelet drugs)
- What this could lead to
- If successful, this could show that aspirin alone is as effective as dual therapy after LAAC, potentially simplifying treatment and reducing bleeding risks.
- What could go wrong
- This is a small, early-phase trial (60 participants) focused on MRI findings, not clinical outcomes. Results may not apply to all patients, and the best strategy remains uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female patients with LAAC indication according to "Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé" (CNEDiMTS) (National Commission for the Evaluation of Medical Devices and Health Technologies) guidelines * Age ≥ 18 years * Written informed consent provided by the patient * Heart team approval: multidisciplinary team including interventional cardiologists, neurologists and other physicians discussing the definitive contraindication for anticoagulation * Registration under social security system Exclusion Criteria: * Minors * Unacceptable bleeding risk with double antiplatelet therapy decided by the physician who contraindicated oral anticoagulation * LAAC contraindication : left appendage thrombus * Major disease resulting in a life expectancy of \< 1 year * Severe and inherited bleeding disorder * Known hypersensitivity to aspirin and/or clopidogrel: * Hypersensitivity to clopidogrel, acetylsalicylic acid, or one of the excipients or other nonsteroidal anti-inflammatory drugs (cross-reaction). * Asthma or a history of asthma with or without nasal polyps induced by salicylates or substances of close activity, including nonsteroidal anti-inflammatory drugs. * Evolving peptic ulcer or history of gastric hemorrhage or perforation after treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs. * Any constitutional or acquired haemorrhagic disease. * Patients with mastocytosis, in whom the use of acetylsalicylic acid can lead to severe hypersensitivity reactions (including circulatory shocks with flushing, hypotension, tachycardia and vomiting). * Severe liver failure. * Severe kidney failure (Creatinine light \< 30ml/min). * Uncontrolled severe heart failure * Contraindication to MRI: claustrophobia or inability to lie still for exam time, implantable pacemaker or defibrillator, intracorporeal metal foreign body (especially intraocular), intracranial metal clip, cochlear implant, cardiac valve prosthesis type Starr-Edwards pre 6000, or biomedical device type insulin pump or neurostimulator. * Guardianship * Curatorship * Pregnancy or child-bearing potential female * Woman of childbearing age who does not benefit from highly effective contraception (CTFG recommendation on highly effective contraceptive methods: oral, intravaginal or transdermal estrogeno-progestin contraception; progestin-based oral, injectable or implantable contraception; intrauterine device; hormonal intrauterine device; female sterilization (occlusion of the fallopian tubes)) * Iode contraindication * Patient already participating in another category 1 interventional research * Patient in a period of exclusion relative to another research protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bordeaux University Hospital
RECRUITINGPessac, 33604, France
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Toulouse University Hospital
NOT_YET_RECRUITINGToulouse, 31059, France
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