Aspirin alone vs aspirin plus clopidogrel after left atrial appendage closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label study compares two antithrombotic strategies after left atrial appendage closure in adults with nonvalvular atrial fibrillation. The primary goal is to see if aspirin alone is as effective as aspirin plus clopidogrel in minimizing new ischemic brain lesions on MRI. Secondary assessments include neurological function and safety related to bleeding. Participants must have LAAC indication, provide consent, and be evaluated by a heart team. The study seeks to inform post-procedural antithrombotic guidelines in higher-bleeding-risk patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bordeaux University Hospital
  Pessac, France Recruiting
• Toulouse University Hospital
  Toulouse, France Not yet recruiting

Study contacts

• Principal investigator: Zakaria JALAL, MD — University Hospital, Bordeaux
• Study coordinator: Zakaria JALAL, MD
• Email: zakaria.jalal@chu-bordeaux.fr
• Phone: (0)5 57 65 64 65

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.