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AntiPlatelet theraPy stratEgy followiNg left atrial appenDAGe closurE
EU CTIS ID: 2024-515774-27-00
What this study is testing
Evaluate the efficacy of 2 different antithrombotic strategies (aspirin VS aspirin + clopidogrel) following LAAC by comparing the occurrence of ischemic lesions on brain MRIs performed within 24h after the procedure (D0) and after 3 months of follow-up.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients with LAAC indication according to CNEDiMTS 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
You likely can't join if
- Minors
- Known hypersensitivity to aspirin and/or clopidogrel - 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)
- Known hypersensitivity to aspirin and/or clopidogrel - Severe liver failure
- Known hypersensitivity to aspirin and/or clopidogrel - Severe kidney failure (Creatinine light < 30ml/min)
- Known hypersensitivity to aspirin and/or clopidogrel - 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), intra-ocular metal clipcranial, cochlear implant, cardiac valve prosthesis type Starr-Edwards pre 6000, or biomedical device type insulin pump or neurostimulator.
See the full eligibility criteria
- Male or female patients with LAAC indication according to CNEDiMTS 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
- Minors
- Known hypersensitivity to aspirin and/or clopidogrel - 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)
- Known hypersensitivity to aspirin and/or clopidogrel - Severe liver failure
- Known hypersensitivity to aspirin and/or clopidogrel - Severe kidney failure (Creatinine light < 30ml/min)
- Known hypersensitivity to aspirin and/or clopidogrel - 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), intra-ocular metal clipcranial, cochlear implant, cardiac valve prosthesis type Starr-Edwards pre 6000, or biomedical device type insulin pump or neurostimulator.
- Adults under legal protection (guardianship, curatorship or safeguard of justice)
- Patient deprived of liberty by judicial or administrative decision,
- Pregnant or breast-feeding women
- Woman of childbearing age who does not benefit from highly effective contraception (CTFG recommendation on highly effective contraceptive methods: oral, intravaginal or transdermal estogeno-progestin contraception; progestin-based oral, injectable or implantable contraception; intrauterine device; hormonal intrauterine device; female sterilization (occlusion of the fallopian tubes))
- Iode contraindication
- Unacceptable bleeding risk with double antiplatelet therapy decided by the physician who contraindicated oral anticoagulation
- Patient already participating in another category 1 interventional research
- Patient in a period of exclusion relative to another research protocol
- 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 (crossreaction)
- Known hypersensitivity to aspirin and/or clopidogrel - Asthma or a history of asthma with or without nasal polyps induced by salicyles or substances of close activity, including nonsteroidal antiinflammatory drugs
- Known hypersensitivity to aspirin and/or clopidogrel - Evolving peptic ulcer or history of gastric hemorrhage or perforation after treatment with acetylsalicylic acid or other nonsteroidal antiinflammatory drugs
- Known hypersensitivity to aspirin and/or clopidogrel - Any constitutional or acquired haemorrhagic disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.