D,L-LYSINE ACETYLSALICYLATE (acetylsalicylic acid) for Atrial fibrillation | Left atrial appendage occlusion

Inclusion criteria

• {"criterion_text":"- Male or female patients with LAAC indication according to CNEDiMTS guidelines\n- Age ≥ 18 years\n- Written informed consent provided by the patient\n- Heart team approval: multidisciplinary team including interventional cardiologists, neurologists and other physicians discussing the definitive contraindication for anticoagulation\n- Registration under social security system"}

Exclusion criteria

• {"criterion_text":"- Minors\n- 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)\n- Known hypersensitivity to aspirin and/or clopidogrel - Severe liver failure\n- Known hypersensitivity to aspirin and/or clopidogrel - Severe kidney failure (Creatinine light < 30ml/min)\n- Known hypersensitivity to aspirin and/or clopidogrel - Uncontrolled severe heart failure\n- 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.\n- Adults under legal protection (guardianship, curatorship or safeguard of justice)\n- Patient deprived of liberty by judicial or administrative decision,\n- Pregnant or breast-feeding women\n- 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))\n- Iode contraindication\n- Unacceptable bleeding risk with double antiplatelet therapy decided by the physician who contraindicated oral anticoagulation\n- Patient already participating in another category 1 interventional research\n- Patient in a period of exclusion relative to another research protocol\n- LAAC contraindication : left appendage thrombus\n- Major disease resulting in a life expectancy of < 1 year\n- Severe and inherited bleeding disorder\n- Known hypersensitivity to aspirin and/or clopidogrel - Hypersensitivity to clopidogrel, acetylsalicylic acid, or one of the excipients or other nonsteroidal anti-inflammatory drugs (crossreaction)\n- Known hypersensitivity to aspirin and/or clopidogrel - Asthma or a history of asthma with or without nasal polyps induced by salicylés or substances of close activity, including nonsteroidal antiinflammatory drugs\n- 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\n- Known hypersensitivity to aspirin and/or clopidogrel - Any constitutional or acquired haemorrhagic disease"}

Primary endpoints

• {"endpoint_text":"- The primary end point is the number of ischemic lesions appearing on the diffusion sequences and/or FLAIR between cerebral MRI scans performed within 24 hours of the procedure and after 3 months of anti-thrombotic treatment.","definition_or_measurement_approach":"Count of ischemic lesions on diffusion and/or FLAIR MRI sequences comparing scans performed within 24 hours post-procedure and at 3 months of anti-thrombotic treatment."}

Secondary endpoints

• {"endpoint_text":"- Symptomatic ischemic cerebral events (cerebral infarction and transient ischemic attacks) identified by MRI and systematic neurological examination at D1 and M3, and at any time in the event of a symptomatic event","definition_or_measurement_approach":"Identified by MRI and systematic neurological examination at Day 1 and Month 3, and at any time if symptomatic."}
• {"endpoint_text":"- Systemic thromboembolic events that will be identified when clinically symptomatic","definition_or_measurement_approach":"Clinically identified symptomatic systemic thromboembolic events."}
• {"endpoint_text":"- Cerebral hemorrhagic events that will be identified by MRI (T2 sequence*) and by systematic neurological examination at D1 and M3, and at any time in the event of a symptomatic event.","definition_or_measurement_approach":"Identified by MRI (T2*) and systematic neurological exam at Day 1 and Month 3, and at any time if symptomatic."}
• {"endpoint_text":"- Systemic bleeding events that will be identified when clinically symptomatic","definition_or_measurement_approach":"Clinically identified symptomatic systemic bleeding events."}
• {"endpoint_text":"- Neurological deficits and their functional impact, which will be measured with the NIHSS (National Institute of Health Stroke Score) and by the modified Rankin score at each post-implantation assessment time (D1 and M3)","definition_or_measurement_approach":"Measured using NIHSS and modified Rankin score at Day 1 and Month 3 post-implantation."}
• {"endpoint_text":"- Cognitive assessment of patients using the Montreal Cognitive Assessment (MoCA) scale at D1 and M3","definition_or_measurement_approach":"MoCA cognitive assessment at Day 1 and Month 3."}
• {"endpoint_text":"- Events related to the prosthesis embolization procedure and severe pericardial effusion which will be objectified by clinical evaluation and ultrasound examination","definition_or_measurement_approach":"Objectified by clinical evaluation and ultrasound (echocardiography) examinations."}
• {"endpoint_text":"- The presence of thrombus on the prosthesis, the existence of residual leakage and the degree of endothelialization which will be evaluated by cardiac CT scan at 3 months","definition_or_measurement_approach":"Evaluated by cardiac CT scan at 3 months for thrombus, residual leak and endothelialization."}
• {"endpoint_text":"- Treatment compliance will be assessed at M3 for all patients by accounting for treatments taken compared to those that should have been taken. This compliance will be correlated with thromboembolic and haemorrhagic events in order to define the accountability of the treatment strategy on these events","definition_or_measurement_approach":"Compliance assessed at Month 3 by comparing taken treatments to prescribed; correlated with thromboembolic and hemorrhagic events."}

France

Earliest CTIS Part Ii Submission Date

15-07-2024

Latest Decision Or Authorization Date

12-06-2025

Processing Time Days

332

Number Of Sites

3

Number Of Participants

60

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France