AntiPlatelet theraPy stratEgy followiNg left atrial appenDAGe closurE

Phase 4

Not yet recruiting

Conditions: Atrial Fibrillation, atrial appendage, anticoagulants, stroke, platelet aggregation inhibitors

Registration Number: 2024-515774-27-00

Lead Sponsor: Centre Hospitalier Universitaire De Bordeaux

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 60

Inclusion 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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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.

Secondary Outcome Measures

Name	Time	Method
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		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
Systemic thromboembolic events that will be identified when clinically symptomatic		Systemic thromboembolic events that will be identified when clinically symptomatic
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.		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.
Systemic bleeding events that will be identified when clinically symptomatic		Systemic bleeding events that will be identified when clinically symptomatic
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)		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)
Cognitive assessment of patients using the Montreal Cognitive Assessment (MoCA) scale at D1 and M3		Cognitive assessment of patients using the Montreal Cognitive Assessment (MoCA) scale at D1 and M3
Events related to the prosthesis embolization procedure and severe pericardial effusion which will be objectified by clinical evaluation and ultrasound examination		Events related to the prosthesis embolization procedure and severe pericardial effusion which will be objectified by clinical evaluation and ultrasound examination
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		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
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		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

Trial Locations

Locations (2): Centre Hospitalier Universitaire De Bordeaux
🇫🇷
Pessac, France
Centre Hospitalier Universitaire De Toulouse
🇫🇷
Toulouse Cedex 9, France
Centre Hospitalier Universitaire De Bordeaux
🇫🇷Pessac, France
Zakaria JALAL
Site contact
+33557656465
zakaria.jalal@chu-bordeaux.fr

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