Atrial Fibrillation, atrial appendage, anticoagulants, stroke, platelet aggregation inhibitors
Conditions
Interventions
Trade Name: Plavix 75mg
Pharmaceutical Form: Film-coated tablet
Other descriptive name: CLOPIDOGREL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name:
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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 - 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. - Tutorship - Curatorship - Pregnancy or child-bearing potential female - Woman of childbearing age who does not benefit from effective contraception - Iode contraindication - Patient already participating in another category 1 interventional research - Patient in a period of exclusion relative to another research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 immediately after the procedure (D0) and after 3 months of follow-up.;Secondary Objective: Describe : - the impact of each therapeutic strategy carried out during 3 months on the occurrence : * of death * Symptomatic cerebral ischemic events: cerebral infarction and TIAs. * of all symptomatic systemic thromboembolic events * cerebral hemorrhagic events * Systemic hemorrhagic events * deterioration of cognitive functions * of thrombus on prosthesis * residual leakage and endothelialization - the impact of the prosthesis implantation procedure itself on the occurrence of cardiac complications related to the procedure (pericardial effusion, ...) ;Primary end point(s): The primary end point is the number of ischemic lesions appearing on the diffusion sequences and/or FLAIR between cerebral MRI scans performed at the end of the procedure and after 3 months of anti-thrombotic treatment.;Timepoint(s) of evaluation of this end point: Day 0 and month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are : o 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. o Systemic thromboembolic events that will be identified when clinically symptomatic. o 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. o Systemic bleeding events that will be identified when clinically symptomatic. o 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). o Cognitive assessment of patients using the Montreal Cognitive Assessment (MoCA) scale at D1 and M3. o Events related to the prosthesis embolization procedure and severe pericardial effusion which will be objectified by clinical evaluation and ultrasound examination. o 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. ;Timepoint(s) of evaluation of this end point: Day 1 and month 3 | — |
Countries
France
Contacts
Public ContactProject Manager
CHU de Bordeaux
Outcome results
None listed