AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvular atrial fibrillation (AF). The primary objective of the study is to evaluate the efficacy of Aspirin versus Aspirin + Clopidogrel after LAAC by comparing the occurrence of ischemic lesions on cerebrovascular magnetic resonance imaging (MRI) studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Double antiplatelet therapy
DrugOne sachet of aspirin 160 mg and one tablet of clopidogrel 75 mg per day.during 3 months
Aspirin
DrugOne sachet of aspirin 160 mg per day during 3 months
Brain MRI
DeviceTwo cerebral Magnetic Resonance Imaging (MRI) examinations will be carried out (D0 and D90).
Neurological tests
Other interventionNeurological assessment with the implementation of the modified rankin, National Institute of Health Stroke Score (NIHSS), and Montreal Cognitive Assessment (MoCA) tests (D1 and M3)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Double antiplatelet therapy groupSham comparator 3 interventions
Group B: Aspirin groupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change from baseline of ischaemic lesions number at 3 months appearing on brain MRI scans
Assessment of number of ischaemic lesions appearing on diffusion sequences and/or (Fluid Attenuated Inversion Recovery) FLAIR between cerebral MRI scans at D0 after implantation and after 3 months of antithrombotic treatment. The interpretation of the MRI scans will be centralised and carried out by an independent Corelab in the neuro radiology imaging department of Bordeaux University Hospital. These analyses will be carried out by two independent radiologists. In the event of disagreements or inconsistent values, a third review will be carried out by a third independent radiologist. The final value of the different variables will be reduced to the average of these 2 or 3 interpretations.
Time frame
Baseline and 3 monthsSecondary outcomes
1
Occurrence of symptomatic cerebral ischaemic events
Number of cerebral infarctions and transient ischaemic attacks identified by MRI and systematic neurological examination at D1 and M3, and at any time in the event of a symptomatic event.
Time frame
From day 1 to month 32
Occurrence of systemic thromboembolic events
Number of systemic thromboembolic events that will be identified when clinically symptomatic
Time frame
From day 1 to month 33
Occurrence of cerebral haemorrhagic events
Number of cerebral haemorrhagic events that will be identified by MRI and by systematic neurological examination at D0 and M3, and at any time in the event of a symptomatic event
Time frame
From day 0 to month 34
Occurence of systemic bleeding events
Number of systemic bleeding events that will be identified when clinically symptomatic
Time frame
From day 1 to month 3Sponsors and contacts
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Source ClinicalTrials.gov