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AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE

Who is this study for? Patients with Atrial Fibrillation, Stroke
What treatments are being studied? Brain Magnetic Resonance Imaging+Neurological Tests
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Registration under social security system

Locations
Other Locations
France
Bordeaux University Hospital
RECRUITING
Pessac
Toulouse University Hospital
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Zakaria JALAL, MD
zakaria.jalal@chu-bordeaux.fr
(0)5 57 65 64 65
Backup
Amandine RUISSEL
amandine.ruissel@chu-bordeaux.fr
(0)5 57 62 32 29
Time Frame
Start Date: 2022-10-03
Estimated Completion Date: 2027-05-03
Participants
Target number of participants: 60
Treatments
Sham_comparator: Double antiplatelet therapy group
Patient randomized in this group will receive 1 tablet containing clopidogrel 75 mg and 1 bag containing aspirin 160 mg as treatment. This treatment will start on the day of LAAC procedure and continued for 3 months.
Experimental: Aspirin group
Patients randomized in this group: will receive 1 bag containing aspirin 160 mg as treatment. This treatment will start on the day of LAAC procedure and continued for 3 months.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov

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