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AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE

NCT04796714 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-10-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Double antiplatelet therapy

One sachet of aspirin 160 mg and one tablet of clopidogrel 75 mg per day.during 3 months

DRUG

Aspirin

One sachet of aspirin 160 mg per day during 3 months

DEVICE

Brain MRI

Two cerebral Magnetic Resonance Imaging (MRI) examinations will be carried out (D0 and D90).

OTHER

Neurological tests

Neurological assessment with the implementation of the modified rankin, National Institute of Health Stroke Score (NIHSS), and Montreal Cognitive Assessment (MoCA) tests (D1 and M3)

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Zakaria JALAL, MD · University Hospital, Bordeaux

  • Antoine BENARD, MD · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2024-05-03
Completion
2024-05-03

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796714 on ClinicalTrials.gov