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NCT04796714RecruitingPhase 4

AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE

Source: ClinicalTrials.gov · Last updated 10 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
60 (estimated)
First submitted
8 Mar 2021
Start date
3 Oct 2022
Primary completion date
3 May 2027
Lead sponsor
University Hospital, Bordeaux
NCT number
NCT04796714
EU CT number
2024-515774-27-00
EudraCT number
2020-004263-84

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 60
  • From 3 Oct 2022 to the primary completion date, 3 May 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Unacceptable bleeding risk with double antiplatelet therapy decided by the physician who contraindicated oral anticoagulation
  • Major disease resulting in a life expectancy of \< 1 year
  • Severe and inherited bleeding disorder
  • Contraindication to MRI: claustrophobia or inability to lie still for exam time, implantable pacemaker or defibrillator, intracorporeal metal foreign body (especially intraocular), intracranial metal clip, cochlear implant, cardiac valve prosthesis type Starr-Edwards pre 6000, or biomedical device type insulin pump or neurostimulator.

Lab values

  • Known hypersensitivity to aspirin and/or clopidogrel:
    • Hypersensitivity to clopidogrel, acetylsalicylic acid, or one of the excipients or other nonsteroidal anti-inflammatory drugs (cross-reaction).
    • Asthma or a history of asthma with or without nasal polyps induced by salicylates or substances of close activity, including nonsteroidal anti-inflammatory drugs.
    • Evolving peptic ulcer or history of gastric hemorrhage or perforation after treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
    • Any constitutional or acquired haemorrhagic disease.
    • 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).
    • Severe liver failure.
    • Severe kidney failure (Creatinine light \< 30ml/min).
    • Uncontrolled severe heart failure

Age

  • Woman of childbearing age who does not benefit from highly effective contraception (CTFG recommendation on highly effective contraceptive methods: oral, intravaginal or transdermal estrogeno-progestin contraception; progestin-based oral, injectable or implantable contraception; intrauterine device; hormonal intrauterine device; female sterilization (occlusion of the fallopian tubes))

Other

  • Minors
  • LAAC contraindication : left appendage thrombus
  • Guardianship
  • Curatorship
  • Pregnancy or child-bearing potential female
  • Iode contraindication
  • Patient already participating in another category 1 interventional research
  • Patient in a period of exclusion relative to another research protocol.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
PessacFranceRecruiting
Centre Hospitalier Universitaire de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
Coordinator of this site? Confirm its status
Toulouse Cedex 9FranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.