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
- Diseases
- Stroke, Atrial fibrillation
- 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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.