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New treatment option for Atrial Fibrillation
Official title AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE
ClinicalTrials.gov ID: NCT04796714
What this study is testing
What is Double antiplatelet therapy?
Double antiplatelet therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients with LAAC indication according to "Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé"...
- Age ≥ 18 years
- Written informed consent provided by the patient
- Heart team approval: multidisciplinary team including treatment cardiologists, neurologists and other physicians discussing the definitive...
- Registration under social security system
You likely can't join if
- 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
- Severe and inherited bleeding disorder
- Known hypersensitivity to aspirin and/or clopidogrel:
See the full eligibility criteria
- 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...
- Age ≥ 18 years
- Written informed consent provided by the patient
- Heart team approval: multidisciplinary team including treatment cardiologists, neurologists and other physicians discussing the definitive contraindication for anticoagulation
- Registration under social security system
- 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
- Severe and inherited bleeding disorder
- 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
- 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...
- Guardianship
- Curatorship
- Pregnancy or child-bearing potential female
- 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...
- Iode contraindication
- Patient already participating in another category 1 treatment research
- Patient in a period of exclusion relative to another research protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Pessac, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pessac, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.