Taking people in ItalyPhase 4
Comparing one blood thinner with two after left atrial appendage closure
Tests whether one antiplatelet drug works as well as two in atrial fibrillation patients.
Key facts
- Who runs it
- Fondazione Toscana Gabriele Monasterio
- Where
- Ancona, Bologna, Catania, Chivasso, Florence, Massa, Milan, Naples, Novara, Orbassano, Pisa, Rivoli, Rome, Sassari, Turin, and Vercelli, ItalySee the 18 sites
- Registry title
- Comparison between single and dual therapy with drugs that inhibits platelet aggregation in patient undergoing the percutaneous left atrial appenDAge closure (ARMYDA-AMULET in which people will be allocated by chance to receive two different options of treatment and which will involves different clinical sites)
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 606 people, planned
- Started
- 13 Oct 2021
- Expected to end
- 30 Sept 2027
- Type of study
- Interventional
- Record updated
- 25 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-valvular atrial fibrillation who are about to have the left atrial appendage closed through a catheter and cannot take long-term blood thinners because of high bleeding risk.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Non-valvular atrial fibrillation of any type (paroxysmal, permanent or persistent) with a CHA2DS2-VASc score of 2 or more; percutaneous left atrial appendage closure is planned.
- Earlier treatment
- Must not be on clopidogrel at screening. Long-term oral anticoagulant therapy must be judged unsuitable because of bleeding risk, past bleeding or expected poor adherence.
Main reasons for not taking part
- CHA2DS2-VASc score of 0-1
- Heart attack or coronary stent procedure in the last 6 months
- Stroke in the last month or major surgery within one month
- Planned blood thinner (oral anticoagulant) after the procedure
- Pregnant or breast-feeding women
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- Men or women aged =18 years signing a specific informed consent
- Patients with a planned percutaneous LAA closure
- Patients with documented non-valvular AF, irrespective of the type (paroxysmal, permanent, persistent), and CHA2DS2-VASc score =2
- Patients suitable for treatment with aspirin and clopidogrel according to the Summaries of product characteristics (SmPCs)
- Patients considered unsuitable for long-term oral anticoagulant therapy due to a high bleeding risk. Patients will be judged unsuitable for anticoagulation because of bleeding-prone comorbidities, history of previous bleeding (with or without anticoagulant treatment) or an expected low adherence to therapy
- Patient’s availability to undergo the follow-up visits scheduled for the study
- Negative pregnancy testing (if applicable), performed at the time of enrollment
Who cannot take part
- Major surgery within one month
- Fibrinolytic therapy within 10 days
- Requirement for on-going therapy with clopidogrel at the time of screening evaluation (e.g. current therapy with clopidogrel at the time of the screening evaluation will be an exclusion criterion)
- Planned oral anticoagulant therapy after the procedure
- Myocardial infarction or percutaneous coronary intervention <6 months
- Recent stroke (<1 month)
- Known hypersensitivity to the study drugs (aspirin or clopidogrel)
- Patients deemed to be unsuitable for at least 6 months antiplatelet therapy (SAPT or DAPT) because of a recent (<1 month) major bleeding event
- Mechanical heart prosthetic valve
- Active bleeding
- Platelet count <50,000/µL
- Baseline hemoglobin <9 g/dL
- CHADS-VAsc score 0-1
- Intracranial neoplasm, aneurysm or arterio-venous malformation
- Pregnant woman
- Breast-feeding
- Donne fertili impossibilitate ad utilizzare contraccettivi durante lo studio
- Moderate to severe mitral stenosis
- Active endocarditis
Where in Italy
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAncona, ItalyTaking people
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- Ssd Ematologia ASLTO4Chivasso, ItalyTaking people
- Careggi University HospitalFlorence, ItalyTaking people
- Fondazione Toscana Gabriele MonasterioMassa, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Centro Cardiologico Monzino S.p.A.Milan, ItalyTaking people
- Azienda Ospedaliera dei ColliNaples, ItalyTaking people
- Fondazione Evangelica BetaniaNaples, ItalyTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Sanitaria Locale TO3Rivoli, ItalyTaking people
- Azienda Sanitaria Locale Roma 2Rome, ItalyTaking people
- Azienda Ospedaliero-Universitaria di SassariSassari, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
- Azienda Sanitaria Locale VercelliVercelli, ItalyTaking people
About the trial
What the trial wants to find out
To demonstrate that the strategy with single antiplatelet therapy (SAPT) is not inferior to the current standard antiplatelet therapy (DAPT) after LAA closure regarding the cumulative incidence of the net composite endpoint, including death, thrombotic complications and bleeding events, at 6 months.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Head-to-head compaRison of single versus dual antiplatelet treatMent strategY after percutaneous left atrial appenDage closure: A MULticenter, randomizEd sTudy. The ARMYDA-AMULET study
- Plain-language title
- Comparing one blood thinner with two after left atrial appendage closureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 25 September 2026