2024-515361-34-00RecruitingPhase 4
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)
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 606 (estimated)
- First submitted
- 1 Aug 2024
- Start date
- 13 Oct 2021
- Lead sponsor
- Fondazione Toscana Gabriele Monasterio
- Diseases
- Atrial fibrillation
- EU CT number
- 2024-515361-34-00
- EudraCT number
- 2021-000730-34
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 606
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Platelet count <50,000/µL
- Baseline hemoglobin <9 g/dL
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi | Ancona | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Di Bologna | Bologna | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania | Catania | Italy | Recruiting |
| Ssd Ematologia ASLTO4 | Chivasso | Italy | Recruiting |
| Careggi University Hospital | Florence | Italy | Recruiting |
| Fondazione Toscana Gabriele Monasterio | Massa | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Recruiting |
| Centro Cardiologico Monzino S.p.A. | Milan | Italy | Recruiting |
| Azienda Ospedaliera dei Colli | Naples | Italy | Recruiting |
| Fondazione Evangelica Betania | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità | Novara | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Recruiting |
| Azienda Sanitaria Locale TO3 | Rivoli | Italy | Recruiting |
| Azienda Sanitaria Locale Roma 2 | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria di Sassari | Sassari | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Turin | Italy | Recruiting |
| Azienda Sanitaria Locale Vercelli | Vercelli | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.