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)
Key facts
- Where
- Ancona, Bologna, Catania, Chivasso, Florence, Massa, Milan, Naples, Novara, Orbassano, Pisa, Rivoli, Rome, Sassari, Turin és Vercelli, OlaszországSee the 18 sites
- Phase
- 4. fázis
Where in Olaszország
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAncona, OlaszországTaking people
- Azienda Unita Sanitaria Locale Di BolognaBologna, OlaszországTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, OlaszországTaking people
- Ssd Ematologia ASLTO4Chivasso, OlaszországTaking people
- Careggi University HospitalFlorence, OlaszországTaking people
- Fondazione Toscana Gabriele MonasterioMassa, OlaszországTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, OlaszországTaking people
- Centro Cardiologico Monzino S.p.A.Milan, OlaszországTaking people
- Azienda Ospedaliera dei ColliNaples, OlaszországTaking people
- Fondazione Evangelica BetaniaNaples, OlaszországTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, OlaszországTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, OlaszországTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, OlaszországTaking people
- Azienda Sanitaria Locale TO3Rivoli, OlaszországTaking people
- Azienda Sanitaria Locale Roma 2Rome, OlaszországTaking people
- Azienda Ospedaliero-Universitaria di SassariSassari, OlaszországTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, OlaszországTaking people
- Azienda Sanitaria Locale VercelliVercelli, OlaszországTaking people
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?
Trial details
- Who runs it
- Fondazione Toscana Gabriele Monasterio
- Trial code
- EU 2024-515361-34-00
- Record updated
- 2026. szeptember 25.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.