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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

Next steps

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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (18)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAnconaItalyRecruiting
Azienda Unita Sanitaria Locale Di BolognaBolognaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCataniaItalyRecruiting
Ssd Ematologia ASLTO4ChivassoItalyRecruiting
Careggi University HospitalFlorenceItalyRecruiting
Fondazione Toscana Gabriele MonasterioMassaItalyRecruiting
ASST Grande Ospedale Metropolitano NiguardaMilanItalyRecruiting
Centro Cardiologico Monzino S.p.A.MilanItalyRecruiting
Azienda Ospedaliera dei ColliNaplesItalyRecruiting
Fondazione Evangelica BetaniaNaplesItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della CaritàNovaraItalyRecruiting
Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassanoItalyRecruiting
Azienda Ospedaliero Universitaria PisanaPisaItalyRecruiting
Azienda Sanitaria Locale TO3RivoliItalyRecruiting
Azienda Sanitaria Locale Roma 2RomeItalyRecruiting
Azienda Ospedaliero-Universitaria di SassariSassariItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano di TorinoTurinItalyRecruiting
Azienda Sanitaria Locale VercelliVercelliItalyRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.