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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515361-34-00

Acronym

ARMYDA-AMULET

Enrollment

606

Registered

2024-09-16

Start date

2021-10-13

Completion date

Unknown

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with atrial fibrillation undergoing percutaneous left atrial appendage closure with the Amulet device

Brief summary

Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3 (7).

Detailed description

DRT at 3 and 6 months by TEE, Any-cause death, Incidence of ischemic stroke or SEE at 3 and 6 months, Incidence of any bleeding at 3 and 6 months, Incidence of BARC classification bleeding ≥3 at 3 and 6 months

Interventions

DRUGPlavix 75 mg film-coated tablets

DRUGCARDIOASPIRIN 100 mg Compresse gastroresistenti

DRUGPlavix 300 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3 (7).	—

Secondary

Measure	Time frame
DRT at 3 and 6 months by TEE, Any-cause death, Incidence of ischemic stroke or SEE at 3 and 6 months, Incidence of any bleeding at 3 and 6 months, Incidence of BARC classification bleeding ≥3 at 3 and 6 months	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026