NCT05554822: ARMYDA-AMULET

Head-to-head Comparison of Single Versus Dual Antiplatelet Treatment Strategy After Percutaneous Left Atrial Appendage Closure: a Multicenter, Randomized Study

Status unknown Phase 3 Last updated 3 October 2022

What this trial tests

Phase 3 trial testing Aspirin 100mg in Left Atrial Appendage Occlusion in 574 participants. Status unknown.

Timeline

14 June 2021

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Azienda Ospedaliero Universitaria Maggiore della Carita
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	574
Start date	14 June 2021
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	19 locations across Italy

Drugs / interventions tested

• Aspirin 100mg — full drug profile →
• Aspirin 100 mg OD plus clopidogrel 75 mg OD — full drug profile →

Conditions studied

• Left Atrial Appendage Occlusion — all drugs for Left Atrial Appendage Occlusion →
• Antiplatelet Therapy — all drugs for Antiplatelet Therapy →

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita — full company profile →

Who can join

18 and older, any sex, with Left Atrial Appendage Occlusion or Antiplatelet Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US) in patients with AF. Primary outcome measure will be a net composite endpoint at 6 months including all-cause death, DRT, clinically relevant bleeding complications and ischemic events. The SAPT arm will receive aspirin alone up to 6 months, while the DAPT arm will receive DAPT for 3 months and then aspirin alone. Thus, between 3- and 6-month follow-up both groups will be given aspirin alone.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Single antiplatelet therapy following Amplatzer left atrial appendage occlusion.
   Kramer A, Korsholm K, Nielsen-Kudsk JE. · · 2024 · cited 6× · PMID 38436367 · DOI 10.4244/eij-d-23-00684
2. Left Atrial Appendage Occlusion and Post-procedural Antithrombotic Management.
   Kramer A, Patti G, Nielsen-Kudsk JE, Berti S, et al · · 2024 · cited 4× · PMID 38337496 · DOI 10.3390/jcm13030803