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

NCT05554822 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2022-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Left Atrial Appendage Occlusion
  • Antiplatelet Therapy

Interventions

DRUG

Aspirin 100mg

Single antiplatelet therapy with aspirin 100 mg OD for 6 months after the procedure

DRUG

Aspirin 100 mg OD plus clopidogrel 75 mg OD

Double antiplatelet therapy with Aspirin 100 mg OD plus clopidogrel 75 mg OD for 3 months, followed by 3 months of single antiplatelet therapy with aspirin 100 mg OD.

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    lead OTHER

Principal Investigators

  • Giuseppe Patti, MD · University of Eastern Piedmont, Novara - Maggiore della Carità Hospital, Novara

  • Sergio Berti, MD · Fondazione Toscana G. Monasterio, Ospedale del Cuore "G. Pasquinucci"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05554822 on ClinicalTrials.gov