The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)

Last updated: April 2, 2025
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vascular Diseases

Heart Valve Disease

Treatment

Dabigatran

Apixaban

Warfarin

Clinical Study ID

NCT06449469
2020-003361-19
2020-003361-19
  • Ages > 18
  • All Genders

Study Summary

A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies. Additionally, this study aims to examine a possible association between HALT and thromboembolic events.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who underwent successful TAVI according to Valve Academic ResearchConsortium (VARC)-2 criteria

  • Residing in Denmark

  • Provided written informed consent

Exclusion

Exclusion Criteria:

  • Atrial fibrillation or any other indication for lifelong oral anticoagulant therapy

  • Patient deemed not suitable for DOAC treatment because of previous life-threateningor major bleeding, e.g. intracranial haemorrhage or major gastrointestinal bleeding

  • Patients with severe renal insufficiency (eGFR <30 mL/min/1.73 m2)

  • Patient with absolute indication for anti-thrombotic therapy, e.g. recent PCI

  • Iodine contrast allergy or other condition that prohibits CT imaging

  • Age <18 years

  • Women of childbearing potential, pregnant or nursing

Study Design

Total Participants: 352
Treatment Group(s): 7
Primary Treatment: Dabigatran
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
April 01, 2030

Study Description

The NOTION-4 trial is an investigator-initiated, randomized, open label, comparative trial conducted at Rigshospitalet in Copenhagen and Skejby Sygehus in Aarhus. All adult patients that have undergone successful TAVI without contraindications for cardiac CT will be invited to participate in this study. Patients with SR and without known other indication for chronic OAC therapy will be randomized 1:1 either to lifelong ASA or to 3 months of DOAC followed by lifelong ASA. Patients with known AF will be randomized 1:1 to lifelong DOAC versus LAAC within 3 months followed by lifelong ASA.

Connect with a study center

  • Aarhus University Hospital, Skejby

    Aarhus,
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

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