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

Rigshospitalet

Status

Active, not recruiting

Conditions

Heart Valve Diseases

Aortic Valve Stenosis

Cardiovascular Diseases

Valve Disease, Aortic

Heart Diseases

Treatments

Drug: Dabigatran

Drug: Apixaban

Drug: Edoxaban

Drug: Acetylsalicylic acid

Drug: Clopidogrel

Drug: Rivaroxaban

Drug: Warfarin

Study type

Interventional

Funder types

Other

Identifiers

NCT06449469

2020-003361-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

352 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who underwent successful TAVI according to Valve Academic Research Consortium (VARC)-2 criteria
Residing in Denmark
Provided written informed consent

Exclusion criteria

Atrial fibrillation or any other indication for lifelong oral anticoagulant therapy
Patient deemed not suitable for DOAC treatment because of previous life-threatening or 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

352 participants in 2 patient groups

Sinus rhythm - DOAC treatment

Experimental group

Description:

Can either of the following anti-platelet components: dabigatran, apixaban, rivaroxaban, edoxaban or warfarin. Duration: 3 months, followed by an anti-platelet hereafter.

Treatment: