Research > Arrhythmia & Thrombosis

ARTESiA

Official Title

Apixaban for the Reduction of Thrombo-Embolism in Patients with Device-Detected Sub-Clinical Atrial Fibrillation

Status

Ongoing

Overview

To determine if treatment with apixaban, compared with aspirin, will reduce the risk of stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation (SCAF) and additional risk factors for stroke. Current guidelines recommend treatment with oral anticoagulant for stroke prevention in clinical AF but opinion leaders are uncertain of the role of oral anticoagulants for patients with SCAF. 4000 patients from approximately 240 sites in Canada, USA and Europe will be randomized double-blind to receive apixaban (5mg bid or 2.5 mg bid as per labelling) or aspirin (81mg OD). The study will be event driven and will continue until 248 patients have experienced a primary outcome event (stroke or systemic embolism). Estimated mean follow-up time is 3 years.

Study Design

Randomized, double-blind trial, Phase IV, multicentre, prospective, parallel group design.

Primary Endpoint

Composite of stroke and systemic embolism

Number of Patients

4000

Number of Sites

240

Number of Countries

Study Period

2015–2021

Principal Investigator

Jeff Healey, Marco Alings, Renato Lopes

Program Manager

Heather Beresh

Research Coordinator

Kim Simek

Collaborators

BMS/Pfizer, Medtronic

Emergency Unblinding

If knowing the allocation would alter the course of treatment in an emergency situation, medical staff in the patient’s circle of care should contact the local Investigator listed on the patient’s emergency contact card. If the Investigator is unavailable, they can call the emergency unblinding number; 905-522-3288.