Comparison Of Idraparinux With Vitamin K Antagonists For Prevention Of Thromboembolism In Patients With Atrial Fibrillation

About AMADEUS study

The phase III AMADEUS study was a randomised, open label trial designed to  compare the efficacy and safety of once-a-week idraparinux versus oral VKA treatment for the long-term prevention of thromboembolic  events (stroke and non-central nervous system systemic embolism) in  patients with AF and at least one additional risk factor for stroke. The predefined risk factors were previous ischemic stroke, transient ischemic attack or SE, hypertension  requiring drug treatment, left ventricular dysfunction, age >75  years, age between 65-75 years plus diabetes mellitus, or age between  65-75 years plus symptomatic coronary heart disease.

4,576 patients (2,283 in the idraparinux group and 2,293 in the VKA group) have been randomized between September 2003 and July 2005.

Patients with AF who were eligible for VKA treatment were randomized to receive either subcutaneous idraparinux 2.5 mg once a week  or VKA therapy adjusted to achieve the target international normalized  ratio (INR) of 2.5 (range 2 to 3). The study was powered to show non-inferior efficacy of idraparinux, compared with standard vitamin K antagonist (VKA) treatment  in patients with AF who require prolonged oral anticoagulation. The primary efficacy endpoint was the composite of all strokes (ischemic,  hemorrhagic and undefined) and non-CNS SE within the planned treatment period. The principal safety endpoint was the occurrence of major bleeding or clinically relevant non-major  bleeding. The other safety outcome was all cause mortality.

About BOREALIS-AF study

BOREALIS-AF is a multicenter, randomized, double-blind, assessor-blind,  non-inferiority study comparing the efficacy and safety of once-a-week  subcutaneous biotinylated idraparinux with adjusted-dose warfarin in the prevention  of stroke and systemic thromboembolic events in patients with atrial  fibrillation.

Treatment will be administrated for a period of 6 months to 2 years. All patients will start with biotinylated idraparinux 3 mg (equivalent to base  idraparinux 2.5 mg) once-a-week for 7 weeks, and then the dose will be  reduced depending on age and renal function.

About idraparinux

Idraparinux sodium is a novel long-acting synthetic highly potent synthetic and  specific indirect inhibitor of coagulation factor Xa, injectable  subcutaneously. Its long-duration of action makes it suitable for weekly administration.