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Research

Photo for AVERROES

AVERROES

Official Title

Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation
Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment: A
Randomized Double Blind Trial

Status

Completed

Overview

To determine if apixaban 5 mg BID (2.5 mg BID in selected patients) is superior to ASA (81 to 324 mg QD) for preventing the composite outcome of stroke or systemic embolism in patients with atrial fibrillation and at least one additional risk factor for stroke who have failed or are unsuitable for vitamin K antagonist therapy.

Study Design

Randomized, (1:1) double-blind, double-dummy, parallel-arm study assessing apixaban and
ASA. Patients will receive active apixaban tablets and placebo ASA tablets or placebo apixaban tablets and
active ASA tablets.

Primary Endpoint

Composite of stroke or systemic embolism

Number of Patients

5599

Number of Sites

522

Number of Countries

36

Study Period

2007–2010

Principal Investigator

Stuart Connolly, John Eikelboom

Program Manager

Ellison Themeles

Research Coordinator

Gayle Lewis

Key Publications

  • Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O’Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. (2011) N Engl J Med. 364(9):806-17.
  • Eikelboom JW, O’Donnell M, Yusuf S, Diaz R, Flaker G, Hart R Hohnloser S, Joyner C, Lawrence J, Pais P, Pogue J, Synhorst D, Connolly SJ. Rational and Design of Averroes: Apixaban Versus Acetylsalicylic Acid to Prevent Stroke in Atrial Fibrillation Patients who have Failed or are Unsuitable for Vitamin K Antagonist Treatment (2010). Am Heart J 159(3):348-353.
  • Diener HC, Eikelboom J, Connolly SJ, Joyner CD, Hart RG, Lip GY, O’Donnell M, Hohnloser SH, Hankey GJ, Shestakovska O, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban versus aspirin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a predefined subgroup analysis from AVERROES, a randomised trial (2012). Lancet Neurol. 11(3):225-31.
  • Flaker GC, Eikelboom JW, Shestakovska O, Connolly SJ, Kaatz S, Budaj A, Husted S, Yusuf S, Lip GY, Hart RG. Bleeding during treatment with aspirin versus apixaban in patients with atrial fibrillation unsuitable for warfarin: the apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment (AVERROES) trial (2012). Stroke. 43(12):3291-7.
  • Hohnloser SH, Shestakovska O, Eikelboom J, Franzosi MG, Tan RS, Zhu J, Yusuf S, Connolly SJ. The effects of apixaban on hospitalizations in patients with different types of atrial fibrillation: insights from the AVERROES trial (2013). Eur Heart J. 34(35):2752-9.