ARISTOTLE Clinical Trial

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ELIQUIS^® offers superior reductions in the rates of stroke / systemic embolism AND major bleeding vs. warfarin, PLUS a significant reduction in all-cause mortality.¹

In patients with NVAF, ELIQUIS demonstrated:¹

Superior risk reduction in stroke / systemic embolism vs. warfarin^1*

Superior risk reduction in major bleeding vs. warfarin^1*

Significant risk reduction in all-cause mortality vs. warfarin1^1*

ELIQUIS (apixaban) is indicated for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA), age ≥75 years, hypertension, diabetes mellitus, symptomatic heart failure (NYHA Class ≥II); treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults; and, prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery.²

Footnotes:

^*The ARISTOTLE clinical trial was a randomised, double-blind, double-dummy, non-inferiority trial in 18,201 patients with NVAF. Stroke / systemic embolism, including haemorrhagic, ischaemic or undetermined stroke, was the primary efficacy endpoint, major bleeding according to ISTH criteria was the primary safety outcome and all-cause mortality was a key secondary endpoint.¹ Pre-specified hierarchical sequential testing was performed first on stroke / systemic embolism (primary efficacy endpoint) for non-inferiority, then for superiority, then on major bleeding, and finally, on death from any cause (secondary endpoint).¹ The median duration of follow-up was 1.8 years.¹
^†This link is to a third-party site unaffiliated with the Pfizer / BMS Alliance. Please abide by the terms of use of the site. https://www.nejm.org/doi/pdf/10.1056/NEJMoa1107039

ARR = Absolute Risk Reduction CI = Confidence Interval HR = Hazard Ratio ISTH = International Society on Thrombosis and Haemostasis N = Total number of patients in either the ELIQUIS group or the warfarin group n = Number of patients with event NVAF = Non-Valvular Atrial Fibrillation RRR = Relative Risk Reduction

References:

Granger CB et al. N Engl J Med 2011; 365: 981–992
ELIQUIS^® (apixaban) Summary of Product Characteristics.

Date of Preparation: September 2025 | Job Description: 432-IE-2500025