Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders

A Study of Flexible Dosage in Extended PE/DVT Treatment

EINSTEIN CHOICE:
A Study of Xarelto® with a Flexible Choice of Dosage for Extended Treatment of Recurrent VTE

Objective

  • To compare the efficacy and safety profile of 20 mg OD or 10 mg OD Xarelto doses with aspirin for extended treatment of recurrent VTE , in patients who had been treated for 6–12 months with an anticoagulant therapy1

Study Design

  • EINSTEIN CHOICE is a randomised, double-blind, active-controlled, event-driven, superiority, Phase 3 study1
  • The primary efficacy outcome was symptomatic, recurrent, fatal or non-fatal VTE , and the principal safety outcome was major bleeding1
einstein choice study design

* ≤7 days of treatment interruption prior to randomisation. † Patients randomised after the requisite number of primary efficacy outcomes was reached were treated for ≥6 months.

Patients’ Clinical Characteristics

einstein-choice-patients-clinical-characteristics

Key Findings

  • Efficacy
    • Both 10 mg OD and 20 mg OD Xarelto doses significantly reduced the risk of recurrent VTE vs aspirin‡,1
  • Safety
    • Both 10 mg OD and 20 mg OD Xarelto doses demonstrated a low risk of major bleeding, similar to aspirin‡,1
    • Overall rates of major and clinically relevant non-major bleeding were similar between both Xarelto doses and aspirin‡,1

DVT , deep vein thrombosis ; OD, once daily; PE , pulmonary embolism; VTE , venous thromboembolism.
‡ For VTE extended treatment.

 

PP-XAR-ALL-1816-1

References