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Clinical Studies – Targeting Acute and Chronic Thromboembolic Disorders
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A Study of Flexible Dosage in Extended PE/DVT Treatment

Major Studies

 

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 therapy
     

Study Design

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

  • Safety

    • Both 10 mg OD and 20 mg OD Xarelto doses demonstrated a low risk of major bleeding, similar to aspirin

    • Overall rates of major and clinically relevant non-major bleeding were similar between both Xarelto doses and aspirin

 

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

 

PP-XAR-ALL-1816-1

    • 1
      Weitz JI, et al. N Engl J Med. 2017;376:1211–1222.
    • a
      Venous thromboembolism (= VTE). A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism. 
    • b
      Anticoagulant drugs are used to treat and prevent blood clots. Sometimes referred to as ‘blood thinners’. 
    • c
      For VTE extended treatment.
    • d
      Deep vein thrombosis (= DVT). A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal…
    • e
      Pulmonary embolism (= PE). A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.