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Completed

NCT Number: NCT02064439

Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)

This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.

Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Garran, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week

Exclusion criteria

  • Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance < 30 mL/min

Treatment and study plan

BAY 59-7939

Drug

10 mg tablet once daily for 12 months

ASA

Drug

100 mg tablet once daily for 12 months

Primary outcomes

  1. Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism

    Time frame: Up to 12 months, at least 6 months

    The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment.

    Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

  2. Number of Participants With First Treatment-emergent Major Bleeding

    Time frame: Up to 12 months, at least 6 months

    The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.

    Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

Secondary outcomes

  1. Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism

    Time frame: Up to 12 months, at least 6 months

    The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

  2. Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days

    Time frame: Up to 12 months, at least 6 months

    The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism

Acronym: EinsteinChoice

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2014
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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