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

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ClinicalTrials.gov Identifier: NCT02064439
Recruitment Status : Completed
First Posted : February 17, 2014
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 17, 2014
Results First Submitted Date  ICMJE September 12, 2017
Results First Posted Date  ICMJE December 19, 2017
Last Update Posted Date December 19, 2017
Actual Study Start Date  ICMJE March 5, 2014
Actual Primary Completion Date September 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • Percentage of patients with fatal or non-fatal symptomatic recurrent venous thromboembolism [ Time Frame: Up to 12 months ]
  • Percentage of participants with major bleeding [ Time Frame: Up to 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • Percentage of participants with myocardial infarction, ischemic stroke or systemic non-CNS embolism [ Time Frame: Up to 12 months ]
  • Percentage of participants with Clinically relevant non-major bleeding) [ Time Frame: Up to 12 months ]
  • Percentage of participants with myocardial infarction, ischemic stroke, systemic non-CNS embolism or all cause mortality [ Time Frame: Up to 12 months ]
  • Percentage of participants with major bleeding and recurrent venous thromboembolism [ Time Frame: Up to 12 months ]
  • Percentage of participants with major bleeding, recurrent venous thromboembolism, myocardial infarction, ischemic stroke and systemic non-CNS embolism [ Time Frame: Up to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
Official Title  ICMJE 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
Brief Summary

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pulmonary Embolism
  • Thromboembolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism
Intervention  ICMJE
  • Drug: BAY 59-7939
    10 mg tablet once daily for 12 months
  • Drug: BAY 59-7939
    20 mg tablet once daily for 12 months
  • Drug: ASA
    100 mg tablet once daily for 12 months
Study Arms  ICMJE
  • Experimental: Arm 1
    Rivaroxaban 10 mg once daily for 12 months
    Intervention: Drug: BAY 59-7939
  • Experimental: Arm 2
    Rivaroxaban 20 mg once daily for 12 months
    Intervention: Drug: BAY 59-7939
  • Active Comparator: Arm 3
    ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
    Intervention: Drug: ASA
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2017)
3365
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2014)
2850
Actual Study Completion Date  ICMJE November 4, 2016
Actual Primary Completion Date September 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czechia,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Norway,   Philippines,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States,   Vietnam
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02064439
Other Study ID Numbers  ICMJE 16416
2013-000619-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Janssen Scientific Affairs, LLC
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP