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

This study has been completed.
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02064439
First received: February 14, 2014
Last updated: January 17, 2017
Last verified: January 2017
  Purpose

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


Condition Intervention Phase
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Drug: BAY 59-7939
Drug: ASA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3396
Study Start Date: March 2014
Study Completion Date: November 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Rivaroxaban 10 mg once daily for 12 months
Drug: BAY 59-7939
10 mg tablet once daily for 12 months
Experimental: Arm 2
Rivaroxaban 20 mg once daily for 12 months
Drug: BAY 59-7939
20 mg tablet once daily for 12 months
Active Comparator: Arm 3
ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
Drug: ASA
100 mg tablet once daily for 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064439

  Show 267 Study Locations
Sponsors and Collaborators
Bayer
Janssen Scientific Affairs, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02064439     History of Changes
Other Study ID Numbers: 16416
2013-000619-26 ( EudraCT Number )
Study First Received: February 14, 2014
Last Updated: January 17, 2017

Keywords provided by Bayer:
deep vein thrombosis
pulmonary embolism
long-term prevention of recurrent symptomatic VTE

Additional relevant MeSH terms:
Venous Thrombosis
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on March 24, 2017