Overview

This trial has been completed.

Conditions pulmonary embolism, thromboembolism, thrombosis, venous thrombosis, venous thromboembolism
Treatments bay 59-7939, asa
Phase phase 3
Sponsor Bayer
Start date March 2014
End date September 2016
Trial size 3396 participants
Trial identifier NCT02064439, 16416

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Rivaroxaban 10 mg once daily for 12 months
bay 59-7939
10 mg tablet once daily for 12 months
(Experimental)
Rivaroxaban 20 mg once daily for 12 months
bay 59-7939
20 mg tablet once daily for 12 months
(Active Comparator)
ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
asa
100 mg tablet once daily for 12 months

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.