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

Phase 3

Completed

• Conditions: Thromboembolism; Pulmonary Embolism; Thrombosis; Venous Thrombosis; Venous Thromboembolism
• Interventions: Drug: BAY 59-7939; Drug: ASA

• Registration Number: NCT02064439
• Lead Sponsor: Bayer

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-03-05
• Primary Completion: 2016-09-22
• Study Completion: 2016-11-04
• Results First Submitted: 2017-09-12
• Status Verified: 2017-11
• Results First Submitted QC: 2017-12-17
• Last Update Submitted: 2017-12-17
• Results First Posted: 2017-12-19
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3365

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	BAY 59-7939	Rivaroxaban 10 mg once daily for 12 months
Arm 2	BAY 59-7939	Rivaroxaban 20 mg once daily for 12 months
Arm 3	ASA	ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months

Primary Outcome Measures

Name	Time	Method
Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism	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	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 Outcome Measures

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