Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT02558465
• Lead Sponsor: Bayer

Brief Summary

The objective of this investigation is to assess safety and effectiveness of Xarelto under practice routine use in VTE secondary prevention after acute DVT, focusing on hemorrhagic-related AEs, recurrent venous thromboembolism (PE/DVT), all-cause mortality. This study is a company sponsored, one- arm prospective cohort study with patients to whom Rivaroxaban treatment for VTE (PE/DVT) has been chosen. The study includes a standard observation period (1 year) and an extension survey period (2 years, at the longest).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Study Start: 2015-11-13
• Primary Completion: 2021-04-01
• Study Completion: 2021-05-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-30
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2540

Inclusion Criteria

• Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.

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Exclusion Criteria

• Patients who are contraindicated based on the product label and have already received Xarelto treatment.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939)	Rivaroxavban administration group

Primary Outcome Measures

Name	Time	Method
Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability	Up to 2 years
Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Composite number of all-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack, or systemic embolism), clinically relevant non-major bleeding and all other adverse events/ADRs	Up to 2 years
Number of participants with asymptomatic deterioration of thrombotic burden (change of D-dimer, imaging test such as CT or CCUS) by the end of standard observation period	at 1 year
Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes	Up to 2 years

Trial Locations

Locations (1)

Many locations; 🇯🇵 Multiple Locations, Japan