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Completed

NCT Number: NCT02558465

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

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).

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Treatment parameters following the summary of product characteristics and the physician's decision

Primary outcomes

  1. Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability

    Time frame: Up to 2 years

  2. Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism)

    Time frame: Up to 2 years

Secondary outcomes

  1. 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

    Time frame: Up to 2 years

  2. 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

    Time frame: at 1 year

  3. Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Special Drug Use Investigation of Xarelto for VTE

Acronym: JPMS-XAR-VTE

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2015
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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