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

Venous Thromboembolism Clinical Trial

— JPMS-XAR-VTE  

Official title:

Special Drug Use Investigation of Xarelto for VTE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558465
• Other study ID #: 17522
• Secondary ID: XAR-PE-DVT
• Status: Completed
• Start date: November 13, 2015
• Est. completion date: May 31, 2021

Study information

• Verified date: October 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2540
• Est. completion date: May 31, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Treatment parameters following the summary of product characteristics and the physician's decision

Locations

Country	Name	City	State
Japan	Many locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability		Up to 2 years
Primary	Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism)		Up to 2 years
Secondary	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
Secondary	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
Secondary	Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes		Up to 2 years

External Links

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