Venous Thromboembolism
Conditions
Keywords
Xarelto, rivaroxaban, VTE, PE, DVT, Japan, PMS, SDUI
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).
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
Treatment parameters following the summary of product characteristics and the physician's decision
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed