Special Drug Use Investigation of Xarelto for VTE
Overview
- Phase
- Not Applicable
- Intervention
- Rivaroxaban (Xarelto, BAY59-7939)
- Conditions
- Venous Thromboembolism
- Sponsor
- Bayer
- Enrollment
- 2540
- Locations
- 1
- Primary Endpoint
- Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
Investigators
Eligibility Criteria
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.
Arms & Interventions
Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxavban administration group
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Outcomes
Primary Outcomes
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
Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism)
Time Frame: Up to 2 years
Secondary Outcomes
- 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)