Trial Condition(s):
Venous Thromboembolism
Special Drug Use Investigation of Xarelto for Venous thromboembolism (VTE) (JPMS-XAR-VTE)
Bayer Identifier:
17522
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Special Drug Use Investigation of Xarelto for VTE
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerabilityTimeframe: Up to 2 years
- Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism)Timeframe: Up to 2 years
Secondary Outcome
- 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/ADRsTimeframe: 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 periodTimeframe: at 1 year
- Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomesTimeframe: Up to 2 years
Additional Information
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