JPMS-XAR-VTE: Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT02558465
Collaborator
Janssen Research & Development, LLC (Industry)
2,540
1
66.6
38.2
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
2540 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Special Drug Use Investigation of Xarelto for VTE
Actual Study Start Date
:
Nov 13, 2015
Actual Primary Completion Date
:
Apr 1, 2021
Actual Study Completion Date
:
May 31, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) Rivaroxavban administration group |
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Treatment parameters following the summary of product characteristics and the physician's decision
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many locations | Multiple Locations | Japan |
Sponsors and Collaborators
- Bayer
- Janssen Research & Development, LLC
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT02558465
Other Study ID Numbers:
- 17522
- XAR-PE-DVT
First Posted:
Sep 24, 2015
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bayer
Additional relevant MeSH terms: