Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)
JPMS-XAR-VTE
2 other identifiers
observational
2,540
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2015
CompletedFirst Posted
Study publicly available on registry
September 24, 2015
CompletedStudy Start
First participant enrolled
November 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedNovember 1, 2022
October 1, 2022
5.4 years
September 23, 2015
October 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Study Arms (1)
Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxavban administration group
Interventions
Treatment parameters following the summary of product characteristics and the physician's decision
Eligibility Criteria
Female and male patients who start rivaroxaban for VTE （pulmonary embolism, deep vein thrombosis) anticoagulation therapy
You may qualify if:
- \- Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.
You may not qualify if:
- \- Patients who are contraindicated based on the product label and have already received Xarelto treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (1)
Many locations
Multiple Locations, Japan
Related Publications (1)
Fukuda I, Hirayama A, Kawasugi K, Kobayashi T, Maeda H, Nakamura M, Yamada N, Tajima T, Tachiiri M, Okayama Y, Sunaya T, Hirano K, Hayasaki T. Safety Profile and Effectiveness of Rivaroxaban for Patients With Venous Thromboembolism in Japan - Results From Post-Marketing Surveillance (XASSENT). Circ J. 2023 Aug 25;87(9):1175-1184. doi: 10.1253/circj.CJ-23-0104. Epub 2023 May 27.
PMID: 37245989DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2015
First Posted
September 24, 2015
Study Start
November 13, 2015
Primary Completion
April 1, 2021
Study Completion
May 31, 2021
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.