Venous ThromboembolismJPMS-XAR-VTENCT02558465
Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)
An observational study of Venous Thromboembolism, run by Bayer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- How many people
- 2,540 participants
- Where
- 1 siteJapan
- Study dates
- 13 Nov 2015to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female and male patients who start rivaroxaban for VTE （pulmonary embolism, deep vein thrombosis) anticoagulation therapy
Who may be able to join
- Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.
Who cannot join
- Patients who are contraindicated based on the product label and have already received Xarelto treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Drug Use Investigation of Xarelto for VTE
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).
- Conditions
- Venous Thromboembolism
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Keywords
- Xarelto, rivaroxaban, VTE, PE, DVT, Japan, PMS, SDUI
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Treatment parameters following the summary of product characteristics and the physician's decision
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Rivaroxavban administration group Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeding as a measure of Safety and tolerability
Measured: Up to 2 years
Number of participants with symptomatic recurrent VTE (composite of DVT or nonfatal or fatal pulmonary embolism)
Measured: 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
Measured: 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
Measured: at 1 year
Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start13 Nov 2015
- Primary completion1 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558465
- Sponsor's protocol ID
- 17522
- Other IDs
- XAR-PE-DVT
- Acronym
- JPMS-XAR-VTE
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2015
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37245989
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation of Xarelto for VTE
- ClinicalTrials.gov ID
- NCT02558465
- Acronym / sponsor ID
- JPMS-XAR-VTE / 17522
- Conditions
- Venous Thromboembolism
- Keywords
- Xarelto, rivaroxaban, VTE, PE, DVT, Japan, PMS, SDUI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,540 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Rivaroxavban administration group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female and male patients who start rivaroxaban for VTE （pulmonary embolism, deep vein thrombosis) anticoagulation therapy
Key inclusion criteria (1 listed)
- Patients who start rivaroxaban for VTE(pulmonary embolism, deep vein thrombosis) anticoagulation therapy.
Key exclusion criteria (1 listed)
- Patients who are contraindicated based on the product label and have already received Xarelto treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)Treatment parameters following the summary of product characteristics and the physician's decision | Drug | Rivaroxaban (Xarelto, BAY59-7939) |
Primary outcome
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
3 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
Time frame: 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
Time frame: at 1 year
Frequency of VTE recurrence and adverse events/ADRs comparison between distal and/or proximal DVT localization treatment outcomes
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 37245989Fukuda 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02558465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.