Treatment of Venous ThromboembolismNCT04923139
A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients Using a Claims Database
An observational study of Treatment of Venous Thromboembolism, run by Bayer at 2 sites in Japan.
Trial summary
This is an observational study in which data from the past is collected for a treatment which is already available for doctors to prescribe for venous thromboembolism (VTE). VTE is a condition in which blood clots form in veins, which can lead to disability and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Venous Thromboembolism
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- How many people
- 2,627 participants
- Where
- 2 sitesJapan
- Study dates
- 24 Jan 2022to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients from the Medical Data Vision Co., Ltd (MDV) extracted sample that satisfy all of the inclusion and none of the exclusion criteria will be included
Who may be able to join
- Having a diagnosis of VTE recorded during the selection period (01-Apr-2016 to 31-May-2020 inclusive),
- Having a rivaroxaban prescription claim within 30 days after the VTE diagnosis ,
- Being age 18 years or older at the index date,
- Having at least 180 days baseline period.
Who cannot join
- Having evidence of atrial fibrillation, atrial flutter, dialysis, CTEPH (Chronic Thromboembolic Pulmonary Hypertension) or pregnancy during the baseline period,
- Having a claim of rivaroxaban during the baseline period.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Descriptive Analysis of VTE Treatment With Rivaroxaban in Japanese Clinical Practice Using a Claims Database
This is an observational study in which data from the past is collected for a treatment which is already available for doctors to prescribe for venous thromboembolism (VTE). VTE is a condition in which blood clots form in veins, which can lead to disability and death. This study looks at the bleeding risk in Japanese patients who are already receiving long-term rivaroxaban treatment for their VTE.
Some common causes of VTE are surgery, lack of movement, being bed-ridden and cancer. VTE that is caused by cancer is called cancer-associated venous thromboembolism (Ca-VTE).
Read more
The study treatment, rivaroxaban, is a blood thinner prescribed by doctors to help treat conditions like VTE. By thinning the blood, rivaroxaban can help keep blood flowing normally and prevent blood clots. But, rivaroxaban can lead to increased bleeding in some people.
There have been studies done in which participants with VTE and Ca-VTE received treatment with rivaroxaban for a long period of time. The overall results of those studies showed that long-term treatment with rivaroxaban helped prevent blood clots in those participants. Some of the participants had increased bleeding after this long-term treatment, while some did not. Participants with certain types of cancers, such as Ca-VTE, also had an increased risk of bleeding.
These studies, however, did not include Japanese participants. So, the researchers in this study want to learn more about the risk of bleeding in Japanese patients with VTE or Ca-VTE who receive long-term treatment with rivaroxaban. To do this, the researchers plan to use a medical database to find information for patients with VTE and Ca-VTE who have already been taking rivaroxaban for their condition. This database will help the researchers collect information about the bleeding risk of long-term rivaroxaban treatment in Japanese patients.
In this study, the researchers will learn more about:
- the characteristics of patients with VTE who are treated with rivaroxaban for a period of less than 3 months to more than 1 year
- the bleeding risk for all of the patients throughout the study
- the bleeding risk for the patients with Ca-VTE throughout the study
- the cause of any bleeding that happens
The researchers will follow and record these results for Japanese patients from October 2015 to December 2020.
- Conditions
- Treatment of Venous Thromboembolism
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Dosage at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Japanese VTE patients including Ca-VTE patients | Include a large number of adult VTE patients (including Ca-VTE patients) prescribed rivaroxaban who visited facilities covered by the MDV database Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive summary of bleeding risk profile of rivaroxaban, e.g.: incidence rate of / time to bleeding
A bleeding defined as a composite of intracranial hemorrhage, intraocular bleeding, upper/lower gastrointestinal bleeding, and bleeding requiring for blood transfusion.
Measured: Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020
Secondary outcomes (3)
Descriptive summary of individual components of the composite primary outcome. e.g.: incidence rate of / time to each individual components of the composite primary outcome
Components of the composite primary outcome: intracranial hemorrhage, intraocular bleeding, upper/lower gastrointestinal bleeding, and bleeding requiring for blood transfusion.
Measured: Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020
Descriptive summary of recurrent PE/DVT event. e.g.: incidence rate of / time to recurrent PE/DVT
PE: Pulmonary Embolism DVT: Deep Vein Thrombosis
Measured: Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020
Descriptive summary of VTE patient characteristics that treated with Rivaroxaban
Patient demographic and clinical characteristics including age, gender, comorbidities, medical history and medication
Measured: Retrospective analysis from baseline period [180 days before index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis)] up to 31-Dec-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start24 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of 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
- Retrospective
- Enrolment
- 2,627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923139
- Sponsor's protocol ID
- 21471
- Status last verified
- Jan 2023
- First submitted
- 4 Jun 2021
- Last updated
- 12 Jan 2023
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Analysis of VTE Treatment With Rivaroxaban in Japanese Clinical Practice Using a Claims Database
- ClinicalTrials.gov ID
- NCT04923139
- Acronym / sponsor ID
- 21471
- Conditions
- Treatment of Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,627 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Jun 2021 (actual)
- 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.
This is an observational study in which data from the past is collected for a treatment which is already available for doctors to prescribe for venous thromboembolism (VTE). VTE is a condition in which blood clots form in veins, which can lead to disability and death. This study looks at the bleeding risk in Japanese patients who are already receiving long-term rivaroxaban treatment for their VTE.
Some common causes of VTE are surgery, lack of movement, being bed-ridden and cancer. VTE that is caused by cancer is called cancer-associated venous thromboembolism (Ca-VTE).
The study treatment, rivaroxaban, is a blood thinner prescribed by doctors to help treat conditions like VTE. By thinning the blood, rivaroxaban can help keep blood flowing normally and prevent blood clots. But, rivaroxaban can lead to increased bleeding in some people.
There have been studies done in which participants with VTE and Ca-VTE received treatment with rivaroxaban for a long period of time. The overall results of those studies showed that long-term treatment with rivaroxaban helped prevent blood clots in those participants. Some of the participants had increased bleeding after this long-term treatment, while some did not. Participants with certain types of cancers, such as Ca-VTE, also had an increased risk of bleeding.
These studies, however, did not include Japanese participants. So, the researchers in this study want to learn more about the risk of bleeding in Japanese patients with VTE or Ca-VTE who receive long-term treatment with rivaroxaban. To do this, the researchers plan to use a medical database to find information for patients with VTE and Ca-VTE who have already been taking rivaroxaban for their condition. This database will help the researchers collect information about the bleeding risk of long-term rivaroxaban treatment in Japanese patients.
In this study, the researchers will learn more about:
- the characteristics of patients with VTE who are treated with rivaroxaban for a period of less than 3 months to more than 1 year
- the bleeding risk for all of the patients throughout the study
- the bleeding risk for the patients with Ca-VTE throughout the study
- the cause of any bleeding that happens
The researchers will follow and record these results for Japanese patients from October 2015 to December 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Japanese VTE patients including Ca-VTE patients | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)Include a large number of adult VTE patients (including Ca-VTE patients) prescribed rivaroxaban who visited facilities covered by the MDV database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients from the Medical Data Vision Co., Ltd (MDV) extracted sample that satisfy all of the inclusion and none of the exclusion criteria will be included
Key inclusion criteria (4 listed)
- Having a diagnosis of VTE recorded during the selection period (01-Apr-2016 to 31-May-2020 inclusive),
- Having a rivaroxaban prescription claim within 30 days after the VTE diagnosis ,
- Being age 18 years or older at the index date,
- Having at least 180 days baseline period.
Key exclusion criteria (2 listed)
- Having evidence of atrial fibrillation, atrial flutter, dialysis, CTEPH (Chronic Thromboembolic Pulmonary Hypertension) or pregnancy during the baseline period,
- Having a claim of rivaroxaban during the baseline period.
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)Dosage at the discretion of the treating physician | Drug | Japanese VTE patients including Ca-VTE patients |
Primary outcome
Descriptive summary of bleeding risk profile of rivaroxaban, e.g.: incidence rate of / time to bleeding
Time frame: Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020
A bleeding defined as a composite of intracranial hemorrhage, intraocular bleeding, upper/lower gastrointestinal bleeding, and bleeding requiring for blood transfusion.
3 secondary outcomes
Descriptive summary of individual components of the composite primary outcome. e.g.: incidence rate of / time to each individual components of the composite primary outcome
Time frame: Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020
Descriptive summary of recurrent PE/DVT event. e.g.: incidence rate of / time to recurrent PE/DVT
Time frame: Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020
Descriptive summary of VTE patient characteristics that treated with Rivaroxaban
Time frame: Retrospective analysis from baseline period [180 days before index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis)] up to 31-Dec-2020
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 12 Jan 2023.
- 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.clinicalstudydatarequest.com 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 Study sponsors 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment of Venous Thromboembolism, run by Bayer at 2 sites 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 4 inclusion and 2 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Descriptive summary of bleeding risk profile of rivaroxaban, e.g.: incidence rate of / time to bleeding (time frame: Retrospective analysis from index date (first VTE diagnosis having a rivaroxaban prescription claim within 30-days after the diagnosis) up to 31-Dec-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2023.