Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923139
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2021-06-04
Brief Title:
A Study to Learn About Venous Thromboembolism VTE Treatment With Rivaroxaban in Japanese Patients Using a Claims Database
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Descriptive Analysis of VTE Treatment With Rivaroxaban in Japanese Clinical Practice Using a Claims Database
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None