Completed

NCT Number: NCT04923139

A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients 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).

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.

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Key information

Conditions

Treatment of Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Japan databases, Japan Databases, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Dosage at the discretion of the treating physician

Primary outcomes

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.

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

Components of the composite primary outcome: intracranial hemorrhage, intraocular bleeding, upper/lower gastrointestinal bleeding, and bleeding requiring for blood transfusion.
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

PE: Pulmonary Embolism DVT: Deep Vein Thrombosis
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

Patient demographic and clinical characteristics including age, gender, comorbidities, medical history and medication

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Descriptive Analysis of VTE Treatment With Rivaroxaban in Japanese Clinical Practice Using a Claims Database

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 11, 2021
Registry last updated: Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.