Skip to main content
OpenTrials
Completed

NCT Number: NCT05150938

A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)

This is an observational study in which patient data from the past on venous thromboembolism (VTE) in patients with cancer is studied.

VTE is a condition in which a patient has problems due to the formation of blood clots in the veins. Blood clots can reduce the flow of blood to vital organs such as the heart and lungs, which can lead to them becoming damaged. VTE can also be "recurrent". This means that the blood clots have returned after treatment. People who have cancer have an increased risk of developing VTE.

Three main types of anticoagulation treatments ("blood thinners") have been available for patients with cancer who also have VTE

* Low molecular weight heparins (LMWHs) * Vitamin K antagonists (VKAs) * Non-vitamin K antagonist oral anticoagulants (NOACs) The treatment rivaroxaban belongs to the NOACs.

Compared to other treatments available to patients who have cancer and VTE, NOACs may cause fewer medical problems and can be easier for patients to take correctly.

In this study, the researchers will collect data about:

* the type of VTE treatments given and for how long the treatments are taken * the risk of blood clots returning in the veins after treatment, any events of major bleeding, and the number of deaths in patients with cancer who do not have a high risk of bleeding

The researchers will compare this information in the patients

* who received rivaroxaban to the patients who received LMWHs * who received NOACs to the patients who received LMWHs.

There will be no required visits with a study doctor or required tests in this study. The researchers will look at the health information from adult patients in Sweden who were diagnosed with cancer between 2013 and 2019 and also have VTE. The researchers will collect this information from Swedish health registers including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Treatment of Venous Thromboembolism in Cancer Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swedish registries

Multiple Locations, Many Locations, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A resident in Sweden of 18+ years of age
  • A Swedish Person Identification Number
  • A diagnosis of cancer ((ICD10 = C00-C97) in the Swedish Cancer registry during 2013-2019 and a diagnosis of VTE subsequent to the cancer diagnosis.

Exclusion criteria

  • A diagnosis of atrial fibrillation, total hip or knee replacement or acute coronary syndrome (for evaluation of treatment patterns) before the date of VTE diagnosis
  • A dispensed prescription for any oral anticoagulant (OAC) before the date of VTE diagnosis
  • A cancer diagnosis associated with high bleeding risk, including upper gastrointestinal cancer, malignant immunoproliferative diseases and leukemia

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.

Low Molecular Weight Heparin (LMWH)

Drug

Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.

Vitamin K antagonist (VKA)

Drug

Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.

other NOACs

Drug

Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.

Primary outcomes

  1. Recurrence of VTE

    Time frame: Retrospective data analysis from 2013 to 2020

  2. Major bleedings

    Time frame: Retrospective data analysis from 2013 to 2020

  3. All-cause death

    Time frame: Retrospective data analysis from 2013 to 2020

  4. Choice of anticoagulation treatments for VTE

    Time frame: Retrospective data analysis from 2013 to 2020

  5. Duration of anticoagulation treatments for VTE

    Time frame: Retrospective data analysis from 2013 to 2020

  6. Recurrence of VTE with different treatment types of LMWH, VKA and NOAC

    Time frame: Retrospective data analysis from 2013 to 2020

  7. Major bleedings with different treatment types of LMWH, VKA and NOAC

    Time frame: Retrospective data analysis from 2013 to 2020

  8. All-cause death with different treatment types of LMWH, VKA and NOAC

    Time frame: Retrospective data analysis from 2013 to 2020

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2021
Registry last updated
Dec 18, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.