check_circleStudy Completed

Treatment of venous thromboembolism in cancer patients,

A study to gather information about rivaroxaban in patients in Sweden with cancer who also have thrombosis (OSCAR-SE)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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

Trial summary

Enrollment Goal
5737
Trial Dates
March 2022 - February 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Swedish registriesMany Locations, Sweden

Primary Outcome

  • Recurrence of VTE
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • Major bleedings
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • All-cause death
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • Choice of anticoagulation treatments for VTE
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • Duration of anticoagulation treatments for VTE
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • Recurrence of VTE with different treatment types of LMWH, VKA and NOAC
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • Major bleedings with different treatment types of LMWH, VKA and NOAC
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • All-cause death with different treatment types of LMWH, VKA and NOAC
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020

Trial design

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A