Clinical trial NCT05150938: A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)
Official title: Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment of Venous Thromboembolism in Cancer Patients
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2021-12-09
Enrollment: 5737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with cancer in Sweden from year 2013 to 2019.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of VTE
timeFrame: Retrospective data analysis from 2013 to 2020
measure: Major bleedings
timeFrame: Retrospective data analysis from 2013 to 2020
measure: All-cause death
timeFrame: Retrospective data analysis from 2013 to 2020
measure: Choice of anticoagulation treatments for VTE
timeFrame: Retrospective data analysis from 2013 to 2020
measure: Duration of anticoagulation treatments for VTE
timeFrame: Retrospective data analysis from 2013 to 2020
measure: Recurrence of VTE with different treatment types of LMWH, VKA and NOAC
timeFrame: Retrospective data analysis from 2013 to 2020
measure: Major bleedings with different treatment types of LMWH, VKA and NOAC
timeFrame: Retrospective data analysis from 2013 to 2020
measure: All-cause death with different treatment types of LMWH, VKA and NOAC
timeFrame: Retrospective data analysis from 2013 to 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Sweden
facility: Swedish registries
state: Many Locations
Study officials:
References: