A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)
NCT ID: NCT05150938
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5737 participants
OBSERVATIONAL
2022-03-18
2023-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cancer patients with VTE
Cancer patients who received anticoagulation treatment.
Rivaroxaban (Xarelto, BAY59-7939)
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)
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)
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
other NOACs
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
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)
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)
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
other NOACs
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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Swedish registries
Multiple Locations, Many Locations, Sweden
Countries
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References
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Linder M, Ekbom A, Brobert G, Vogtlander K, Balabanova Y, Becattini C, Carrier M, Cohen AT, Coleman CI, Khorana AA, Lee AYY, Psaroudakis G, Abdelgawwad K, Rivera M, Schaefer B, Giunta DH. Comparison of rivaroxaban and low molecular weight heparin in the treatment of cancer-associated venous thromboembolism: a Swedish national population-based register study. J Thromb Thrombolysis. 2024 Aug;57(6):973-983. doi: 10.1007/s11239-024-02992-1. Epub 2024 May 12.
Related Links
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Other Identifiers
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21616
Identifier Type: -
Identifier Source: org_study_id