A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)
1 other identifier
observational
5,737
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedStudy Start
First participant enrolled
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedDecember 18, 2023
December 1, 2023
12 months
November 18, 2021
December 12, 2023
Conditions
Outcome Measures
Primary Outcomes (8)
Recurrence of VTE
Retrospective data analysis from 2013 to 2020
Major bleedings
Retrospective data analysis from 2013 to 2020
All-cause death
Retrospective data analysis from 2013 to 2020
Choice of anticoagulation treatments for VTE
Retrospective data analysis from 2013 to 2020
Duration of anticoagulation treatments for VTE
Retrospective data analysis from 2013 to 2020
Recurrence of VTE with different treatment types of LMWH, VKA and NOAC
Retrospective data analysis from 2013 to 2020
Major bleedings with different treatment types of LMWH, VKA and NOAC
Retrospective data analysis from 2013 to 2020
All-cause death with different treatment types of LMWH, VKA and NOAC
Retrospective data analysis from 2013 to 2020
Study Arms (1)
Cancer patients with VTE
Cancer patients who received anticoagulation treatment.
Interventions
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Retrospective cohort analysis using Swedish registries including the Cancer Registry, National Patient Registry, Prescribed Drug Registry, and Cause of Death Registry.
Eligibility Criteria
All patients diagnosed with cancer in Sweden from year 2013 to 2019.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (1)
Swedish registries
Multiple Locations, Many Locations, Sweden
Related Publications (1)
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.
PMID: 38735015DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2021
First Posted
December 9, 2021
Study Start
March 18, 2022
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
December 18, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.