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

• ClinicalTrials.gov Identifier: NCT05150938
• Recruitment Status: Completed
• First Posted: December 9, 2021
• Last Update Posted: March 16, 2023
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Treatment of Venous Thromboembolism in Cancer Patients	Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Low molecular weight heparin (LMWH); Drug: vitamin K antagonist (VKA); Drug: other NOACs

Study Design

• Study Type: Observational
• Actual Enrollment: 5737 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)
• Actual Study Start Date: March 18, 2022
• Actual Primary Completion Date: February 28, 2023
• Actual Study Completion Date: February 28, 2023

Groups and Cohorts

Group/Cohort

Intervention/treatment

Cancer patients with VTE; Cancer patients who received anticoagulation treatment.

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

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with cancer in Sweden from year 2013 to 2019.

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

Contacts and Locations

Locations

Sweden

Swedish registries

Multiple Locations, Many Locations, Sweden

Sponsors and Collaborators

Bayer

Janssen Research & Development, LLC

More Information

Additional Information:

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field. 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT05150938
• Other Study ID Numbers: 21616
• First Posted: December 9, 2021
• Last Update Posted: March 16, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Thrombosis; Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Vitamin K; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Rivaroxaban; Vitamins; Micronutrients; Physiological Effects of Drugs; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Antifibrinolytic Agents; Hemostatics; Coagulants