Bayer
Wuppertal, 42096, Germany
NCT Number: NCT05461807
This is an observational study in which patient data from the past on venous thromboembolism (VTE) in people with cancer is studied. In observational studies, only observations are made without specified advice or interventions.
People with VTE have 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 lungs, which can lead to their damage. VTE can also be "recurrent". This means that the blood clots have returned after treatment. People who have cancer are more likely to develop VTE, recurrent clots, and bleeding on blood thinning treatments.
To prevent the formation of new or recurrent clots in people with cancer, a newer type of blood thinner is available, called direct-acting oral anticoagulant (DOAC). Rivaroxaban and apixaban are the most used DOACs in the US. They work by blocking a certain step in the blood clotting process, the activation of a protein called Factor X.
Previous studies show that DOACs may reduce clot risk compared to other available treatments but may potentially lead to more frequent bleeding. Studies looking at these points in direct comparison of rivaroxaban and apixaban a currently missing.
Therefore, this study will collect real-world data from the US to learn how well rivaroxaban works and how safe it is compared to apixaban in people with cancer and VTE who are at low risk for bleeding.
To do this, researchers will look at the proportion of patients that will develop:
* recurrent blood clots in the veins after treatment * bleeding in a critical organ * bleeding that requires a hospital stay within 3 and 6 months after participants had a VTE that was treated with rivaroxaban or apixaban.
De-identified data collected will cover 12 months before and at maximum 6 months after this VTE. They will come from US electronic health records and will cover the years 2012 to 2020.
No visits or tests are required as part of this study.
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Notify Me18 year and older
All sexes
Observational
Wuppertal, 42096, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Retrospective cohort analysis using United States Optum De-Identified Electronic Health Records data
Retrospective cohort analysis using United States Optum De-Identified Electronic Health Records data
Time frame: Retrospective data analysis from January,2013 to December,2020
Time frame: Retrospective data analysis from January,2013 to December,2020
Time frame: Retrospective data analysis from January,2013 to December,2020
Time frame: Retrospective data analysis from January,2013 to December,2020
Time frame: Retrospective data analysis from January,2013 to December,2020
Time frame: Retrospective data analysis from January,2013 to December,2020
Time frame: Retrospective data analysis from January,2013 to December,2020
Time frame: Retrospective data analysis from January,2013 to December,2020
Time frame: Retrospective data analysis from January,2013 to December,2020
Time frame: Retrospective data analysis from January,2013 to December,2020
Bayer
Industry
Effectiveness and Safety of Rivaroxaban Compared With Apixaban in Cancer-Associated Venous Thromboembolism: A Head-to-Head (H2H) Analysis of the United States Cohort of the Observational Study in Cancer Associated Thrombosis for Rivaroxaban (H2H-OSCAR-US)
Acronym: H2H-OSCAR-US
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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