NCT05461807

An Observational Study Called H2H-OSCAR-US to Learn More About How Well Rivaroxaban Works and How Safe it is Compared to Apixaban Under Real World Conditions in People in the US With Cancer Who Have Problems Due to Formation of Blood Clots in the Veins (Venous Thromboembolism)

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,437 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Treatment of Venous Thromboembolism in Cancer Patients
• Venous Thromboembolism
• Cancer

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Retrospective cohort analysis using United States Optum De-Identified Electronic Health Records data
DRUG	Apixaban	Retrospective cohort analysis using United States Optum De-Identified Electronic Health Records data

Timeline

• Start date: 2022-07-14
• Primary completion: 2022-10-05
• Completion: 2022-10-05
• First posted: 2022-07-18
• Last updated: 2022-10-26

Locations

1 site across 1 country: Germany