Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05461807
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2022-07-14
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
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
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
H2H-OSCAR-US
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None