Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05150938
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2021-11-18
Brief Title:
A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis OSCAR-SE
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden OSCAR-SE
Status:
COMPLETED
Status Verified Date:
2023-12
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:
None
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
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
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