check_circleStudy Completed
Treatment of Venous Thromboembolism in Cancer Patients, Venous thromboembolism, Cancer
Bayer Identifier:
22290
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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)
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
2437Trial Dates
July 2022 - October 2022Phase
Phase 4Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bayer | Wuppertal, 42096, Germany |
Primary Outcome
- Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
- Composite of recurrent VTE (fatal and non-fatal) or any critical organ bleed (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 3 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
- Recurrent VTE (fatal and non-fatal) at 3 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
- Any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
- Critical organ bleeding (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 3 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
Secondary Outcome
- Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
- Composite of recurrent VTE (fatal and non-fatal) or any critical organ bleed (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 6 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
- Recurrent VTE (fatal and non-fatal) at 6 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
- Any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
- Critical organ bleeding (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 6 monthsdate_rangeTime Frame:Retrospective data analysis from January,2013 to December,2020
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A