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)

Cancer Clinical Trial

— H2H-OSCAR-US  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461807
• Other study ID #: 22290
• Status: Completed
• Start date: July 14, 2022
• Est. completion date: October 5, 2022

Study information

• Verified date: October 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2437
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be =18 years of age at the time of anticoagulation initiation.

• Have active cancer defined as cancer being actively treated, diagnosed within 6-months prior of the index CAT or associated with metastatic disease (regardless of time from initial cancer diagnosis)

• Admitted to the hospital, emergency department or observation unit for acute Deep vein thrombosis (DVT) and/or Pulmonary embolism (PE)

• Started on a therapeutic VTE dose of rivaroxaban or apixaban within 7 days of the qualifying VTE event and treated with a therapeutic VTE dose of rivaroxaban or apixaban as their first anticoagulant on day 7 post-acute CAT event diagnosis (index date) to increase the probability of accurately classifying patients' intended outpatient anticoagulant for CAT treatment, and that, patients are compared at the same point from diagnosis.

• Have been active in the data set for at least 12-months prior to the index event (based on the "First Month Active" field) and had at least one provider visit in the 12-months prior to the acute VTE event (baseline period).

Exclusion Criteria:

• Oesophageal, gastric, unresected colorectal, bladder, central nervous system cancers (except brain) and leukaemia

• Evidence of atrial fibrillation, recent hip/knee replacement (within 35 days of index VTE), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis, or mitral valve repair/replacement.

• Pregnancy.

• Initiation of non-therapeutic VTE doses of rivaroxaban or apixaban.

• Evidence of anticoagulation use written prescription or patient self-report during the 12-months prior to the qualifying CAT event per.

Related Conditions & MeSH terms

• Cancer
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Retrospective cohort analysis using United States Optum De-Identified Electronic Health Records data
• Apixaban
Retrospective cohort analysis using United States Optum De-Identified Electronic Health Records data

Locations

Country	Name	City	State
Germany	Bayer	Wuppertal

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months		Retrospective data analysis from January,2013 to December,2020
Primary	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 months		Retrospective data analysis from January,2013 to December,2020
Primary	Recurrent VTE (fatal and non-fatal) at 3 months		Retrospective data analysis from January,2013 to December,2020
Primary	Any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months		Retrospective data analysis from January,2013 to December,2020
Primary	Critical organ bleeding (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 3 months		Retrospective data analysis from January,2013 to December,2020
Secondary	Composite of recurrent VTE (fatal and non-fatal) or any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 months		Retrospective data analysis from January,2013 to December,2020
Secondary	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 months		Retrospective data analysis from January,2013 to December,2020
Secondary	Recurrent VTE (fatal and non-fatal) at 6 months		Retrospective data analysis from January,2013 to December,2020
Secondary	Any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 months		Retrospective data analysis from January,2013 to December,2020
Secondary	Critical organ bleeding (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial, or intramuscular with compartment syndrome) at 6 months		Retrospective data analysis from January,2013 to December,2020

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