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) (H2H-OSCAR-US)

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)

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Venous Thromboembolism; Treatment of Venous Thromboembolism in Cancer Patients
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Apixaban

• Study Type: Observational
• Enrollment (Actual): 2437

Contacts and Locations

Study Locations

• Germany
  • Wuppertal, Germany, 42096
    • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with active (primary or metastatic) cancer excluding oesophageal, gastric, unresected colorectal, bladder, central nervous system cancers (except brain) and leukaemia (a cohort of CAT patients at a low risk for bleeding, which is defined as per ISTH guidelines), experiencing a hospital, emergency department, or observation unit admission with a primary diagnosis code for VTE, who received therapeutic VTE doses of rivaroxaban or apixaban as their first outpatient anticoagulant (index event) within 7-days of the acute VTE event and were active in the data set for at least 12-months prior to the CAT event and with at least one provider visit in the 12-months prior to the acute CAT event (establishing a 12-month look back/baseline period).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cancer patients with venous thromboembolism (VTE); Adults diagnosed with active (primary or metastatic) cancer excluding oesophageal, gastric, unresected colorectal, bladder, central nervous system cancers (except brain) and leukaemia (a cohort of CAT (Cancer-associated thrombosis) patients at a low risk for bleeding, which is defined as per the ISTH (International Society on Thrombosis and Haemostasis) guidelines), admitted to the hospital, emergency department or observation unit for acute DVT (Deep vein thrombosis) and/or PE (Pulmonary embolism) on or after January 1, 2013 (to correspond with the US availability of rivaroxaban for VTE treatment), being treated with a therapeutic VTE dose of rivaroxaban or apixaban on day 7 post-acute VTE diagnosis (index date).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
Recurrent VTE (fatal and non-fatal) at 3 months	Retrospective data analysis from January,2013 to December,2020
Any bleed resulting in hospitalization (per the Cunningham algorithm) at 3 months	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 months	Retrospective data analysis from January,2013 to December,2020

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Recurrent VTE (fatal and non-fatal) at 6 months	Retrospective data analysis from January,2013 to December,2020
Any bleed resulting in hospitalization (per the Cunningham algorithm) at 6 months	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 months	Retrospective data analysis from January,2013 to December,2020

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Apixaban
• Other Study ID Numbers: 22290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No