A Study to Gather Information About Rivaroxaban in Patients in the United Kingdom Who Have Cancer and Thrombosis (OSCAR-UK)

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United Kingdom Cohort (OSCAR-UK)

Patients with cancer are more likely than those without cancer to develop blood clots (deep vein thrombosis and pulmonary embolism), which are treated using blood thinners (anticoagulants). When clots occur, cancer patients carry a higher risk of recurring clots and more likely to bleed on blood thinning treatments. Therefore, it is critical to use blood thinners that optimize the safety and benefits.

There are two main types of blood thinners that are recommended. The tablets which are direct-acting oral anticoagulants and the injections (low molecular-weight heparin). Clinical trials show the tablets may reduce clot risk but may potentially lead to more frequent bleeding, particularly in those with certain risk factors such as stomach ulcers, previous bleeding problems, certain cancer type.

We aim to examine the effectiveness and safety of the tablets versus the injections for treatment of clots in cancer patients, to better understand these treatments' benefits and risks.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 2601

Contacts and Locations

Study Locations

• United Kingdom
  • Multiple Locations, United Kingdom
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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 experiencing a hospitalization or emergency department admission or a primary care visit with an incident VTE, being administered rivaroxaban or other DOACs or a LMWH on or after January 1, 2013.

Description

Inclusion Criteria:

• Be ≥18 years of age at the time of anticoagulation initiation
• Have active cancer and acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
• Treated with rivaroxaban (or any DOAC) or LMWH as their first recorded anticoagulant prescription 7 to 30 days post-acute CAT event diagnosis
• Have been active in the data set for at least 12-months prior to the index event and had at least one provider visit in the 12-months prior to the acute VTE event

Exclusion Criteria:

• Evidence of atrial fibrillation, recent hip/knee replacement (with 90 days of CAT), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement
• History of inferior vena cava filter before cohort entry
• vitamin K antagonist (VKA) use between cohort entry and index day (initiation of DOAC or LMWH)
• Evidence of any type of therapeutic anticoagulation use during all available look-back period per written prescription or patient self-report
• Initiation of rivaroxaban or other DOACs or LMWH during the study period at non-therapeutic doses (e.g., enoxaparin at a dose other than 1 mg/kg twice daily or 1.5 mg/kg once daily; dalteparin at a dose other than 200 IU/kg of total body weight)
• Pregnancy
• Recording indicative of palliative care before cohort entry
• Any clinically-relevant bleeding-related d hospitalization or VTE recurrence between the initial CAT and the start of observation

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 VTE; Adults diagnosed with active (primary or metastatic) cancer experiencing a hospitalization or emergency department admission or a primary care visit with an incident venous thromboembolism (VTE), being administered rivaroxaban or other direct-acting oral anticoagulants (DOACs) or a low molecular weight heparin (LMWH) will be included.	Drug: Rivaroxaban (Xarelto, BAY59-7939); Retrospective cohort analysis using Clinical Practice Research Datalink (CPRD) GOLD and Aurum Hospital Episode Statistics (HES)-linked datasets in UK.; Drug: other DOACs; Retrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK.; Drug: LMWH; Retrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The risk of recurrent VTE at 3-months		Retrospective data analysis from 2013 to 2020
Composite of any major bleeding or clinically-relevant non-major bleeding-related hospitalization at 3-months	Per the International Society on Thrombosis and Haemostasis (ISTH) criteria [9, 10] for identification of bleeding-associated hospitalizations.	Retrospective data analysis from 2013 to 2020
All-cause mortality at 3-months		Retrospective data analysis from 2013 to 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent VTE at 6- and 12-months post-index VTE		Retrospective data analysis from 2013 to 2020
Composite of any major or clinically-relevant non-major bleeding-related hospitalization at 6- and 12-months post-index VTE	Including: Intracranial hemorrhage (ICH); Critical organ bleeding (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial bleeding or intramuscular with compartment syndrome); Extracranial bleeding-related hospitalizations (including trauma-related)	Retrospective data analysis from 2013 to 2020
Composite of any major bleeding or clinically-relevant non-major bleeding-related hospitalization at 6 and 12-months	Per the ISTH criteria [9, 10] for identification of bleeding-associated hospitalizations.	Retrospective data analysis from 2013 to 2020
Intracranial hemorrhage (ICH), critical organ bleeding and extracranial bleeding-related hospitalizations as separate outcomes		Retrospective data analysis from 2013 to 2020
All-cause mortality at 6- and 12-months		Retrospective data analysis from 2013 to 2020
Incidence rates of recurrent VTE in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type		Retrospective data analysis from 2013 to 2020
Any clinically-relevant bleeding-related hospitalization in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type		Retrospective data analysis from 2013 to 2020
All cause-mortality in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type		Retrospective data analysis from 2013 to 2020
Duration of anticoagulation treatment		Retrospective data analysis from 2013 to 2020
Discontinuation rates of rivaroxaban, DOAC and LMWH at 3-, 6-, 12-months and all available follow-up		Retrospective data analysis from 2013 to 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): December 2, 2021
• Primary Completion (Actual): August 26, 2022
• Study Completion (Actual): August 26, 2022

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 22020

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