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

NCT05112666 | Completed

• 1 other identifier: 22020
• Study Type: observational
• Target: 2,601
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Treatment of Venous Thromboembolism in Cancer Patients

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

  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

  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

Study Arms (1)

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); Drug: other DOACs; Drug: LMWH

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

Retrospective cohort analysis using Clinical Practice Research Datalink (CPRD) GOLD and Aurum Hospital Episode Statistics (HES)-linked datasets in UK.

Cancer patients with VTE

other DOACs DRUG

Retrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK.

Cancer patients with VTE

LMWH DRUG

Retrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK.

Cancer patients with VTE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Many locations

Multiple Locations, United Kingdom

Location

Related 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.

MeSH Terms

Interventions

Rivaroxaban; Heparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: December 2, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)