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

NCT ID: NCT05112666

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2601 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-02
• Study Completion Date: 2022-08-26

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

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

other DOACs

Intervention Type: DRUG

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

LMWH

Intervention Type: DRUG

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

Interventions

Rivaroxaban (Xarelto, BAY59-7939)

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

Intervention Type: DRUG

other DOACs

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

Intervention Type: DRUG

LMWH

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Many locations

Multiple Locations, , United Kingdom

Countries

United Kingdom

Related Links

https://clinicaltrials.bayer.com/

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Other Identifiers

22020

Identifier Type: -

Identifier Source: org_study_id