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OpenTrials
Completed

NCT Number: NCT05112666

A Study to Gather Information About Rivaroxaban in Patients in the United Kingdom Who Have Cancer and Thrombosis (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

other DOACs

Drug

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

LMWH

Drug

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

Primary outcomes

  1. The risk of recurrent VTE at 3-months

    Time frame: Retrospective data analysis from 2013 to 2020

  2. Composite of any major bleeding or clinically-relevant non-major bleeding-related hospitalization at 3-months

    Time frame: Retrospective data analysis from 2013 to 2020

    Per the International Society on Thrombosis and Haemostasis (ISTH) criteria [9, 10] for identification of bleeding-associated hospitalizations.

  3. All-cause mortality at 3-months

    Time frame: Retrospective data analysis from 2013 to 2020

Secondary outcomes

  1. Recurrent VTE at 6- and 12-months post-index VTE

    Time frame: Retrospective data analysis from 2013 to 2020

  2. Composite of any major or clinically-relevant non-major bleeding-related hospitalization at 6- and 12-months post-index VTE

    Time frame: Retrospective data analysis from 2013 to 2020

    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)
  3. Composite of any major bleeding or clinically-relevant non-major bleeding-related hospitalization at 6 and 12-months

    Time frame: Retrospective data analysis from 2013 to 2020

    Per the ISTH criteria [9, 10] for identification of bleeding-associated hospitalizations.

  4. Intracranial hemorrhage (ICH), critical organ bleeding and extracranial bleeding-related hospitalizations as separate outcomes

    Time frame: Retrospective data analysis from 2013 to 2020

  5. All-cause mortality at 6- and 12-months

    Time frame: Retrospective data analysis from 2013 to 2020

  6. 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

    Time frame: Retrospective data analysis from 2013 to 2020

  7. 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

    Time frame: Retrospective data analysis from 2013 to 2020

  8. All cause-mortality in rivaroxaban, DOAC and LMWH patients experiencing cancer-associated thrombosis (CAT) regardless of the bleeding risk associated with cancer type

    Time frame: Retrospective data analysis from 2013 to 2020

  9. Duration of anticoagulation treatment

    Time frame: Retrospective data analysis from 2013 to 2020

  10. Discontinuation rates of rivaroxaban, DOAC and LMWH at 3-, 6-, 12-months and all available follow-up

    Time frame: Retrospective data analysis from 2013 to 2020

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2021
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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