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Trial record 1 of 1 for:    NCT05112666
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A Study to Gather Information About Rivaroxaban in Patients in the United Kingdom Who Have Cancer and Thrombosis (OSCAR-UK)

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ClinicalTrials.gov Identifier: NCT05112666
Recruitment Status : Completed
First Posted : November 9, 2021
Last Update Posted : September 21, 2022
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Study Description
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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.


Condition or disease Intervention/treatment
Treatment of Venous Thromboembolism in Cancer Patients Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: other DOACs Drug: LMWH

Study Design
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Study Type : Observational
Actual Enrollment : 2601 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United Kingdom Cohort (OSCAR-UK)
Actual Study Start Date : December 2, 2021
Actual Primary Completion Date : August 26, 2022
Actual Study Completion Date : August 26, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05112666


Locations
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United Kingdom
Many locations
Multiple Locations, United Kingdom
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT05112666    
Other Study ID Numbers: 22020
First Posted: November 9, 2021    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
 Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants