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

Study Overview
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Brief Summary
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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.

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

Conditions
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Treatment of Venous Thromboembolism in Cancer Patients

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: other DOACs
* Drug: LMWH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer patients with VTE<br>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)<br>* Retrospective cohort analysis using Clinical Practice Research Datalink (CPRD) GOLD and Aurum Hospital Episode Statistics (HES)-linked datasets in UK.<br>Drug: other DOACs<br>* Retrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK.<br>Drug: LMWH<br>* Retrospective cohort analysis using CPRD GOLD and Aurum HES-linked datasets in UK.<br>|

What is the study measuring?
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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 |