check_circleStudy Completed

Treatment of venous thromboembolism in cancer patients,

Bayer Identifier:

22020

ClinicalTrials.gov Identifier:

NCT05112666

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to gather information about rivaroxaban in patients in the United Kingdom who have cancer and thrombosis (OSCAR—UK)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
2601
Trial Dates
December 2021 - August 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, United Kingdom

Primary Outcome

  • The risk of recurrent VTE at 3-months
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • All-cause mortality at 3-months
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020

Secondary Outcome

  • Recurrent VTE at 6- and 12-months post-index VTE
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • Intracranial hemorrhage (ICH), critical organ bleeding and extracranial bleeding-related hospitalizations as separate outcomes
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • All-cause mortality at 6- and 12-months
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • Duration of anticoagulation treatment
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020
  • Discontinuation rates of rivaroxaban, DOAC and LMWH at 3-, 6-, 12-months and all available follow-up
    date_rangeTime Frame:
    Retrospective data analysis from 2013 to 2020

Trial design

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban – United Kingdom Cohort (OSCAR—UK)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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