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Completed

NCT Number: NCT04979780

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort

Patients with active cancer are ~5-fold more likely to develop a venous thromboembolism (VTE) than those without. When VTE occurs, cancer patients carry an up to a 3-fold higher rate of thrombosis recurrence and ~twice the risk of bleeding during anticoagulation. Therefore, it is critical to utilize anticoagulants that optimize efficacy while minimizing bleeding risk when treating cancer-associated thrombosis (CAT).

Guidelines list direct-acting oral anticoagulants (DOACs) as an alternative to low molecular-weight heparin (LMWH) for treatment of CAT. The strength-of-recommendation for DOACs is based on data from multiple randomized controlled trials (RCTs) comparing them to LMWHs to treat CAT, with results suggesting DOACs may reduce thrombosis risk but with potentially more frequent bleeding (particularly in those with certain gastrointestinal and genitourinary cancers).

Observational studies evaluating DOACs for CAT treatment have been published, but these studies have been either single-arm, evaluated cancer subtypes not recommended for DOAC treatment, were of limited sample size and/or employed heterogeneous definitions of active cancer. We seek to evaluate the effectiveness and safety of rivaroxaban versus LMWH for CAT treatment in active cancer patients using a large de-identified electronic health record database.

Retrospective cohort analysis using US Optum® De-Identified EHR data. We will use Optum EHR (electronic health records) data from November January 1, 2012 through latest available data (currently September 2020).

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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, Connecticut, 06093, United States

Who can participate

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 admitted to the hospital, emergency department or observation unit for acute DVT and/or PE.
  • Treated with rivaroxaban (or any DOAC in secondary analysis) or LMWH as their first anticoagulant on day 7 post-acute CAT event diagnosis (index date) o increase the probability of accurately classifying patients' intended outpatient anticoagulant for CAT treatment and that patients are compared at the same point from diagnosis.
  • Have been active in the data set for at least 12-months prior to the index event (based on the "First Month Active" field) and had at least one provider visit in the 12-months prior to the acute VTE event (baseline period).

Exclusion criteria

  • Evidence of atrial fibrillation, recent hip/knee replacement (within 35 days of index VTE), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis, or mitral valve repair/replacement.
  • Pregnancy.
  • Initiation of rivaroxaban at a dose other than 15 mg twice daily or non-therapeutic doses of other DOAC or LMWH (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)
  • Evidence of use of anticoagulation use during the 12-months prior per written prescription or patient self-report

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Retrospective cohort analysis using US Optum De-Identified EHR data.

Low Molecular Weight Heparin (LMWH)

Drug

Retrospective cohort analysis using US Optum De-Identified EHR data. LMWH (dalteparin, enoxaparin, tinzaparin)

Direct Oral Anticoagulants (DOAC)

Drug

Retrospective cohort analysis using US Optum De-Identified EHR data. DOAC (apixaban, dabigatran, edoxaban, rivaroxaban).

Primary outcomes

  1. Risk of recurrent VTE

    Time frame: at 3 month after treatment

  2. Any clinically-relevant bleeding-related hospitalization

    Time frame: at 3 month after treatment

    Cunningham algorithm for identification of bleeding-associated hospitalizations

  3. All-cause mortality

    Time frame: at 3 month after treatment

Secondary outcomes

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

    Time frame: at 6 and 12 months post-index VTE

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

    Time frame: 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
  3. Any clinically-relevant bleeding-related hospitalization

    Time frame: at 6 and 12 months

    per the Cunningham algorithm for identification of bleeding-associated hospitalizations

  4. Intracranial hemorrhage (ICH)

    Time frame: at 3, 6 and 12 months

  5. Critical organ bleeding

    Time frame: at 3, 6 and 12 months

  6. Extracranial bleeding-related hospitalizations

    Time frame: at 3, 6 and 12 months

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

    Time frame: at 6 and 12 months

  8. Incidence rates of recurrent VTE

    Time frame: at 3, 6 and 12 months

    Incidence rates of recurrent VTE in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.

  9. Incidence rates any clinically-relevant bleeding-related to recurrent VTE

    Time frame: at 3, 6 and 12 months

    Incidence rates of any clinically-relevant bleeding-related in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.

  10. All cause-mortality

    Time frame: at 3, 6 and 12 months

    Incidence rates of all cause-mortality in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.

  11. Duration of anticoagulation treatment

    Time frame: at 3, 6 and 12 months

  12. DOAC discontinuation rates at 3-, 6- and 12-months follow-up

    Time frame: at 3, 6 and 12 months

  13. LMWH discontinuation rates at 3-, 6- and 12-months follow-up

    Time frame: at 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: OSCAR-US

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2021
Registry last updated
Oct 31, 2024

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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