check_circleStudy Completed

Treatment of venous thromboembolism in cancer patients, Prophylaxis of recurrent venous thromboembolism in cancer patients

Bayer Identifier:

21982

ClinicalTrials.gov Identifier:

NCT04979780

EudraCT Number:

Not Available

EU CT Number:

Not Available
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban – United States Cohort

Trial purpose

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).

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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).
  • - 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

Trial summary

Enrollment Goal
3708
Trial Dates
July 2021 - March 2022
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, 06093, United States

Primary Outcome

  • Risk of recurrent VTE
    date_rangeTime Frame:
    at 3 month after treatment
  • Any clinically-relevant bleeding-related hospitalization
    Cunningham algorithm for identification of bleeding-associated hospitalizations
    date_rangeTime Frame:
    at 3 month after treatment
  • All-cause mortality
    date_rangeTime Frame:
    at 3 month after treatment

Secondary Outcome

  • Recurrent VTE at 6- and 12-months post-index VTE
    date_rangeTime Frame:
    at 6 and 12 months post-index VTE
  • Composite of any major or clinically-relevant nonmajor 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
    date_rangeTime Frame:
    at 6 and 12 months post-index VTE
  • Any clinically-relevant bleeding-related hospitalization
    per the Cunningham algorithm for identification of bleeding-associated hospitalizations
    date_rangeTime Frame:
    at 6 and 12 months
  • Intracranial hemorrhage (ICH)
    date_rangeTime Frame:
    at 3, 6 and 12 months
  • Critical organ bleeding
    date_rangeTime Frame:
    at 3, 6 and 12 months
  • Extracranial bleeding-related hospitalizations
    date_rangeTime Frame:
    at 3, 6 and 12 months
  • All-cause mortality at 6- and 12-months.
    date_rangeTime Frame:
    at 6 and 12 months
  • Incidence rates of recurrent VTE
    Incidence rates of recurrent VTE in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.
    date_rangeTime Frame:
    at 3, 6 and 12 months
  • Incidence rates any clinically-relevant bleeding-related to recurrent VTE
    Incidence rates of any clinically-relevant bleeding-related in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.
    date_rangeTime Frame:
    at 3, 6 and 12 months
  • All cause-mortality
    Incidence rates of all cause-mortality in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.
    date_rangeTime Frame:
    at 3, 6 and 12 months
  • Duration of anticoagulation treatment
    date_rangeTime Frame:
    at 3, 6 and 12 months
  • DOAC discontinuation rates at 3-, 6- and 12-months follow-up
    date_rangeTime Frame:
    at 3, 6 and 12 months
  • LMWH discontinuation rates at 3-, 6- and 12-months follow-up
    date_rangeTime Frame:
    at 3, 6 and 12 months

Trial design

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban – United States Cohort
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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