Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort (OSCAR-US)

November 5, 2023 updated by: Bayer

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).

Study Overview

Study Type

Observational

Enrollment (Actual)

3708

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • Multiple Locations, Connecticut, United States, 06093
        • Many Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The Optum EHR database includes longitudinal patient-level medical record data for ~91+ million patients seen at ~700+ hospitals and ~7,000+ clinics across the US. The study population of interest will be patients with cancer, admitted to the hospital, emergency department or observation unit for acute DVT and/or PE on or after January 1, 2013 (to correspond with the US availability of rivaroxaban for VTE treatment), being treated with rivaroxaban (or any DOAC in secondary analysis) or LMWH on day 7 post-acute VTE diagnosis (index date), and 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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer patients with acute venous thromboembolism (VTE)
Cancer-associated thrombosis (CAT) patients treated with Rivaroxaban or any DOAC (Direct Oral Anticoagulants) or LMWH (Low molecular weight heparin).
Retrospective cohort analysis using US Optum De-Identified EHR data.
Retrospective cohort analysis using US Optum De-Identified EHR data. LMWH (dalteparin, enoxaparin, tinzaparin)
Retrospective cohort analysis using US Optum De-Identified EHR data. DOAC (apixaban, dabigatran, edoxaban, rivaroxaban).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent VTE at 6- and 12-months post-index VTE
Time Frame: at 6 and 12 months post-index VTE
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
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
at 6 and 12 months post-index VTE
Any clinically-relevant bleeding-related hospitalization
Time Frame: at 6 and 12 months
per the Cunningham algorithm for identification of bleeding-associated hospitalizations
at 6 and 12 months
Intracranial hemorrhage (ICH)
Time Frame: at 3, 6 and 12 months
at 3, 6 and 12 months
Critical organ bleeding
Time Frame: at 3, 6 and 12 months
at 3, 6 and 12 months
Extracranial bleeding-related hospitalizations
Time Frame: at 3, 6 and 12 months
at 3, 6 and 12 months
All-cause mortality at 6- and 12-months.
Time Frame: at 6 and 12 months
at 6 and 12 months
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.
at 3, 6 and 12 months
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.
at 3, 6 and 12 months
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.
at 3, 6 and 12 months
Duration of anticoagulation treatment
Time Frame: at 3, 6 and 12 months
at 3, 6 and 12 months
DOAC discontinuation rates at 3-, 6- and 12-months follow-up
Time Frame: at 3, 6 and 12 months
at 3, 6 and 12 months
LMWH discontinuation rates at 3-, 6- and 12-months follow-up
Time Frame: at 3, 6 and 12 months
at 3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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