- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04979780
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort (OSCAR-US)
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
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Connecticut
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Multiple Locations, Connecticut, United States, 06093
- Many Locations
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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).
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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).
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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
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at 3 month after treatment
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Any clinically-relevant bleeding-related hospitalization
Time Frame: at 3 month after treatment
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Cunningham algorithm for identification of bleeding-associated hospitalizations
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at 3 month after treatment
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All-cause mortality
Time Frame: at 3 month after treatment
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at 3 month after treatment
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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
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at 6 and 12 months post-index VTE
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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
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including:
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at 6 and 12 months post-index VTE
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Any clinically-relevant bleeding-related hospitalization
Time Frame: at 6 and 12 months
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per the Cunningham algorithm for identification of bleeding-associated hospitalizations
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at 6 and 12 months
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Intracranial hemorrhage (ICH)
Time Frame: at 3, 6 and 12 months
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at 3, 6 and 12 months
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Critical organ bleeding
Time Frame: at 3, 6 and 12 months
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at 3, 6 and 12 months
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Extracranial bleeding-related hospitalizations
Time Frame: at 3, 6 and 12 months
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at 3, 6 and 12 months
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All-cause mortality at 6- and 12-months.
Time Frame: at 6 and 12 months
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at 6 and 12 months
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Incidence rates of recurrent VTE
Time Frame: at 3, 6 and 12 months
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Incidence rates of recurrent VTE in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.
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at 3, 6 and 12 months
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Incidence rates any clinically-relevant bleeding-related to recurrent VTE
Time Frame: at 3, 6 and 12 months
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Incidence rates of any clinically-relevant bleeding-related in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.
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at 3, 6 and 12 months
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All cause-mortality
Time Frame: at 3, 6 and 12 months
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Incidence rates of all cause-mortality in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.
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at 3, 6 and 12 months
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Duration of anticoagulation treatment
Time Frame: at 3, 6 and 12 months
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at 3, 6 and 12 months
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DOAC discontinuation rates at 3-, 6- and 12-months follow-up
Time Frame: at 3, 6 and 12 months
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at 3, 6 and 12 months
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LMWH discontinuation rates at 3-, 6- and 12-months follow-up
Time Frame: at 3, 6 and 12 months
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at 3, 6 and 12 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Thrombosis
- Thromboembolism
- Venous Thromboembolism
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Rivaroxaban
- Heparin
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
- Anticoagulants
Other Study ID Numbers
- 21982
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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