Many Locations
Multiple Locations, Connecticut, 06093, United States
NCT Number: NCT04979780
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Multiple Locations, Connecticut, 06093, United States
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: at 3 month after treatment
Time frame: at 3 month after treatment
Cunningham algorithm for identification of bleeding-associated hospitalizations
Time frame: at 3 month after treatment
Time frame: at 6 and 12 months post-index VTE
Time frame: at 6 and 12 months post-index VTE
including:
Time frame: at 6 and 12 months
per the Cunningham algorithm for identification of bleeding-associated hospitalizations
Time frame: at 3, 6 and 12 months
Time frame: at 3, 6 and 12 months
Time frame: at 3, 6 and 12 months
Time frame: at 6 and 12 months
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.
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.
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.
Time frame: at 3, 6 and 12 months
Time frame: at 3, 6 and 12 months
Time frame: at 3, 6 and 12 months
Bayer
Industry
Acronym: OSCAR-US
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.
Published trials that share one or more normalized conditions with this study.
NCT05150938
Treatment of Venous Thromboembolism in Cancer Patients
Multiple Locations, Many Locations, Sweden
View Trial DetailsNCT05112666
Treatment of Venous Thromboembolism in Cancer Patients
Multiple Locations, United Kingdom
View Trial DetailsNCT05461807
Cancer, Cardiovascular Diseases
Wuppertal, Germany
View Trial Details