University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT02502396
The primary objective of this study is to evaluate the practice patterns of rivaroxaban usage invenous-thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) in cancer patients.
The secondary objectives are to evaluate outcomes such as recurrent VTE, stroke and bleeding for cancer patients on rivaroxaban.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Houston, Texas, 77030, United States
This retrospective descriptive study will review charts of approximately 375 cancer patients prescribed rivaroxaban from January 1, 2012 to November 7, 2016 at UT MDACC for NVAF or patients that had prior VTE and diagnosis of cancer. The list of patients prescribed rivaroxaban during the study period will be obtained from Pharmacy Informatics. We will review the eligibility of all patients on the pharmacy list who were prescribed rivaroxaban during the study time-frame. The eligible patients who meet inclusion/exclusion criteria will be identified. All available data concerning demographic, clinical parameters and rivaroxaban usage will be collected for eligible patients from Pharmacy Informatics, CS, Laboratory Informatics, and Clinical Informatics Databases.
The variables of interest include demographic information, clinical parameters (tumor type, extent of disease, clinical exam findings, and presence of comorbidities, diagnostic assessments, and treatment interventions), reason for rivaroxaban discontinuation and outcomes. The confidentiality of all patient-specific data will be maintained. By using Pharmacy Informatics and CS, we can capture most of patients prescribed rivaroxaban at the UT MDACC.This is a descriptive study and the final sample size will depend on available records for chart review from 01/01/2012 to 11/07/2016.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Retrospective chart review study to evaluate Rivaroxaban's utilization in cancer patients for venous-thromboembolism (VTE) or non-valvular atrial fibrillation (NVAF). Study conducted from from January 1, 2012 to November 7, 2016 at MD Anderson Cancer Center in Houston, Texas.
Time frame: 1 year
Proportion (95% confidence interval (CI)) of cancer patients who were on rivaroxaban with indication of VTE obtained among cancer patients who were on rivaroxaban.
Analyses made among patients with VTE summarizing practice patterns of rivaroxaban by means, SDs, and ranges for continuous variables (e.g. platelet counts before a procedure) and the counts and percentages for categorical variables (e.g. stopping rivaroxaban before a procedure, stopping rivaroxaban when the platelets dropped < 50K, adjusting rivaroxaban dose when the platelets dropped < 50K, restarting rivaroxaban after it stopped).
Time frame: 1 year
Proportion (95% confidence interval (CI)) of cancer patients who were on rivaroxaban with indication of NVAF obtained among cancer patients who were on rivaroxaban.
Analyses made among patients with NVAF summarizing practice patterns of rivaroxaban by means, SDs, and ranges for continuous variables (e.g. platelet counts before a procedure) and the counts and percentages for categorical variables (e.g. stopping rivaroxaban before a procedure, stopping rivaroxaban when the platelets dropped < 50K, adjusting rivaroxaban dose when the platelets dropped < 50K, restarting rivaroxaban after it stopped).
Time frame: 1 year
Proportions of patients with recurrent stroke along with 95% CIs, estimated among patients with VTE . SAS 9.4 (SAS Institute INC, Cary, NC) used for data analysis.
Time frame: 1 year
Proportions of patients with recurrent bleeding, along with 95% CIs, estimated among patients with VTE. SAS 9.4 (SAS Institute INC, Cary, NC) used for data analysis.
Time frame: 1 year
Proportions of patients with recurrent NVAF along with 95% CIs, estimated among patients with NVAF. SAS 9.4 (SAS Institute INC, Cary, NC) used for data analysis.
Time frame: 1 year
Proportions of patients with recurrent bleeding, along with 95% CIs, estimated among patients with NVAF. SAS 9.4 (SAS Institute INC, Cary, NC) used for data analysis.
M.D. Anderson Cancer Center
Other
Retrospective Study: Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
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.
NCT04657120
Cancer, Cardiovascular Diseases
Antwerp, Belgium
View Trial DetailsNCT01602445
Cancer, Cardiovascular Diseases
Halifax, Nova Scotia, Canada
View Trial DetailsNCT02095925
Cancer, Cardiovascular Diseases
Colombes, Île-de-France Region, France
View Trial DetailsNCT00320255
Cancer, Cardiovascular Diseases
Tucson, Arizona, United States
View Trial Details