Clinical trial NCT02502396: Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Official title: Retrospective Study: Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Deep-vein Thrombosis of the Lower and Upper Extremities
Pulmonary Embolism
Non-valvular Atrial Fibrillation
Keywords: Cancer
Deep-vein thrombosis of the lower and upper extremities
Pulmonary embolism
Non-valvular atrial fibrillation
Chart review
VTE
NVAF
Rivaroxaban
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2015-07-20
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients with venous-thromboembolism (VTE) or non-valvular atrial fibrillation (NVAF) The University of Texas MD Anderson Cancer Center in Houston, Texas

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age range: patient must be ≥ 18 years.
2. Male and female patients will be eligible for enrollment.
3. Patients diagnosed with deep-vein thrombosis of the lower and upper extremities, pulmonary embolism or both or with non-valvular atrial fibrillation.
4. Patients must have active malignancy defined as a diagnosis of cancer (excluding basal cell squamous cell carcinoma of the skin) within six months before enrollment, have received any treatment for cancer within the previous six months or have documented recurrent or metastatic cancer .

Exclusion Criteria:

1. Patients who are on hemodialysis
2. Patients with valvular heart disease (using a coexisting prosthetic heart valve or have a hemodynamically significant valve disease)

Primary outcomes:
measure: Chart Review of Usage Pattern of Rivaroxaban in Participants with Cancer and Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center
timeFrame: 1 year
measure: Chart Review of Usage Pattern of Rivaroxaban in Participants with Cancer and Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center
timeFrame: 1 year
Secondary outcomes:
measure: Chart Review of Stroke Outcome Evaluation of Rivaroxaban in Cancer Participants with Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center
timeFrame: 1 year
measure: Chart Review of Bleeding Outcome Evaluation of Rivaroxaban in Cancer Participants with Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center
timeFrame: 1 year
measure: Chart Review of Stroke Outcome Evaluation of Rivaroxaban in Cancer Participants with Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center
timeFrame: 1 year
measure: Chart Review of Bleeding Outcome Evaluation of Rivaroxaban in Cancer Participants with Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Carmen Escalante, MD
role: PRINCIPAL_INVESTIGATOR
References: