Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center



Status:Active, not recruiting
Conditions:Atrial Fibrillation, Cancer, Cancer, Cardiology, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/26/2018
Start Date:September 28, 2015
End Date:September 2020

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Retrospective Study: Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center

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.

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.

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)
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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