CancerNCT02502396
Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
An observational study of Cancer and Deep-vein Thrombosis of the Lower and Upper Extremities, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Deep-vein Thrombosis of the Lower and Upper Extremities, Pulmonary Embolism
- What is being tested?
- Retrospective Chart Review
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2015to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age range: patient must be ≥ 18 years.
- Male and female patients will be eligible for enrollment.
- Patients diagnosed with deep-vein thrombosis of the lower and upper extremities, pulmonary embolism or both or with non-valvular atrial fibrillation.
- 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 .
Who cannot join
- Patients who are on hemodialysis
- Patients with valvular heart disease (using a coexisting prosthetic heart valve or have a hemodynamically significant valve disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Deep-vein Thrombosis of the Lower and Upper Extremities, Pulmonary Embolism, Non-valvular Atrial Fibrillation
- Being tested
- Retrospective Chart Review
- Keywords
- Cancer, Deep-vein thrombosis of the lower and upper extremities, Pulmonary embolism, Non-valvular atrial fibrillation, Chart review, VTE, NVAF, Rivaroxaban
- Medical subject headings
- Neoplasms, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Chart ReviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chart Review - Patterns of Rivaroxaban Usage | Retrospective chart review study to evaluate Rivaroxaban's utilization in cancer patients for venous-thromboembolism (VTE) or non-valvular atrial fibrillation (NVAF). Receives: Other: Retrospective Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chart Review of Usage Pattern of Rivaroxaban in Participants with Cancer and Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center
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).
Measured: 1 year
Chart Review of Usage Pattern of Rivaroxaban in Participants with Cancer and Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center
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).
Measured: 1 year
Secondary outcomes (4)
Chart Review of Stroke Outcome Evaluation of Rivaroxaban in Cancer Participants with Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center
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.
Measured: 1 year
Chart Review of Bleeding Outcome Evaluation of Rivaroxaban in Cancer Participants with Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center
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.
Measured: 1 year
Chart Review of Stroke Outcome Evaluation of Rivaroxaban in Cancer Participants with Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center
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.
Measured: 1 year
Chart Review of Bleeding Outcome Evaluation of Rivaroxaban in Cancer Participants with Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study start28 Sep 2015
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Carmen Escalante, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502396
- Sponsor's protocol ID
- PA14-1027
- Status last verified
- Mar 2022
- First submitted
- 14 Jul 2015
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study: Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
- ClinicalTrials.gov ID
- NCT02502396
- Acronym / sponsor ID
- PA14-1027
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 28 Sep 2015 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chart Review - Patterns of Rivaroxaban Usage | – | Other: Retrospective Chart ReviewRetrospective chart review study to evaluate Rivaroxaban's utilization in cancer patients for venous-thromboembolism (VTE) or non-valvular atrial fibrillation (NVAF). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Age range: patient must be ≥ 18 years.
- Male and female patients will be eligible for enrollment.
- Patients diagnosed with deep-vein thrombosis of the lower and upper extremities, pulmonary embolism or both or with non-valvular atrial fibrillation.
- 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 .
Key exclusion criteria (2 listed)
- Patients who are on hemodialysis
- Patients with valvular heart disease (using a coexisting prosthetic heart valve or have a hemodynamically significant valve disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective Chart ReviewRetrospective 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. | Other | Chart Review - Patterns of Rivaroxaban Usage |
Primary outcome
Chart Review of Usage Pattern of Rivaroxaban in Participants with Cancer and Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center
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).
Chart Review of Usage Pattern of Rivaroxaban in Participants with Cancer and Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center
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).
4 secondary outcomes
Chart Review of Stroke Outcome Evaluation of Rivaroxaban in Cancer Participants with Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center
Time frame: 1 year
Chart Review of Bleeding Outcome Evaluation of Rivaroxaban in Cancer Participants with Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center
Time frame: 1 year
Chart Review of Stroke Outcome Evaluation of Rivaroxaban in Cancer Participants with Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center
Time frame: 1 year
Chart Review of Bleeding Outcome Evaluation of Rivaroxaban in Cancer Participants with Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Escalante, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Deep-vein Thrombosis of the Lower and Upper Extremities, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chart Review of Usage Pattern of Rivaroxaban in Participants with Cancer and Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.