NCT02502396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 28, 2015

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

6.5 years

First QC Date

July 14, 2015

Last Update Submit

March 22, 2022

Conditions

CancerDeep-vein Thrombosis of the Lower and Upper ExtremitiesPulmonary EmbolismNon-valvular Atrial Fibrillation

Keywords

CancerDeep-vein thrombosis of the lower and upper extremitiesPulmonary embolismNon-valvular atrial fibrillationChart reviewVTENVAFRivaroxaban

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    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

    1 year

  • Chart Review of Bleeding Outcome Evaluation of Rivaroxaban in Cancer Participants with Invenous-Thromboembolism (VTE) at MD Anderson Cancer Center

    1 year

  • Chart Review of Stroke Outcome Evaluation of Rivaroxaban in Cancer Participants with Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center

    1 year

  • Chart Review of Bleeding Outcome Evaluation of Rivaroxaban in Cancer Participants with Non-Valvular Atrial Fibrillation (NVAF) at MD Anderson Cancer Center

    1 year

Study Arms (1)

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).

Other: Retrospective Chart Review

Interventions

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.

Chart Review - Patterns of Rivaroxaban Usage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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 .

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsPulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Carmen Escalante, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 20, 2015

Study Start

September 28, 2015

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations

US(1)