Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban

To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • US database

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases is used. The Truven Health MarketScan® Research Databases capture person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services. Individuals enrolled in the MarketScan databases are largely representative of the United States population in terms of age, sex, and type of health insurance coverage. The data come from a selection of large employers, health plans, and government and public organizations and contain claims from approximately 100 employers, health plans, and government and public organizations representing about 50 million covered lives across all age groups. The data elements to be used in the proposed study will include health plan enrollment records, participant demographics, inpatient and outpatient medical claims and outpatient prescription drug dispensing records.

Description

Inclusion Criteria:

• Adult patients (≥18 years-of-age) with active cancer
• Patient with at least one index venous thromboembolism (VTE )
• ≥6-months of continuous eligibility prior to the index VTE event (baseline period).
• Newly initiated on rivaroxaban

Exclusion Criteria:

• Patients with any medical claim for Deep vein thrombosis (DVT) or Pulmonary embolism (PE) during the 6 months pre-index date
• Patients with prescription claim for anticoagulation therapy during the 6-month pre-index VTE period

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer-associated thrombosis; Adult patients with active cancer with at least one index venous thromboembolism (VTE) and no anticoagulation use during the 6-months (baseline period) prior to the index VTE event	Drug: Rivaroxaban (Xarelto, BAY59-7939); 15/20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent Venous thromboembolism	Derived using inpatient and outpatient medical claims	Retrospective analysis from November 2012 through September 2015
Bleeding (based on the Cunningham algorithm)	Derived using inpatient and outpatient medical claims	Retrospective analysis from November 2012 through September 2015
Mortality (In-hospital mortality or need for hospice care without subsequent healthcare claims)	Derived using inpatient and outpatient medical claims	Retrospective analysis from November 2012 through September 2015

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2017
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): September 15, 2017

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 9, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: 19622

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No