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

NCT03214172 | Completed

• 1 other identifier: 19622
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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)

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

15/20 mg

Cancer-associated thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

US database

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: July 11, 2017
• Study Start: July 15, 2017
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

US (1)