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

Completed

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

US database

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

15/20 mg

Primary outcomes

Recurrent Venous thromboembolism

Time frame: Retrospective analysis from November 2012 through September 2015

Derived using inpatient and outpatient medical claims
Bleeding (based on the Cunningham algorithm)

Time frame: Retrospective analysis from November 2012 through September 2015

Derived using inpatient and outpatient medical claims
Mortality (In-hospital mortality or need for hospice care without subsequent healthcare claims)

Time frame: Retrospective analysis from November 2012 through September 2015

Derived using inpatient and outpatient medical claims

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

Janssen Research & Development, LLC

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jul 11, 2017
Registry last updated: Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed