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

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT03214172
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-09
• Study First Posted: 2017-07-11
• Study Start: 2017-07-15
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer-associated thrombosis	Rivaroxaban (Xarelto, BAY59-7939)	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

Primary Outcome Measures

Name	Time	Method
Recurrent Venous thromboembolism	Retrospective analysis from November 2012 through September 2015	Derived using inpatient and outpatient medical claims
Bleeding (based on the Cunningham algorithm)	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)	Retrospective analysis from November 2012 through September 2015	Derived using inpatient and outpatient medical claims

Trial Locations

Locations (1)

US database; 🇺🇸 New York, New York, United States