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NCT03214172 Clinical Trial

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

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03214172
Other study ID # 19622
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2017
Est. completion date September 15, 2017

Study information
Verified date September 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date September 15, 2017
Est. primary completion date September 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
15/20 mg

Locations
Country Name City State
United States US database New York New York

Sponsors (2)
Lead Sponsor Collaborator
Bayer Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrent Venous thromboembolism Derived using inpatient and outpatient medical claims Retrospective analysis from November 2012 through September 2015
Primary Bleeding (based on the Cunningham algorithm) Derived using inpatient and outpatient medical claims Retrospective analysis from November 2012 through September 2015
Primary 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
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