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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

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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