Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy

Deep Vein Thrombosis (DVT) Clinical Trial

— XALIA LEA  

Official title:

XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210819
• Other study ID #: 17237
• Secondary ID: XA1402
• Status: Completed
• Start date: June 27, 2014
• Est. completion date: January 20, 2017

Study information

• Verified date: August 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE).

The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1987
• Est. completion date: January 20, 2017
• Est. primary completion date: November 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female or male patients, who are at >=18 years

• Diagnosis of acute DVT and/or PE, objectively confirmed

• Indication for anticoagulation therapy for at least 12 weeks

• Willing to participate in this study and available for follow-up

Exclusion Criteria:

• Exclusion criteria must be read in conjunction with the local product information.

Related Conditions & MeSH terms

• Deep Vein Thrombosis (DVT)
• Embolism
• Pulmonary Embolism
• Pulmonary Embolism (PE)
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine
• Recommended VTE pharmacological treatments according to international guidelines
Cohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

Algeria,  Egypt,  Indonesia,  Jordan,  Kazakhstan,  Kenya,  Korea, Republic of,  Kuwait,  Lebanon,  Malaysia,  Mexico,  Morocco,  Philippines,  Qatar,  Russian Federation,  Saudi Arabia,  Singapore,  Taiwan,  Turkey,  Ukraine,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of major bleedings defined as overt bleeding	Major bleedings defined as overt bleeding are associated with: A fall in hemoglobin of =2 g/dL; or a transfusion of =2 units of packed red blood cells or whole blood; or occurrence at a critical site	Up to 2 years
Primary	Number of patients with symptomatic recurrent venous thromboembolic events		Up to 2 years
Primary	All cause mortality		Up to 2 years
Secondary	Number of adverse cardiovascular events	Number of cardiovascular events will be used for descriptive statistics to summarize safety variables.	Up to 2 years
Secondary	Number of patients with other symptomatic thromboembolic events		Up to 2 years
Secondary	Treatment satisfaction (patient reported outcomes)		Up to 2 years

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