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

Completed

• Conditions: Pulmonary Embolism (PE); Deep Vein Thrombosis (DVT)
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Recommended VTE pharmacological treatments according to international guidelines

• Registration Number: NCT02210819
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-20
• Study Start: 2014-06-27
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-07
• Primary Completion: 2016-11-03
• Study Completion: 2017-01-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1987

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY59-7939)	Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.
Standard of care	Recommended VTE pharmacological treatments according to international guidelines	Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care.

Primary Outcome Measures

Name	Time	Method
All cause mortality	Up to 2 years
Number of patients with symptomatic recurrent venous thromboembolic events	Up to 2 years
Number of major bleedings defined as overt bleeding	Up to 2 years	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

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction (patient reported outcomes)	Up to 2 years
Number of adverse cardiovascular events	Up to 2 years	Number of cardiovascular events will be used for descriptive statistics to summarize safety variables.
Number of patients with other symptomatic thromboembolic events	Up to 2 years