Overview

This trial is active, not recruiting.

Condition venous thromboembolism
Treatments rivaroxaban (xarelto, bay59-7939), recommended vte pharmacological treatments according to international guidelines
Phase phase 4
Sponsor Bayer
Start date June 2014
End date October 2016
Trial size 1990 participants
Trial identifier NCT02210819, 17237, XA1402

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.
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
Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care.
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.

Primary Outcomes

Measure
Number of major bleedings defined as overt bleeding
time frame: Up to 2 years
Number of patients with symptomatic recurrent venous thromboembolic events
time frame: Up to 2 years
All cause mortality
time frame: Up to 2 years

Secondary Outcomes

Measure
Number of adverse cardiovascular events
time frame: Up to 2 years
Number of patients with other symptomatic thromboembolic events
time frame: Up to 2 years
Treatment satisfaction (patient reported outcomes)
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.