NCT02210819

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,987 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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
DRUG	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.

Timeline

• Start date: 2014-06-27
• Primary completion: 2016-11-03
• Completion: 2017-01-20
• First posted: 2014-08-07
• Last updated: 2019-08-29

Locations

21 sites across 21 countries: Algeria, Egypt, Indonesia, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Philippines, Qatar, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, Turkey (Türkiye), Ukraine, United Arab Emirates