Trial Condition(s):
Deep vein thrombosis (DVT), pulmonary embolism (PE)
Treatment of venous thromboembolism (VTE) with either rivaroxaban or current standard of care therapy (XALIA LEA)
Bayer Identifier:
17237
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Mexico | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Turkey | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, South Korea | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Taiwan, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Malaysia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Philippines | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Singapore | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Egypt | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Saudi Arabia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kuwait | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Jordan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Lebanon | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Qatar | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Arab Emirates | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kenya | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Indonesia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Kazakhstan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Ukraine | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Algeria | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Morocco | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Number of major bleedings defined as overt bleedingMajor 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 siteTimeframe: Up to 2 years
- Number of patients with symptomatic recurrent venous thromboembolic eventsTimeframe: Up to 2 years
- All cause mortalityTimeframe: Up to 2 years
Secondary Outcome
- Number of adverse cardiovascular eventsNumber of cardiovascular events will be used for descriptive statistics to summarize safety variables.Timeframe: Up to 2 years
- Number of patients with other symptomatic thromboembolic eventsTimeframe: Up to 2 years
- Treatment satisfaction (patient reported outcomes)Timeframe: Up to 2 years
Additional Information
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