Trial Condition(s):
Deep Vein Thrombosis
Treatment of an acute deep vein thrombosis (DVT) with either rivaroxaban or current standard of care therapy (XALIA)
Bayer Identifier:
15915
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 deep vein thrombosis (DVT).
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.
Inclusion Criteria
- Female and male patients - Patients >= 18 years - Patiebts with diagnosis of acute DVT and who have an indication for anticoagulation therapy for at least 12 weeks, who are willing to participate in this study and are 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 | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Switzerland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Belgium | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Netherlands | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Sweden | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Denmark | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Norway | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Czech Republic | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Portugal | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Austria | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Hungary | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Greece | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Ukraine | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovenia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Moldova | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Canada | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Major bleedings defined as overt bleeding 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: after approximately 2 years or 30 days after stop of therapy
- Number of patients with symptomatic recurrent venous thromboembolic eventsTimeframe: after approximately 2 years or 30 days after stop of therapy
- All cause mortalityTimeframe: after approximately 2 years or 30 days after stop of therapy
Secondary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse cardiac events collectionTimeframe: after approximately 2 years or 30 days after stop of therapy
- Number of patients with other symptomatic thromboembolic eventsTimeframe: after approximately 2 years or 30 days after stop of therapy
- Treatment satisfaction (patient reported outcomes)Timeframe: after approximately 2 years or 30 days after stop of therapy
Additional Information
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