Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy

Deep Vein Thrombosis Clinical Trial

— XALIA  

Official title:

Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619007
• Other study ID #: 15915
• Secondary ID: XA1102
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: January 20, 2017
• Start date: June 2012
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5145
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban
• Standard of care
Patients who will be treated for an acute deep vein thrombosis (DVT) with current standard of care comprising e.g. of initial treatment with low-molecular weight heparin or fondaparinux, followed by oral Vitamin-K antagonist for at least 3 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Moldova, Republic of,  Netherlands,  Norway,  Portugal,  Slovenia,  Spain,  Sweden,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 site		after approximately 2 years or 30 days after stop of therapy
Primary	Number of patients with symptomatic recurrent venous thromboembolic events		after approximately 2 years or 30 days after stop of therapy
Primary	All cause mortality		after approximately 2 years or 30 days after stop of therapy
Secondary	Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection		after approximately 2 years or 30 days after stop of therapy
Secondary	Number of patients with other symptomatic thromboembolic events		after approximately 2 years or 30 days after stop of therapy
Secondary	Treatment satisfaction (patient reported outcomes)		after approximately 2 years or 30 days after stop of therapy

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