Clinical trial NCT01619007: Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy
Official title: Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Venous Thrombosis
Keywords: Treatment of Venous Thromboembolism
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2012-06-14
Enrollment: 5145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In- and outpatients in sites participating in the study

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: after approximately 2 years or 30 days after stop of therapy
measure: Number of patients with symptomatic recurrent venous thromboembolic events
timeFrame: after approximately 2 years or 30 days after stop of therapy
measure: All cause mortality
timeFrame: after approximately 2 years or 30 days after stop of therapy
Secondary outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection
timeFrame: after approximately 2 years or 30 days after stop of therapy
measure: Number of patients with other symptomatic thromboembolic events
timeFrame: after approximately 2 years or 30 days after stop of therapy
measure: Treatment satisfaction (patient reported outcomes)
timeFrame: after approximately 2 years or 30 days after stop of therapy
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Belgium
city: Many Locations
country: Canada
city: Many Locations
country: Czech Republic
city: Many Locations
country: Denmark
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Greece
city: Many Locations
country: Hungary
city: Many Locations
country: Israel
city: Many Locations
country: Italy
city: Many Locations
country: Moldova, Republic of
city: Many Locations
country: Netherlands
city: Many Locations
country: Norway
city: Many Locations
country: Portugal
city: Many Locations
country: Slovenia
city: Many Locations
country: Spain
city: Many Locations
country: Sweden
city: Many Locations
country: Switzerland
city: Many Locations
country: Ukraine
city: Many Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Ageno W, Mantovani LG, Haas S, Kreutz R, Monje D, Schneider J, Bugge JP, Gebel M, Turpie AGG. Patient Management Strategies and Long-Term Outcomes in Isolated Distal Deep-Vein Thrombosis versus Proximal Deep-Vein Thrombosis: Findings from XALIA. TH Open. 2019 Mar 26;3(1):e85-e93. doi: 10.1055/s-0039-1683968. eCollection 2019 Jan.
citation: Ageno W, Mantovani LG, Haas S, Kreutz R, Monje D, Schneider J, van Eickels M, Gebel M, Zell E, Turpie AG. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol. 2016 Jan;3(1):e12-21. doi: 10.1016/S2352-3026(15)00257-4. Epub 2015 Dec 8.