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

Conditions

Deep Vein Thrombosis, Venous Thrombosis

Keywords

Treatment of Venous Thromboembolism, Thromboembolism, Venous Thromboembolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Thrombosis

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.

de Jong LA, Gout-Zwart JJ, van den Bosch M, Koops M, Postma MJ.

2019-01-1510 citations

10.1080/13696998.2018.1563404

Patient Management Strategies and Long-Term Outcomes in Isolated Distal Deep-Vein Thrombosis versus Proximal Deep-Vein Thrombosis: Findings from XALIA

Walter Ageno, LG Mantovani, Sylvia Haas, Reinhold Kreutz, Danja Monje et al. (9 authors)

TH Open2019-01-0129 citations

10.1055/s-0039-1683968

Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study.

Ageno W, Mantovani LG, Haas S, Kreutz R, Monje D, Schneider J, van Eickels M, Gebel M, Zell E, Turpie AG.

2015-12-08157 citations

10.1016/s2352-3026(15)00257-4

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban

DRUGStandard 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

*

Design outcomes

Primary

Measure	Time frame
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
Number of patients with symptomatic recurrent venous thromboembolic events	after approximately 2 years or 30 days after stop of therapy
All cause mortality	after approximately 2 years or 30 days after stop of therapy

Secondary

Measure	Time frame
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
Number of patients with other symptomatic thromboembolic events	after approximately 2 years or 30 days after stop of therapy
Treatment satisfaction (patient reported outcomes)	after approximately 2 years or 30 days after stop of therapy

Countries

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

Outcome results

None listed