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

NCT01619007 | Completed

• 2 other identifiers: 15915XA1102
• Study Type: observational
• Target: 5,145
• Locations: 21 countries
• Sites: 21

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.

Conditions

Deep Vein Thrombosis; Venous Thrombosis

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

Group 1

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Group 2

Drug: Standard of care

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

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

Group 1

Standard of care DRUG

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In- and outpatients in sites participating in the study

You may qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (21)

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Belgium

Location

Unknown Facility

Many Locations, Canada

Location

Unknown Facility

Many Locations, Czechia

Location

Unknown Facility

Many Locations, Denmark

Location

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Greece

Location

Unknown Facility

Many Locations, Hungary

Location

Unknown Facility

Many Locations, Israel

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Moldova

Location

Unknown Facility

Many Locations, Netherlands

Location

Unknown Facility

Many Locations, Norway

Location

Unknown Facility

Many Locations, Portugal

Location

Unknown Facility

Many Locations, Slovenia

Location

Unknown Facility

Many Locations, Spain

Location

Unknown Facility

Many Locations, Sweden

Location

Unknown Facility

Many Locations, Switzerland

Location

Unknown Facility

Many Locations, Ukraine

Location

Unknown Facility

Many Locations, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31249987 DERIVED

• 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.

  PMID: 26765643 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Interventions

Rivaroxaban; Standard of Care

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 14, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

NO (1); CZ (1); IL (1); PT (1); SE (1); DK (1); NL (1); IT (1); BE (1); CA (1); DE (1); GR (1); HU (1); FR (1); MO (1); SL (1); ES (1); UA (1); AU (1); GB (1); CH (1)