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

This study is currently recruiting participants.
Verified March 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01619007
First received: May 29, 2012
Last updated: March 18, 2014
Last verified: March 2014

May 29, 2012
March 18, 2014
June 2012
March 2015   (final data collection date for primary outcome 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 [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]
  • Number of patients with symptomatic recurrent venous thromboembolic events [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01619007 on ClinicalTrials.gov Archive Site
  • Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]
  • Number of patients with other symptomatic thromboembolic events [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]
  • Treatment satisfaction (patient reported outcomes) [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy
Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

In- and outpatients in sites participating in the study

  • Deep Vein Thrombosis
  • Venous Thrombosis
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban
  • Drug: 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
  • Group 1
    Intervention: Drug: Rivaroxaban (Xarelto, BAY59-7939)
  • Group 2
    Intervention: Drug: Standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4800
June 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Moldova, Republic of,   Netherlands,   Norway,   Poland,   Portugal,   Slovakia,   Slovenia,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom
 
NCT01619007
15915, XA1102
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP