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Trial record 5 of 654 for:    "Venous Thrombosis"
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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 May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01619007
First received: May 29, 2012
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Deep Vein Thrombosis
Venous Thrombosis
 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Standard of care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)

Resource links provided by NLM:

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4800
Study Start Date: June 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban
Group 2 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

In- and outpatients in sites participating in the study

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:

  • Patients with acute symptomatic pulmonary embolism
  • Other exclusion criteria must be read in conjunction with the local product information.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619007

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 23 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01619007     History of Changes
Other Study ID Numbers: 15915, XA1102
Study First Received: May 29, 2012
Last Updated: May 8, 2013
Health Authority: Austria: Federal Office for Safety in Health Care Austria: Austrian Medicines and Medical Device Agency
Austria: Ethikkommission
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway: Regional Ethics Commitee
Switzerland: Swissmedic
Switzerland: Ethikkommission
Sweden: Regional Ethical Review Board
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Hungary: Scientific and Medical Research Council Ethics Committee
Belgium: Ethics Committee
Czech Republic: State Institute for Drug Control
Israel: Ethics Commission
Netherlands: Independent Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee
Portugal: National Pharmacy and Medicines Institute
Ukraine: Ethics Committee
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Bayer:
Treatment of Venous Thromboembolism
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

Additional relevant MeSH terms:
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013