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OpenTrials
Completed

NCT Number: NCT01619007

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

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.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

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

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

Primary outcomes

  1. 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

  2. Number of patients with symptomatic recurrent venous thromboembolic events

    Time frame: after approximately 2 years or 30 days after stop of therapy

  3. All cause mortality

    Time frame: after approximately 2 years or 30 days after stop of therapy

Secondary outcomes

  1. 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

  2. Number of patients with other symptomatic thromboembolic events

    Time frame: after approximately 2 years or 30 days after stop of therapy

  3. Treatment satisfaction (patient reported outcomes)

    Time frame: after approximately 2 years or 30 days after stop of therapy

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)

Acronym: XALIA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 14, 2012
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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