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OpenTrials
Completed

NCT Number: NCT02210819

Treatment of Venous Thromboembolism (VTE) 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 venous thoromboembolism (VTE).

The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.

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Key information

Conditions

Deep Vein Thrombosis (DVT) Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Pulmonary Embolism (PE) Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Algeria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female or male patients, who are at >=18 years
  • Diagnosis of acute DVT and/or PE, objectively confirmed
  • Indication for anticoagulation therapy for at least 12 weeks
  • Willing to participate in this study and 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

Cohort participants are classified as "rivaroxaban" patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine

Recommended VTE pharmacological treatments according to international guidelines

Drug

Cohort participants are classified as "Standard of care" patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine.

Primary outcomes

  1. Number of major bleedings defined as overt bleeding

    Time frame: Up to 2 years

    Major bleedings defined as overt bleeding are 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

  2. Number of patients with symptomatic recurrent venous thromboembolic events

    Time frame: Up to 2 years

  3. All cause mortality

    Time frame: Up to 2 years

Secondary outcomes

  1. Number of adverse cardiovascular events

    Time frame: Up to 2 years

    Number of cardiovascular events will be used for descriptive statistics to summarize safety variables.

  2. Number of patients with other symptomatic thromboembolic events

    Time frame: Up to 2 years

  3. Treatment satisfaction (patient reported outcomes)

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia

Acronym: XALIA LEA

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 7, 2014
Registry last updated
Aug 29, 2019

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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