Clinical trial NCT02210819: Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy
Official title: XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Keywords: Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2014-08-07
Enrollment: 1987
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In- and outpatients in sites participating in the study.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of major bleedings defined as overt bleeding
timeFrame: Up to 2 years
measure: Number of patients with symptomatic recurrent venous thromboembolic events
timeFrame: Up to 2 years
measure: All cause mortality
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of adverse cardiovascular events
timeFrame: Up to 2 years
measure: Number of patients with other symptomatic thromboembolic events
timeFrame: Up to 2 years
measure: Treatment satisfaction (patient reported outcomes)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Multiple Locations
country: Algeria
city: Multiple Locations
country: Egypt
city: Multiple Locations
country: Indonesia
city: Multiple Locations
country: Jordan
city: Multiple Locations
country: Kazakhstan
city: Multiple Locations
country: Kenya
city: Multiple Locations
country: Korea, Republic of
city: Multiple Locations
country: Kuwait
city: Multiple Locations
country: Lebanon
city: Multiple Locations
country: Malaysia
city: Multiple Locations
country: Mexico
city: Multiple Locations
country: Morocco
city: Multiple Locations
country: Philippines
city: Multiple Locations
country: Qatar
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Saudi Arabia
city: Multiple Locations
country: Singapore
city: Multiple Locations
country: Taiwan
city: Multiple Locations
country: Turkey
city: Multiple Locations
country: Ukraine
city: Multiple Locations
country: United Arab Emirates
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: