Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy

Bayer1,987 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,987

Conditions

Deep Vein Thrombosis (DVT)Pulmonary Embolism (PE)

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (21)

Unnamed facility

Multiple Locations, Algeria

Unnamed facility

Multiple Locations, Egypt

Unnamed facility

Multiple Locations, Indonesia

Outcomes

Primary Outcomes

Number of major bleedings defined as overt bleeding

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

Time frame: Up to 2 years

Number of patients with symptomatic recurrent venous thromboembolic events

Time frame: Up to 2 years

All cause mortality

Time frame: Up to 2 years

Secondary Outcomes

Number of adverse cardiovascular events

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

Time frame: Up to 2 years

Number of patients with other symptomatic thromboembolic events

Time frame: Up to 2 years

Treatment satisfaction (patient reported outcomes)

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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