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

Bayer

Status: Completed

Conditions: Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE)

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Recommended VTE pharmacological treatments according to international guidelines

Study type: Observational

Funder types: Industry

Identifiers

NCT02210819

17237

XA1402 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,987 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,987 participants in 2 patient groups

Rivaroxaban

Description:

Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Standard of care

Description:

Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care.

Treatment:

Drug: Recommended VTE pharmacological treatments according to international guidelines