Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication (SATORI)

Bayer

Status: Completed

Conditions: Venous Thrombosis

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT01805544

XA1214FR (Other Identifier)

16409

Details and patient eligibility

About

National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female or male subject ≥ 18 years of age,
• With a diagnosis of acute DVT treated with VKA with issues for at least the 4 previous weeks (issues are assessed on medical judgment)
• Who intends to start rivaroxaban for treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT
• With anticoagulation therapy planned for at least 3 months

Exclusion criteria

• Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are:

  • Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1.
  • Lesion or condition at significant risk of major bleeding
  • Concomitant treatment with any other anticoagulant agent
  • Clinically significant active bleeding
  • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
  • Pregnancy and breast feeding

Trial design

113 participants in 1 patient group

Rivaroxaban

Description:

20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)