Satisfaction and Quality of Life in Patients With a Diagnosis of DVT (Deep Venous Thrombosis) Who Take Rivaroxaban

Bayer0 sites113 target enrollmentMay 2013

ConditionsVenous Thrombosis

InterventionsRivaroxaban (Xarelto, BAY59-7939)

DrugsRivaroxaban (Xarelto, BAY59-7939)

Overview

Phase: Not Applicable
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Conditions: Venous Thrombosis
Sponsor: Bayer
Enrollment: 113
Primary Endpoint: Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

June 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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.
•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

Arms & Interventions

Rivaroxaban

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

Intervention: Rivaroxaban (Xarelto, BAY59-7939)

Outcomes

Primary Outcomes

Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score

Time Frame: After 3 months

Secondary Outcomes

Physician's satisfaction at 1, 3 and 6 months assessed by a 5-point Likert scale response ("very satisfied", "satisfied", "neutral", "unsatisfied" or "very unsatisfied")(After 1, 3 and 6 months)
Patient's compliance with VKA treatment at baseline and with Xarelto treatment at 1, 3 and 6 months assessed by the investigator as good (≥80%), average (50-80%) or poor (<50%)(After 1, 3 and 6 months)
Continuation rate at 1, 3 and 6 months(After 1, 3 and 6 months)
Change of ACTS score after 1 and 6 months of treatment(After 1 and 6 months)
Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)(After 1, 3 and 6 months)