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

January 20, 2017 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Many locations, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients more than 18 years old, with a diagnosis of acute DVT treated with VKA with issues, who switch from VKA to Xarelto

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rivaroxaban
20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment
Drug: Rivaroxaban (Xarelto, BAY59-7939)
20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
Time Frame: After 3 months
After 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of ACTS score after 1 and 6 months of treatment
Time Frame: After 1 and 6 months
After 1 and 6 months
Continuation rate at 1, 3 and 6 months
Time Frame: After 1, 3 and 6 months
After 1, 3 and 6 months
Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)
Time Frame: After 1, 3 and 6 months
After 1, 3 and 6 months
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")
Time Frame: After 1, 3 and 6 months
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%)
Time Frame: After 1, 3 and 6 months
After 1, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (ESTIMATE)

March 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16409
  • XA1214FR (OTHER: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Venous Thrombosis

Clinical Trials on Rivaroxaban (Xarelto, BAY59-7939)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe