Clinical trial NCT01805544: Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication
Official title: Satisfaction and Quality of Life in Patients With a Diagnosis of DVT (Deep Venous Thrombosis) Who Take Rivaroxaban
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis
Keywords: SF36 questionnaire
Anti Clot Treatment Scale
Satisfaction
Quality of Life
Rivaroxaban
Prevention & control
Pulmonary embolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2013-03-06
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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 6.1.
  * 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

Primary outcomes:
measure: Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
timeFrame: After 3 months
Secondary outcomes:
measure: Change of ACTS score after 1 and 6 months of treatment
timeFrame: After 1 and 6 months
measure: Continuation rate at 1, 3 and 6 months
timeFrame: After 1, 3 and 6 months
measure: Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)
timeFrame: After 1, 3 and 6 months
measure: 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")
timeFrame: After 1, 3 and 6 months
measure: 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%)
timeFrame: After 1, 3 and 6 months
Other outcomes:
Locations:
city: Many locations
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: