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

Completed

• Conditions: Venous Thrombosis
• Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT01805544
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-06
• Study Start: 2013-05
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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