check_circleStudy Completed

Venous thrombosis

Bayer Identifier:

16409

ClinicalTrials.gov Identifier:

NCT01805544

EudraCT Number:

Not Available

EU CT Number:

Not Available
Satisfaction/Quality of Life with Rivaroxaban in DVT (deep venous thrombosis) indication

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
113
Trial Dates
May 2013 - June 2015
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, France

Primary Outcome

  • Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
    date_rangeTime Frame:
    After 3 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change of ACTS score after 1 and 6 months of treatment
    date_rangeTime Frame:
    After 1 and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Continuation rate at 1, 3 and 6 months
    date_rangeTime Frame:
    After 1, 3 and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)
    date_rangeTime Frame:
    After 1, 3 and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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”)
    date_rangeTime Frame:
    After 1, 3 and 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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%)
    date_rangeTime Frame:
    After 1, 3 and 6 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Satisfaction and Quality of Life in patients with a diagnosis of DVT (deep venous thrombosis) who take Rivaroxaban
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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