check_circleStudy Completed
Venous thrombosis
Bayer Identifier:
16409
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
113Trial Dates
May 2013 - June 2015Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, France |
Primary Outcome
- Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline scoredate_rangeTime Frame:After 3 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change of ACTS score after 1 and 6 months of treatmentdate_rangeTime Frame:After 1 and 6 monthsenhanced_encryptionNoSafety Issue:
- Continuation rate at 1, 3 and 6 monthsdate_rangeTime Frame:After 1, 3 and 6 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionNoSafety Issue:
- 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 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A