Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication (SATORI)
This study is not yet open for participant recruitment.
Verified April 2013 by Bayer
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01805544
First received: March 5, 2013
Last updated: April 30, 2013
Last verified: April 2013
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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.
| Condition | Intervention |
|---|---|
|
Venous Thrombosis |
Drug: Rivaroxaban (Xarelto, BAY59-7939) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Satisfaction and Quality of Life in Patients With a Diagnosis of DVT (Deep Venous Thrombosis) Who Take Rivaroxaban |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change of ACTS score after 1 and 6 months of treatment [ Time Frame: After 1 and 6 months ] [ Designated as safety issue: No ]
- Continuation rate at 1, 3 and 6 months [ Time Frame: After 1, 3 and 6 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as 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") [ Time Frame: After 1, 3 and 6 months ] [ Designated as 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%) [ Time Frame: After 1, 3 and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 550 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Rivaroxaban |
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805544
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| France | |
| Not yet recruiting | |
| Many locations, France | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01805544 History of Changes |
| Other Study ID Numbers: | 16409, XA1214FR |
| Study First Received: | March 5, 2013 |
| Last Updated: | April 30, 2013 |
| Health Authority: | France: none |
Keywords provided by Bayer:
|
SF36 questionnaire Anti Clot Treatment Scale Satisfaction Quality of Life |
Rivaroxaban Prevention & control Pulmonary embolism |
Additional relevant MeSH terms:
|
Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Thromboembolism |
ClinicalTrials.gov processed this record on May 19, 2013