NCT01805544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

March 5, 2013

Last Update Submit

January 20, 2017

Conditions

Venous Thrombosis

Keywords

SF36 questionnaireAnti Clot Treatment ScaleSatisfactionQuality of LifeRivaroxabanPrevention & controlPulmonary embolism

Outcome Measures

Primary Outcomes (1)

  • Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score

    After 3 months

Secondary Outcomes (5)

  • Change of ACTS score after 1 and 6 months of treatment

    After 1 and 6 months

  • Continuation rate at 1, 3 and 6 months

    After 1, 3 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

  • 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

Study Arms (1)

Rivaroxaban

20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment

Rivaroxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, France

Location

MeSH Terms

Conditions

Venous ThrombosisPersonal SatisfactionPulmonary Embolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesBehaviorLung DiseasesRespiratory Tract DiseasesEmbolism

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 6, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

FR(1)