NCT01855100

Brief Summary

The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

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

May 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

May 14, 2013

Last Update Submit

January 17, 2017

Conditions

Venous Thrombosis

Keywords

Treatment of acute deep vein thrombosisPrevention of recurrenceOral anticoagulationReal-life setting

Outcome Measures

Primary Outcomes (6)

  • Number of patients with major bleedings

    up to 1 year or 30 days after end of rivaroxaban

  • Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE)

    up to 1 year or 30 days after end of rivaroxaban

  • All-cause mortality

    up to 1 year or 30 days after end of rivaroxaban

  • Adverse events

    up to 1 year or 30 days after end of rivaroxaban

  • Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)

    up to 1 year or 30 days after end of rivaroxaban

  • Quantities of resource use consumption

    up to 1 year or 30 days after end of rivaroxaban

Study Arms (1)

Rivaroxaban

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.

Rivaroxaban

Eligibility Criteria

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

Ambulatory or hospitalized patients coming from the vascular diseases clinic of the participating hospitals

You may qualify if:

  • Adult patients with a diagnosis of deep vein thrombosis (DVT) within the past 9 months, enabling at least 3 months of therapy

You may not qualify if:

  • Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Belgium

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

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

May 14, 2013

First Posted

May 16, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

BE(1)