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CompletedNCT01691495Updated Mar 27, 2015

ARIXTRA® Adherence in SVT Patients.

An observational study in Thrombosis, Venous, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-27.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
1
Ages
18 Years and older
Sex
All
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Study summary

Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic disease. It has recently been approved in the European Union (EU) for the treatment of patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed to evaluate physicians' adherence to fondaparinux prescribing information regarding proper diagnosis and dosing for the treatment of SVT.

The primary objective is to evaluate physicians' adherence to fondaparinux prescribing information for the treatment of patients with SVT without concomitant DVT.

The study is designed as a non-interventional, retrospective chart review of patients prescribed fondaparinux to treat their SVT. The study will be conducted in several EU countries.

ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.

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Conditions studied

  • Thrombosis, Venous

Keywords

  • Physician Adherence
  • superficial vein thrombosis
  • Fondaparinux
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In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 1 is below the median of 213 across 586 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Up to 12 clinical sites representative of geographical regions of several EU countries, targeting physician adherence to prescribing in approximately 840 patients with SVT.

Inclusion criteria

  • Diagnosis of SVT
  • Prescribed fondaparinux for the treatment of SVT
  • Age 18 years or older

Exclusion criteria

Exclusion Criteria:

  • Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period.
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Study design

Time perspective
Retrospective
Enrollment
1 participant (actual)

Groups and cohorts

  • Superficial Vein Thrombosis (SVT)

    A representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries.

    Drug: Fondaparinux

Interventions

  • DrugFondaparinux

    Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs

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What researchers measure

Primary outcomes

  1. The primary outcome will be a measure of physician adherence.

    adherence described as the percentage of patients for whom both an ultrasound (or other objective measure) was performed in order to rule out concomitant DVT prior to patients commencing fondaparinux

    Time frame: 2

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01691495
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 24, 2012
Start date
Oct 2012
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Mar 27, 2015

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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