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OpenTrials
Completed

NCT Number: NCT01691495

ARIXTRA® Adherence in SVT Patients.

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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Key information

Conditions

Thrombosis, Venous Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

fondaparinux

Drug

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

Primary outcomes

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

    Time frame: 2

    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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (SVT) Patients.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2012
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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