ARIXTRA® Adherence in SVT Patients.

Completed

• Conditions: Thrombosis, Venous
• Interventions: Drug: Fondaparinux

• Registration Number: NCT01691495
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-24
• Study Start: 2012-10
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The primary outcome will be a measure of physician adherence.	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