ARIXTRA® Adherence in SVT Patients.

NCT01691495 | Completed

• 1 other identifier: 115280
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thrombosis, Venous

Keywords

Physician Adherence; superficial vein thrombosis; Fondaparinux

Outcome Measures

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

  2

Study Arms (1)

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

Fondaparinux DRUG

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

Superficial Vein Thrombosis (SVT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 24, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 27, 2015

Record last verified: 2015-03