ARIXTRA® Adherence in SVT Patients.

Thrombosis, Venous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691495
• Other study ID #: 115280
• Status: Completed
• Phase: N/A
• First received: September 20, 2012
• Last updated: March 26, 2015
• Start date: October 2012
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Thrombosis
• Thrombosis, Venous
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No