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.
|Study Design:||Time Perspective: Retrospective|
|Official Title:||ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (SVT) Patients.|
- The primary outcome will be a measure of physician adherence. [ Time Frame: 2 ] [ Designated as safety issue: No ]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
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Superficial Vein Thrombosis (SVT)
A representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries.
Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691495
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|