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ARIXTRA® Adherence in SVT Patients.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01691495
Enrollment
1
Registered
2012-09-24
Start date
2012-10-31
Completion date
2014-08-31
Last updated
2015-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis, Venous

Keywords

Physician Adherence, superficial vein thrombosis, Fondaparinux

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.

Interventions

DRUGFondaparinux

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

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome will be a measure of physician adherence.2adherence 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026