ARIXTRA® Adherence in SVT Patients.
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Superficial Thrombophlebitis |
Drug: Fondaparinux |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 1 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Superficial Vein Thrombosis (SVT)
A representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries.
|
Drug: Fondaparinux
Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Up to 12 clinical sites representative of geographical regions of several EU countries, targeting physician adherence to prescribing in approximately 840 patients with SVT.
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01691495 History of Changes |
| Other Study ID Numbers: | 115280 |
| Study First Received: | September 20, 2012 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
Fondaparinux Physician Adherence superficial vein thrombosis |
Additional relevant MeSH terms:
|
Thrombophlebitis Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Phlebitis Peripheral Vascular Diseases Vasculitis Fondaparinux |
PENTA Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013