Thrombosis, VenousNCT01691495
ARIXTRA® Adherence in SVT Patients.
An observational study of Thrombosis, Venous, run by GlaxoSmithKline.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Venous
- What is being tested?
- Fondaparinux
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of SVT
- Prescribed fondaparinux for the treatment of SVT
- Age 18 years or older
Who cannot join
- Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period.
About this study
Official title: ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (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.
Read more
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
- Being tested
- Fondaparinux
- Keywords
- Physician Adherence, superficial vein thrombosis, Fondaparinux
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FondaparinuxDrug
Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs
| Study group | Role | What they receive |
|---|---|---|
| Superficial Vein Thrombosis (SVT) | A representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries. Receives: Drug: Fondaparinux |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombosis, VenousStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691495
- Sponsor's protocol ID
- 115280
- Status last verified
- Mar 2015
- First submitted
- 20 Sep 2012
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (SVT) Patients.
- ClinicalTrials.gov ID
- NCT01691495
- Acronym / sponsor ID
- 115280
- Conditions
- Thrombosis, Venous
- Keywords
- Physician Adherence, superficial vein thrombosis, Fondaparinux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Superficial Vein Thrombosis (SVT) | – | Drug: FondaparinuxA representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of SVT
- Prescribed fondaparinux for the treatment of SVT
- Age 18 years or older
Key exclusion criteria (1 listed)
- Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FondaparinuxPhysician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs | Drug | Superficial Vein Thrombosis (SVT) |
Primary outcome
The primary outcome will be a measure of physician adherence.
Time frame: 2
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis, Venous, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be a measure of physician adherence. (time frame: 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.