Acute Coronary SyndromeNCT01406301
Fondaparinux EU-RMP (Adherence)
An observational study of Acute Coronary Syndrome, run by GlaxoSmithKline.
Trial summary
Fondaparinux, a synthetic and specific factor Xa inhibitor, was granted an ACS indication by Health Canada in March 2007 and by the EMEA in September 2007. Among ACS patients, fondaparinux is indicated for the treatment of UA/NSTEMI in patients for whom urgent PCI (within 2 hours) is not indicated, and for the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- fondaparinux
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jul 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitals with the capacity to perform cardiac catheterizations and PCIs will be identified. Sites will be further qualified based upon the expectation of an adequate number of ACS patients and the known or potential use of fondaparinux by the site. A minimum of 5 sites per country will be targeted in order to achieve a within-country representative sample. The study is planned for 7 countries in Europe and North America. Based on sample size estimates, approximately 32 physicians per country (6 to 7 per site) and approximately 256 patients per country (assuming an average of 8 patients per physician) will be targeted for inclusion, yielding a study total of approximately 1800 patients.
Who may be able to join
- Discharge diagnosis of ACS (UA/NSTEMI or STEMI)
- PCI during the hospitalization
- Anticoagulant treatment with fondaparinux
Who cannot join
- Enrollment at the time of the index hospitalization in a clinical study that could influence ACS treatment practices, specifically the in-hospital use of anticoagulation
About this study
Official title: Evaluate (Post Approval) the Adherence to the Prescribing Information for ARIXTRA® (Fondaparinux) in ACS Patients- Commitment of the Fondaparinux EU-RMP
Fondaparinux, a synthetic and specific factor Xa inhibitor, was granted an ACS indication by Health Canada in March 2007 and by the EMEA in September 2007. Among ACS patients, fondaparinux is indicated for the treatment of UA/NSTEMI in patients for whom urgent PCI (within 2 hours) is not indicated, and for the treatment of STEMI in patients who are managed with thrombolytics or who are initially to receive no other form of reperfusion therapy. The approved prescribing information for fondaparinux in ACS provides recommendations for use in patients undergoing PCI. The purpose of this study is to evaluate physician adherence to this prescribing information in ACS patients treated with fondaparinux and who undergo PCI. The primary endpoint is the proportion of patients with ACS treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI). Measurement of the effectiveness or safety of fondaparinux use in ACS patients is not within the scope of this study.
ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.
- Conditions
- Acute Coronary Syndrome
- Being tested
- fondaparinux
- Keywords
- prescribing information
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fondaparinuxDrug
fondaparinux
| Study group | Role | What they receive |
|---|---|---|
| Patients with a discharge diagnosis of ACS (UA/NSTEMI or STEMI | Patients with a discharge diagnosis of ACS (UA/NSTEMI or STEMI) Receives: Drug: fondaparinux |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with ACS treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI)
Measured: ACS hospitalizations that occur at least one month after the availability of reimbursement for fondaparinux for the UA/NSTEMI and STEMI indications at that particular site are eligible
Secondary outcomes (3)
The proportion of patients with UA/NSTEMI treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI)
Measured: ACS hospitalizations that occur at least one month after the availability of reimbursement for fondaparinux for the UA/NSTEMI and STEMI indications at that particular site are eligible
The proportion of patients with STEMI treated with fondaparinux, where fondaparinux is not administered prior to or during primary PCI
Measured: ACS hospitalizations that occur at least one month after the availability of reimbursement for fondaparinux for the UA/NSTEMI and STEMI indications at that particular site are eligible
The proportion of patients with STEMI treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI)
Measured: ACS hospitalizations that occur at least one month after the availability of reimbursement for fondaparinux for the UA/NSTEMI and STEMI indications at that particular site are eligible
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startMar 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Observational model
- Cohort
- 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
- NCT01406301
- Sponsor's protocol ID
- 113652
- Other IDs
- WEUSRTP2284, EPI40495
- Status last verified
- Apr 2015
- First submitted
- 28 Jul 2011
- Last updated
- 27 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate (Post Approval) the Adherence to the Prescribing Information for ARIXTRA® (Fondaparinux) in ACS Patients- Commitment of the Fondaparinux EU-RMP
- ClinicalTrials.gov ID
- NCT01406301
- Acronym / sponsor ID
- 113652
- Conditions
- Acute Coronary Syndrome
- Keywords
- prescribing information
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Aug 2011 (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, a synthetic and specific factor Xa inhibitor, was granted an ACS indication by Health Canada in March 2007 and by the EMEA in September 2007. Among ACS patients, fondaparinux is indicated for the treatment of UA/NSTEMI in patients for whom urgent PCI (within 2 hours) is not indicated, and for the treatment of STEMI in patients who are managed with thrombolytics or who are initially to receive no other form of reperfusion therapy. The approved prescribing information for fondaparinux in ACS provides recommendations for use in patients undergoing PCI. The purpose of this study is to evaluate physician adherence to this prescribing information in ACS patients treated with fondaparinux and who undergo PCI. The primary endpoint is the proportion of patients with ACS treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI). Measurement of the effectiveness or safety of fondaparinux use in ACS patients is not within the scope of this study.
ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a discharge diagnosis of ACS (UA/NSTEMI or STEMI | – | Drug: fondaparinuxPatients with a discharge diagnosis of ACS (UA/NSTEMI or STEMI) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitals with the capacity to perform cardiac catheterizations and PCIs will be identified. Sites will be further qualified based upon the expectation of an adequate number of ACS patients and the known or potential use of fondaparinux by the site. A minimum of 5 sites per country will be targeted in order to achieve a within-country representative sample. The study is planned for 7 countries in Europe and North America. Based on sample size estimates, approximately 32 physicians per country (6 to 7 per site) and approximately 256 patients per country (assuming an average of 8 patients per physician) will be targeted for inclusion, yielding a study total of approximately 1800 patients.
Key inclusion criteria (3 listed)
- Discharge diagnosis of ACS (UA/NSTEMI or STEMI)
- PCI during the hospitalization
- Anticoagulant treatment with fondaparinux
Key exclusion criteria (1 listed)
- Enrollment at the time of the index hospitalization in a clinical study that could influence ACS treatment practices, specifically the in-hospital use of anticoagulation
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 |
|---|---|---|
| fondaparinuxfondaparinux | Drug | Patients with a discharge diagnosis of ACS (UA/NSTEMI or STEMI |
Primary outcome
The proportion of patients with ACS treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI)
Time frame: ACS hospitalizations that occur at least one month after the availability of reimbursement for fondaparinux for the UA/NSTEMI and STEMI indications at that particular site are eligible
3 secondary outcomes
The proportion of patients with UA/NSTEMI treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI)
Time frame: ACS hospitalizations that occur at least one month after the availability of reimbursement for fondaparinux for the UA/NSTEMI and STEMI indications at that particular site are eligible
The proportion of patients with STEMI treated with fondaparinux, where fondaparinux is not administered prior to or during primary PCI
Time frame: ACS hospitalizations that occur at least one month after the availability of reimbursement for fondaparinux for the UA/NSTEMI and STEMI indications at that particular site are eligible
The proportion of patients with STEMI treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI)
Time frame: ACS hospitalizations that occur at least one month after the availability of reimbursement for fondaparinux for the UA/NSTEMI and STEMI indications at that particular site are eligible
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 Apr 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 Acute Coronary Syndrome, 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 Apr 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 proportion of patients with ACS treated with fondaparinux, for whom the prescribing information during PCI was followed (i.e., adjunctive anticoagulant therapy administered at the time of PCI) (time frame: ACS hospitalizations that occur at least one month after the availability of reimbursement for fondaparinux for the UA/NSTEMI and STEMI indications at that particular site are eligible). 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 Apr 2015.