Fondaparinux EU-RMP (Adherence)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
ST-elevation Myocardial Infarction Unstable Angina Non ST Segment Elevation Myocardial Infarction Acute Coronary Syndrome |
Drug: fondaparinux |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Evaluate (Post Approval) the Adherence to the Prescribing Information for ARIXTRA® (Fondaparinux) in ACS Patients- Commitment of the Fondaparinux EU-RMP |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | March 2008 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients with a discharge diagnosis of ACS (UA/NSTEMI or STEMI
Patients with a discharge diagnosis of ACS (UA/NSTEMI or STEMI)
|
Drug: fondaparinux
fondaparinux
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Discharge diagnosis of ACS (UA/NSTEMI or STEMI)
- PCI during the hospitalization
- Anticoagulant treatment with fondaparinux
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01406301 History of Changes |
| Other Study ID Numbers: | 113652, WEUSRTP2284, EPI40495 |
| Study First Received: | July 28, 2011 |
| Last Updated: | September 1, 2011 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
prescribing information |
Additional relevant MeSH terms:
|
Angina, Unstable Infarction Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Ischemia |
Pathologic Processes Necrosis 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 19, 2013