Fondaparinux EU-RMP (Adherence)

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fondaparinux

Drug

fondaparinux

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluate (Post Approval) the Adherence to the Prescribing Information for ARIXTRA® (Fondaparinux) in ACS Patients- Commitment of the Fondaparinux EU-RMP

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Aug 1, 2011
Registry last updated: Apr 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed