Fondaparinux EU-RMP (Adherence)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01406301
First received: July 28, 2011
Last updated: September 1, 2011
Last verified: August 2011

July 28, 2011
September 1, 2011
March 2008
July 2011   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01406301 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Fondaparinux EU-RMP (Adherence)
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
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.

  • ST-elevation Myocardial Infarction
  • Unstable Angina
  • Non ST Segment Elevation Myocardial Infarction
  • Acute Coronary Syndrome
Drug: fondaparinux
fondaparinux
Patients with a discharge diagnosis of ACS (UA/NSTEMI or STEMI
Patients with a discharge diagnosis of ACS (UA/NSTEMI or STEMI)
Intervention: Drug: fondaparinux
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
0
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01406301
113652, WEUSRTP2284, EPI40495
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP