Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01406301
Status:
COMPLETED
Last Update Posted:
2015-04-27
First Post:
2011-07-28
Brief Title:
Fondaparinux EU-RMP Adherence
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate Post Approval the Adherence to the Prescribing Information for ARIXTRA Fondaparinux in ACS Patients- Commitment of the Fondaparinux EU-RMP
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 UANSTEMI 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 ie 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
ARIXTRA is a trademark of the GlaxoSmithKline group of companies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPI40495 | OTHER | GSK | None |
| WEUSRTP2284 | OTHER | None | None |