Ignite Creation Date:
2024-05-05 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00790907
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2008-11-13
Brief Title:
Fondaparinux Trial With Unfractionated Heparin UFH During Revascularization in Acute Coronary Syndromes ACS
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
FondaparinUx Trial With Unfractionated Heparin UFH During Revascularization in Acute Coronary Syndromes ACS FUTURA A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH During PCI in High Risk Patients With Unstable AnginaNon ST Segment Elevation Myocardial Infarction UANSTEMI Initially Treated With Subcutaneous Fondaparinux and Referred for Early Coronary Angiography OASIS 8
Status:
COMPLETED
Status Verified Date:
2017-03
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:
FUTURAOASIS 8
Brief Summary:
The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin UFH during a percutaneous coronary intervention PCI procedure in patients with UA unstable anginaNSTEMI non ST segment elevation myocardial infarction who have been initially treated with fondaparinux
Detailed Description:
Subjects presenting at hospital with suspected UA or NSTEMI and who are likely to undergo angiography ideally within 72 hours will be assessed for eligibility and consented Suitable subjects will be enrolled and commence treatment with open-label fondaparinux 25 milligram mg subcutaneous sc once daily Following angiography subjects indicated for PCI and meeting the additional requirements for randomization will be randomised to receive one of two dose regimens of UFH either standard dose or low dose immediately prior to the PCI procedure Post-PCI therapy with fondaparinux 25 mg sc may be resumed at the investigators discretion for up to a maximum of 8 days or hospital discharge whichever is earlier
Subjects not indicated for PCI will continue treatment with fondaparinux 25mg sc once daily for up to 8 days or hospital discharge whichever is earlier
All subjects will be followed up for 30 days after randomizationangiography
Subjects not indicated for PCI will continue treatment with fondaparinux 25mg sc once daily for up to 8 days or hospital discharge whichever is earlier
All subjects will be followed up for 30 days after randomizationangiography
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