Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064428
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2003-07-08
Brief Title:
OASIS-6 The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2016-09
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:
This is a randomized double blindcontrolled parallel group multi-center multinational study of fondaparinux vs control in patients with STEMI ST segment myocardial infarction randomized within 24 hours of the onset of symptoms
Detailed Description:
This is a randomized double blind controlled parallel group multi-center multinational study of fondaparinux vs control in patients with STEMI randomized within 24 hours of the onset of symptoms Patients with confirmed STEMI were assigned into one of the following strata based on local preference
Stratum 1 No indication for UFH it is generally accepted that patients receiving streptokinase or those not receiving a thrombolytic agent were assigned to this stratum
Stratum 2 Indication for UFH it is generally accepted that patients receiving a fibrin-specific agent such as alteplase reteplase or tenecteplase or those undergoing primary PCI were assigned to this stratum
Patients who were ineligible for fibrinolysis eg because of late presentation or absolute contra-indication for reperfusion therapy may fall into either stratum 1 or stratum 2 at investigators discretion Following allocation to one of the strata patients were randomized to fondaparinux or control treatment Control treatment was dependent on whether the patient was assigned to stratum 1 or stratum 2
Stratum 1 fondaparinux sc versus fondaparinux-placebo sc for 8 days or until hospital discharge whichever was earlier
Stratum 2 fondaparinux sc for 8 days or until hospital discharge whichever was earlier and UFH-placebo for 24 to 48 hrs or single bolus injection immediately prior to procedure in case of primary PCI versus UFH for 24 to 48 hrs or single bolus injection immediately prior to procedure in case of primary PCI and fondaparinux-placebo for 8 days or until hospital discharge whichever was earlier
First dose intravenous bolus Patients were followed up for 6 months
Stratum 1 No indication for UFH it is generally accepted that patients receiving streptokinase or those not receiving a thrombolytic agent were assigned to this stratum
Stratum 2 Indication for UFH it is generally accepted that patients receiving a fibrin-specific agent such as alteplase reteplase or tenecteplase or those undergoing primary PCI were assigned to this stratum
Patients who were ineligible for fibrinolysis eg because of late presentation or absolute contra-indication for reperfusion therapy may fall into either stratum 1 or stratum 2 at investigators discretion Following allocation to one of the strata patients were randomized to fondaparinux or control treatment Control treatment was dependent on whether the patient was assigned to stratum 1 or stratum 2
Stratum 1 fondaparinux sc versus fondaparinux-placebo sc for 8 days or until hospital discharge whichever was earlier
Stratum 2 fondaparinux sc for 8 days or until hospital discharge whichever was earlier and UFH-placebo for 24 to 48 hrs or single bolus injection immediately prior to procedure in case of primary PCI versus UFH for 24 to 48 hrs or single bolus injection immediately prior to procedure in case of primary PCI and fondaparinux-placebo for 8 days or until hospital discharge whichever was earlier
First dose intravenous bolus Patients were followed up for 6 months
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