Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139815
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2005-08-29
Brief Title:
Michelangelo - Oasis 5
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An International Randomized Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable AnginaNon ST-segment Elevation MI Acute Coronary Syndromes
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:
Study Objectives
PRIMARY OBJECTIVE To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable anginanon ST-segment elevation myocardial infarction concurrently managed with standard medical therapy
SECONDARY OBJECTIVE If non inferiority of fondaparinux is established on initial statistical analysis in a second step superiority of fondaparinux to enoxaparin will be evaluated statistically
To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9
To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9
To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14 Day 30 Day 90 and Day 180
Study Drug Patients will be randomized to receive either
Fondaparinux 25 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
Enoxaparin 1mgkg twice and fondaparinux-placebo once daily by subcutaneous injection
Duration of Therapy
Fondaparinux 25mg daily for 8 days or hospital discharge whichever is earlier
Enoxaparin 1mgkg bid x 2-8 days or until clinically stable
Patients should receive an ASA and all other standard medical therapies
Substudy
A substudy comparing routine early coronary angiography immediately or as soon as possible but no later than 24 hours after randomization and intervention versus delayed 48 hrs coronary angiography and intervention
Primary Outcome The first occurence of any component of the following composite up to Day 9
Death
Myocardial Infarction
Refractory Ischemia
PRIMARY OBJECTIVE To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable anginanon ST-segment elevation myocardial infarction concurrently managed with standard medical therapy
SECONDARY OBJECTIVE If non inferiority of fondaparinux is established on initial statistical analysis in a second step superiority of fondaparinux to enoxaparin will be evaluated statistically
To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9
To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9
To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14 Day 30 Day 90 and Day 180
Study Drug Patients will be randomized to receive either
Fondaparinux 25 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
Enoxaparin 1mgkg twice and fondaparinux-placebo once daily by subcutaneous injection
Duration of Therapy
Fondaparinux 25mg daily for 8 days or hospital discharge whichever is earlier
Enoxaparin 1mgkg bid x 2-8 days or until clinically stable
Patients should receive an ASA and all other standard medical therapies
Substudy
A substudy comparing routine early coronary angiography immediately or as soon as possible but no later than 24 hours after randomization and intervention versus delayed 48 hrs coronary angiography and intervention
Primary Outcome The first occurence of any component of the following composite up to Day 9
Death
Myocardial Infarction
Refractory Ischemia
Detailed Description:
This is a double-blind double-dummy randomized parallel-group controlled trial to compare the safety and efficacy of fondaparinux and enoxaparin in subjects with UANSTEMI unstable anginanon ST segment myocardial infarction Study drug sc was started immediately following randomization subjects received fondaparinux 25mg once daily sc for 8 days or until hospital discharge if earlier or enoxaparin 1mgkg twice daily sc for 2 to 8 days or until clinically stable In subjects with creatinine clearance between 20mLmin and 30mLmin enoxaparin was administered as 1mgkg once daily In addition to study drug subjects were to receive standard medical care including interventions PCI percutaneous coronary intervention or coronary artery bypass graft surgery CABG
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