Michelangelo - Oasis 5
- Registration Number
- NCT00139815
- Lead Sponsor
- GlaxoSmithKline
- 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 angina/non 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 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
* Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection
Duration of Therapy:
* Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)
* Enoxaparin 1mg/kg b.i.d. 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 UA/NSTEMI (unstable angina/non ST segment myocardial infarction). Study drug (s.c.) was started immediately following randomization; subjects received fondaparinux 2.5mg once daily s.c for 8 days or until hospital discharge, if earlier, or enoxaparin 1mg/kg twice daily s.c for 2 to 8 days or until clinically stable. In subjects with creatinine clearance between 20mL/min and 30mL/min, enoxaparin was administered as 1mg/kg 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 \[CABG\]).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20078
- Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome.
- Able to randomize within 24 hours of the onset of the most recent episode of symptoms.
- At least one of the following additional criteria: (1) Troponin T of I or CK-MB above the upper limit of normal for the local institution and/or (2) ECG changes compatible with ischemia
- Written informed consent
- Age < 21 years
- Any contraindication to low molecular weight heparin
- Hemorrhagic stroke within the last 12 months
- Indication for anticoagulation other than ACS.
- Pregnancy or women of childbearing potential who are not using an effective method of contraception
- Co-morbid condition with life expectancy less than 6 months
- Prior enrollment in one of the fondaparinux ACS trails or currently receiving an experimental pharmacologic agent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enoxaparin enoxaparin - Fondaparinux Fondaparinux -
- Primary Outcome Measures
Name Time Method death, myocardial infarction or refractory up to and including Day 9 first occurrence of any component of death, myocardial infarction or
major bleeding Up to Day 9 incidence of adjudicated major bleeding
- Secondary Outcome Measures
Name Time Method Death, myocardial infarction or refractory up to Day 9, Day 14, Day 30, Incidence of the individual components of death, myocardial
Severe bleeding complications up to and including Day 9, Day Severe bleeding complications according to modified thrombolysis in
major bleeding up to and including Day 14, Day incidence of adjudicated major bleeding
Any bleeding (major or minor) up to and including Day 9, Day Any bleeding (major or minor) as reported by the investigator as
Death, myocardial infarction up to Days 9, 14, 30, 90 and composite of death, myocardial infarction