Michelangelo - Oasis 5
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Infarction
Intervention: Fondaparinux (Drug); enoxaparin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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
Clinical Details
Official title: An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: death, myocardial infarction or refractorymajor bleeding
Secondary outcome: Death, myocardial infarction or refractorymajor bleeding Any bleeding (major or minor) Severe bleeding complications Death, myocardial infarction
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]).
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: March 2003
Last updated: October 13, 2011
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