Michelangelo - Oasis 5
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|ClinicalTrials.gov Identifier: NCT00139815|
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : September 15, 2016
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.
- 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:
- Myocardial Infarction
- Refractory Ischemia
|Condition or disease||Intervention/treatment||Phase|
|Thromboembolism||Drug: Fondaparinux Drug: enoxaparin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20078 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||April 2003|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
|Active Comparator: Enoxaparin||
enoxaparin 1mg/kg s.c. injection twice daily x 2 to 8 days
fondaparinux 2.5 mg, s.c. injection once daily x 8 days or Hospital Discharge if earlier and placebo-enoxaparin 1mg/kg s.c. injection twice daily x 2-8 days or until clinically stable
- death, myocardial infarction or refractory [ Time Frame: up to and including Day 9 ]first occurrence of any component of death, myocardial infarction or
- major bleeding [ Time Frame: Up to Day 9 ]incidence of adjudicated major bleeding
- Death, myocardial infarction or refractory [ Time Frame: up to Day 9, Day 14, Day 30, ]Incidence of the individual components of death, myocardial
- major bleeding [ Time Frame: up to and including Day 14, Day ]incidence of adjudicated major bleeding
- Any bleeding (major or minor) [ Time Frame: up to and including Day 9, Day ]Any bleeding (major or minor) as reported by the investigator as
- Severe bleeding complications [ Time Frame: up to and including Day 9, Day ]Severe bleeding complications according to modified thrombolysis in
- Death, myocardial infarction [ Time Frame: up to Days 9, 14, 30, 90 and ]composite of death, myocardial infarction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139815
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|