NCT00139815

Michelangelo - Oasis 5

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20,078 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 \[CABG\]).

Conditions

• Thromboembolism

Interventions

Type	Name	Description
DRUG	Fondaparinux	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
DRUG	enoxaparin	enoxaparin 1mg/kg s.c. injection twice daily x 2 to 8 days

Timeline

• Start date: 2003-04-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2005-08-31
• Last updated: 2016-09-15