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
Phase:
Phase 3
Details
Lead Sponsor:
GlaxoSmithKline
Collaborators:
Duke University Organon Sanofi University of Chicago