The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
Completed
Sanofi
Phase 2
The objective of this dose-ranging study is to determine the effects of several intravenous
(IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and
coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
Completed
Sanofi
Phase 2
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5
intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute
coronary syndromes (ACS) and planned early invasive strategy.
Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and
pharmacodynamics (PD).
Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy
Completed
Sanofi
Phase 3
Primary Objective:
- To demonstrate the superior efficacy (composite of all-cause death + Myocardial
Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide
Secondary Objectives:
- To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of
Otamixaban as compared to UFH + Eptifibatide
- To document the effect of Otamixaban on rehospitalization or prolongation of
hospitalization due to a new episode of myocardial ischemia/myocardial infarction as
compared to UFH + eptifibatide
- To document the effect on mortality (all cause death) of Otamixaban as compared to UFH +
eptifibatide
- To document the safety of Otamixaban as compared to UFH + eptifibatide
- To document the effect of Otamixaban on thrombotic procedural complications during the
index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide
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