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
Up to the interim analysis, patients are randomized to one of the Otamixaban arms or the control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized to the continued Otamixaban arm (per Data Monitoring Committee (DMC) decision based on interim analysis results) or the control arm (UFH + Eptifibatide). Except the DMC, all participants will remain blinded to this decision until the end of study. The total duration of the study period per subject will range between 30 days and 180 days. Study end date being the Day 30 visit of the last randomized patient, follow up will be until Day 180 or study end date whichever comes first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
13,220
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Investigational Site Number 840015
Huntsville, Alabama, United States
Investigational Site Number 840569
Phoenix, Arizona, United States
Investigational Site Number 840703
Phoenix, Arizona, United States
Investigational Site Number 840101
Anaheim, California, United States
Investigational Site Number 840151
Anaheim, California, United States
Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction
Time frame: from randomization (day 1) to day 7
Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)
Time frame: from day 1 to day 7
Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke
Time frame: from day 1 to day 7
Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction
Time frame: from day 1 to day 30
Adjudicated all-cause death
Time frame: from day 1 to day 30
Adjudicated Procedural thrombotic complications during the index PCI
Time frame: during index PCI
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Investigational Site Number 840213
Beverly Hills, California, United States
Investigational Site Number 840572
Huntington Beach, California, United States
Investigational Site Number 840201
Long Beach, California, United States
Investigational Site Number 840071
Los Angeles, California, United States
Investigational Site Number 840557
Los Angeles, California, United States
...and 597 more locations