DRUG
Otamixaban
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Status
Completed
Phase
Phase 3
Enrollment
13,220
Locations
607
Results
Not posted
Publications
5
Study summary
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.
Interventions
DRUG
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
DRUG
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
DRUG
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
DRUG
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
DRUG
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
DRUG
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
Timeline
First posted
Feb 26, 2010
Study start
Apr 2010
Primary completion
May 2013
Study completion
May 2013
Results posted
Not reported
Registry updated
May 4, 2016
Outcomes
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
Eligibility
Inclusion criteria: Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) with: 1. Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization, AND 2. One of the two following criteria: * New ST-segment depression ≥ 0.1 mV (≥1 mm), or transient (\< 30 minutes) ST-segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads on the electrocardiogram, * Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal, AND 3. Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified), AND 4. Informed consent obtained in writing. Exclusion criteria: * Revascularization procedure already performed for the qualifying event Acute ST-segment elevation MI. * Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization or who have been treated by abciximab. * Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing. * Patient who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling. * Patient who cannot be treated with eptifibatide according to the national labeling (when available). In countries where eptifibatide is not approved the reference label to be considered is either the European labeling or the US labeling * Patient who cannot be treated with unfractionated heparin according to the national labeling. * Allergy to otamixaban. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study locations
Argentina · Australia · Austria · Belarus · Belgium · Brazil · Bulgaria · Canada · Chile · Colombia · Croatia · Czechia · Egypt · Estonia · France · Germany · Greece · Hong Kong · Hungary · India · Indonesia · Israel · Italy · Jordan · Latvia · Lebanon · Lithuania · Malaysia · Mexico · Montenegro · Netherlands · New Zealand · North Macedonia · Norway · Panama · Peru · Poland · Portugal · Romania · Russia · Serbia · Singapore · Slovakia · South Africa · South Korea · Spain · Switzerland · Taiwan · Thailand · Tunisia · Turkey (Türkiye) · Ukraine · United Kingdom · United States · Vietnam. Showing up to 24 locations stored in the fast local snapshot.
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
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
Investigational Site Number 840903
Northridge, California, United States
Investigational Site Number 840065
San Francisco, California, United States
Investigational Site Number 840561
Santa Rosa, California, United States
Investigational Site Number 840721
Littleton, Colorado, United States
Investigational Site Number 840551
Bridgeport, Connecticut, United States
Investigational Site Number 840166
New Haven, Connecticut, United States
Investigational Site Number 840520
Washington D.C., District of Columbia, United States
Investigational Site Number 840185
Fort Lauderdale, Florida, United States
Investigational Site Number 840028
Jacksonville, Florida, United States
Investigational Site Number 840047
Lake Mary, Florida, United States
Investigational Site Number 840500
Melbourne, Florida, United States
Investigational Site Number 840706
Miami, Florida, United States
Investigational Site Number 840009
Ocala, Florida, United States
Investigational Site Number 840146
Ocala, Florida, United States
Publications
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