Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

Phase 3

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Otamixaban; Drug: Placebo (for Otamixaban); Drug: Placebo (for UFH); Drug: UFH; Drug: Placebo (for Eptifibatide); Drug: Eptifibatide

• Registration Number: NCT01076764
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

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 Timeline

• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Study Start: 2010-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-04
• Disposition First Submitted QC: 2016-04-04
• Last Update Submitted: 2016-04-04
• Disposition First Posted: 2016-05-04
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion	Placebo (for UFH)	From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion	Placebo (for Eptifibatide)	From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion	Otamixaban	From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion	Placebo (for UFH)	From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion	Placebo (for Eptifibatide)	From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban 0.080 mg/kg bolus followed by 0.140 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
UFH + Eptifibatide	UFH	From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Placebo (for Otamixaban) * Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion	Otamixaban	From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Otamixaban (0.080 mg/kg bolus followed by 0.100 mg/kg/h infusion) * Drug B: Placebo (for UFH) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Placebo (for Eptifibatide)
UFH + Eptifibatide	Placebo (for Otamixaban)	From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Placebo (for Otamixaban) * Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)
UFH + Eptifibatide	Eptifibatide	From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first: * Drug A: Placebo (for Otamixaban) * Drug B: UFH (60 IU/kg bolus followed by 12 IU/kg/h infusion) From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first: * Drug C: Eptifibatide (180 mcg/kg bolus followed by 2 mcg/kg/min infusion)

Primary Outcome Measures

Name	Time	Method
Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction	from randomization (day 1) to day 7
Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)	from day 1 to day 7

Secondary Outcome Measures

Name	Time	Method
Adjudicated all-cause death	from day 1 to day 30
Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke	from day 1 to day 7
Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction	from day 1 to day 30
Adjudicated Procedural thrombotic complications during the index PCI	during index PCI

Trial Locations

Locations (607)

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; 🇺🇸 Beverley 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

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