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

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

Conditions

• Acute Coronary Syndrome

Interventions

DRUG

Otamixaban

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

Placebo (for Otamixaban)

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

UFH

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

Placebo (for UFH)

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

Eptifibatide

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

Placebo (for Eptifibatide)

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

Sponsors & Collaborators

• Sanofi

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-04-30

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• United States
• 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
• Vietnam

Study Locations