NCT01076764|CompletedPhase 3DMC

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

TAO

Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of Otamixaban With Unfractionated Heparin + Eptifibatide, in Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy

Sanofi ClinicalTrials.gov

Compare

2 other identifiers

EFC62042009-016568-36

Study Type

interventional

Target

13,220

Locations

50 countries

Sites

588

Timeline

RegisteredFeb 2010

StartedApr 2010

CompletionMay 2013

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

13,220

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Apr 2010

Typical duration for phase_3

Geographic Reach

50 countries

588 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

First Submitted

Initial submission to the registry

February 25, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed

1 month until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed

Last Updated

May 4, 2016

Status Verified

April 1, 2016

Enrollment Period

3.1 years

First QC Date

February 25, 2010

Last Update Submit

April 4, 2016

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

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 Outcomes (4)

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 all-cause death
from day 1 to day 30
Adjudicated Procedural thrombotic complications during the index PCI
during index PCI

Study Arms (3)

Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion

EXPERIMENTAL

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)

Drug: OtamixabanDrug: Placebo (for UFH)Drug: Placebo (for Eptifibatide)

Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion

EXPERIMENTAL

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)

Drug: OtamixabanDrug: Placebo (for UFH)Drug: Placebo (for Eptifibatide)

UFH + Eptifibatide

ACTIVE COMPARATOR

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)

Drug: Placebo (for Otamixaban)Drug: UFHDrug: Eptifibatide