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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01076764




Registration number
NCT01076764
Ethics application status
Date submitted
25/02/2010
Date registered
26/02/2010
Date last updated
4/05/2016

Titles & IDs
Public title
Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy
Scientific title
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
Secondary ID [1] 0 0
2009-016568-36
Secondary ID [2] 0 0
EFC6204
Universal Trial Number (UTN)
Trial acronym
TAO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Otamixaban
Treatment: Drugs - Placebo (for Otamixaban)
Treatment: Drugs - UFH
Treatment: Drugs - Placebo (for UFH)
Treatment: Drugs - Eptifibatide
Treatment: Drugs - Placebo (for Eptifibatide)

Experimental: Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusion - 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)

Experimental: Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusion - 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)

Active Comparator: UFH + 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)


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

Treatment: Drugs: Placebo (for Otamixaban)
Pharmaceutical form: Intravenous (IV) solution
Route of administration: IV bolus followed by continuous IV infusion

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

Treatment: Drugs: Placebo (for UFH)
Pharmaceutical form: Intravenous (IV) solution
Route of administration: IV bolus followed by continuous IV infusion

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

Treatment: Drugs: Placebo (for Eptifibatide)
Pharmaceutical form: Intravenous (IV) solution
Route of administration: IV bolus followed by continuous IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction
Timepoint [1] 0 0
from randomization (day 1) to day 7
Primary outcome [2] 0 0
Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)
Timepoint [2] 0 0
from day 1 to day 7
Secondary outcome [1] 0 0
Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke
Timepoint [1] 0 0
from day 1 to day 7
Secondary outcome [2] 0 0
Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction
Timepoint [2] 0 0
from day 1 to day 30
Secondary outcome [3] 0 0
Adjudicated all-cause death
Timepoint [3] 0 0
from day 1 to day 30
Secondary outcome [4] 0 0
Adjudicated Procedural thrombotic complications during the index PCI
Timepoint [4] 0 0
during index PCI

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
13220
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036008 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 036004 - Ballarat
Recruitment hospital [3] 0 0
Investigational Site Number 036010 - Concord
Recruitment hospital [4] 0 0
Investigational Site Number 036001 - Herston
Recruitment hospital [5] 0 0
Investigational Site Number 036913 - Hobart
Recruitment hospital [6] 0 0
Investigational Site Number 036011 - Liverpool
Recruitment hospital [7] 0 0
Investigational Site Number 036003 - Prahran
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3353 - Ballarat
Recruitment postcode(s) [3] 0 0
2137 - Concord
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
7001 - Hobart
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
3004 - Prahran
Recruitment outside Australia
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Ho Chi Minh City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01076764
Trial related presentations / publications
Steg PG, Mehta SR, Pollack CV Jr, Bode C, Gaudin C, Fanouillere K, Moryusef A, Wiviott SD, Sabatine MS. Design and rationale of the treatment of acute coronary syndromes with otamixaban trial: a double-blind triple-dummy 2-stage randomized trial comparing otamixaban to unfractionated heparin and eptifibatide in non-ST-segment elevation acute coronary syndromes with a planned early invasive strategy. Am Heart J. 2012 Dec;164(6):817-24.e13. doi: 10.1016/j.ahj.2012.10.001. Epub 2012 Nov 7.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01076764