The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kansas
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Montana
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
North Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Oregon
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Argentina
State/province [35] 0 0
Adrogue
Country [36] 0 0
Argentina
State/province [36] 0 0
Avellaneda
Country [37] 0 0
Argentina
State/province [37] 0 0
Buenos Aires
Country [38] 0 0
Argentina
State/province [38] 0 0
Caba
Country [39] 0 0
Argentina
State/province [39] 0 0
Capital Federal
Country [40] 0 0
Argentina
State/province [40] 0 0
Ciudad Autonoma De Bs.As
Country [41] 0 0
Argentina
State/province [41] 0 0
Ciudad De Buenos Aires
Country [42] 0 0
Argentina
State/province [42] 0 0
Cordoba
Country [43] 0 0
Argentina
State/province [43] 0 0
Corrientes
Country [44] 0 0
Argentina
State/province [44] 0 0
Florencio Varela
Country [45] 0 0
Argentina
State/province [45] 0 0
La Plata
Country [46] 0 0
Argentina
State/province [46] 0 0
Mendoza
Country [47] 0 0
Argentina
State/province [47] 0 0
Olivos
Country [48] 0 0
Argentina
State/province [48] 0 0
Pilar
Country [49] 0 0
Argentina
State/province [49] 0 0
Resistencia
Country [50] 0 0
Argentina
State/province [50] 0 0
Rosario
Country [51] 0 0
Argentina
State/province [51] 0 0
San Luis
Country [52] 0 0
Argentina
State/province [52] 0 0
San Martin
Country [53] 0 0
Argentina
State/province [53] 0 0
San Miguel De Tucuman
Country [54] 0 0
Argentina
State/province [54] 0 0
Santa Fe
Country [55] 0 0
Austria
State/province [55] 0 0
Wien
Country [56] 0 0
Belarus
State/province [56] 0 0
Gomel
Country [57] 0 0
Belarus
State/province [57] 0 0
Minsk
Country [58] 0 0
Belgium
State/province [58] 0 0
Bonheiden
Country [59] 0 0
Belgium
State/province [59] 0 0
Brugge
Country [60] 0 0
Belgium
State/province [60] 0 0
Brussels
Country [61] 0 0
Belgium
State/province [61] 0 0
Haine-Saint-Paul
Country [62] 0 0
Belgium
State/province [62] 0 0
Leuven
Country [63] 0 0
Brazil
State/province [63] 0 0
Campinas
Country [64] 0 0
Brazil
State/province [64] 0 0
Fortaleza
Country [65] 0 0
Brazil
State/province [65] 0 0
Marilia
Country [66] 0 0
Brazil
State/province [66] 0 0
Maringa
Country [67] 0 0
Brazil
State/province [67] 0 0
Passo Fundo
Country [68] 0 0
Brazil
State/province [68] 0 0
Porto Alegre
Country [69] 0 0
Brazil
State/province [69] 0 0
Recife
Country [70] 0 0
Brazil
State/province [70] 0 0
Rio De Janeiro
Country [71] 0 0
Brazil
State/province [71] 0 0
Salvador
Country [72] 0 0
Brazil
State/province [72] 0 0
Sao Jose Do Rio Preto
Country [73] 0 0
Brazil
State/province [73] 0 0
Sao Paulo
Country [74] 0 0
Brazil
State/province [74] 0 0
Uberlandia
Country [75] 0 0
Brazil
State/province [75] 0 0
Votuporanga
Country [76] 0 0
Bulgaria
State/province [76] 0 0
Blagoevgrad
Country [77] 0 0
Bulgaria
State/province [77] 0 0
Kazanlak
Country [78] 0 0
Bulgaria
State/province [78] 0 0
Pazardjik
Country [79] 0 0
Bulgaria
State/province [79] 0 0
Pleven
Country [80] 0 0
Bulgaria
State/province [80] 0 0
Ruse
Country [81] 0 0
Bulgaria
State/province [81] 0 0
Sandanski
Country [82] 0 0
Bulgaria
State/province [82] 0 0
Sofia
Country [83] 0 0
Bulgaria
State/province [83] 0 0
Varna
Country [84] 0 0
Bulgaria
State/province [84] 0 0
Veliko Tarnovo
Country [85] 0 0
Bulgaria
State/province [85] 0 0
Yambol
Country [86] 0 0
Canada
State/province [86] 0 0
Gatineau
Country [87] 0 0
Canada
State/province [87] 0 0
Hamilton
Country [88] 0 0
Canada
State/province [88] 0 0
Montreal
Country [89] 0 0
Canada
State/province [89] 0 0
Quebec
Country [90] 0 0
Canada
State/province [90] 0 0
Sherbrooke
Country [91] 0 0
Canada
State/province [91] 0 0
St. John
Country [92] 0 0
Canada
State/province [92] 0 0
Toronto
Country [93] 0 0
Chile
State/province [93] 0 0
Antofagasta
Country [94] 0 0
Chile
State/province [94] 0 0
Concepcion
Country [95] 0 0
Chile
State/province [95] 0 0
Iquique
Country [96] 0 0
Chile
State/province [96] 0 0
Santiago
Country [97] 0 0
Chile
State/province [97] 0 0
Talcahuano
Country [98] 0 0
Chile
State/province [98] 0 0
Temuco
Country [99] 0 0
Chile
State/province [99] 0 0
Valdivia
Country [100] 0 0
Chile
State/province [100] 0 0
Valparaíso
Country [101] 0 0
Chile
State/province [101] 0 0
Vina Del Mar
Country [102] 0 0
Chile
State/province [102] 0 0
Viña Del Mar
Country [103] 0 0
Colombia
State/province [103] 0 0
Barranquilla
Country [104] 0 0
Colombia
State/province [104] 0 0
Bogota
Country [105] 0 0
Colombia
State/province [105] 0 0
Bogotá
Country [106] 0 0
Colombia
State/province [106] 0 0
Bucaramanga
Country [107] 0 0
Colombia
State/province [107] 0 0
Cali
Country [108] 0 0
Colombia
State/province [108] 0 0
Medellin
Country [109] 0 0
Croatia
State/province [109] 0 0
Slavonski Brod
Country [110] 0 0
Croatia
State/province [110] 0 0
Zagreb
Country [111] 0 0
Czech Republic
State/province [111] 0 0
Brno
Country [112] 0 0
Czech Republic
State/province [112] 0 0
Hradec Kralove
Country [113] 0 0
Czech Republic
State/province [113] 0 0
Liberec
Country [114] 0 0
Czech Republic
State/province [114] 0 0
Olomouc
Country [115] 0 0
Czech Republic
State/province [115] 0 0
Ostrava - Poruba
Country [116] 0 0
Czech Republic
State/province [116] 0 0
Praha 10
Country [117] 0 0
Czech Republic
State/province [117] 0 0
Praha 2
Country [118] 0 0
Czech Republic
State/province [118] 0 0
Praha 5
Country [119] 0 0
Czech Republic
State/province [119] 0 0
Usti Nad Labem
Country [120] 0 0
Czech Republic
State/province [120] 0 0
Zlin
Country [121] 0 0
Egypt
State/province [121] 0 0
Cairo
Country [122] 0 0
Egypt
State/province [122] 0 0
Giza
Country [123] 0 0
Estonia
State/province [123] 0 0
Tallinn
Country [124] 0 0
France
State/province [124] 0 0
Avignon Cedex 2
Country [125] 0 0
France
State/province [125] 0 0
Bayonne
Country [126] 0 0
France
State/province [126] 0 0
Belfort Cedex
Country [127] 0 0
France
State/province [127] 0 0
Besancon
Country [128] 0 0
France
State/province [128] 0 0
Creteil
Country [129] 0 0
France
State/province [129] 0 0
Dijon Cedex
Country [130] 0 0
France
State/province [130] 0 0
Le Chesnay Cedex
Country [131] 0 0
France
State/province [131] 0 0
Montfermeil
Country [132] 0 0
France
State/province [132] 0 0
Mulhouse
Country [133] 0 0
France
State/province [133] 0 0
Paris
Country [134] 0 0
France
State/province [134] 0 0
Pau
Country [135] 0 0
France
State/province [135] 0 0
Rouen
Country [136] 0 0
France
State/province [136] 0 0
Strasbourg
Country [137] 0 0
France
State/province [137] 0 0
Toulouse Cedex 9
Country [138] 0 0
Germany
State/province [138] 0 0
Berlin
Country [139] 0 0
Germany
State/province [139] 0 0
Bonn
Country [140] 0 0
Germany
State/province [140] 0 0
Frankfurt Am Main
Country [141] 0 0
Germany
State/province [141] 0 0
Freiburg
Country [142] 0 0
Germany
State/province [142] 0 0
Hamburg
Country [143] 0 0
Germany
State/province [143] 0 0
Heidelberg
Country [144] 0 0
Germany
State/province [144] 0 0
Heidenheim
Country [145] 0 0
Germany
State/province [145] 0 0
Kassel
Country [146] 0 0
Germany
State/province [146] 0 0
Langen
Country [147] 0 0
Germany
State/province [147] 0 0
Mainz
Country [148] 0 0
Germany
State/province [148] 0 0
Mönchengladbach
Country [149] 0 0
Germany
State/province [149] 0 0
München
Country [150] 0 0
Germany
State/province [150] 0 0
Rostock
Country [151] 0 0
Greece
State/province [151] 0 0
Alexandroupolis
Country [152] 0 0
Greece
State/province [152] 0 0
Athens
Country [153] 0 0
Greece
State/province [153] 0 0
Chios
Country [154] 0 0
Greece
State/province [154] 0 0
Larissa
Country [155] 0 0
Greece
State/province [155] 0 0
Melissia
Country [156] 0 0
Greece
State/province [156] 0 0
N. Ionia
Country [157] 0 0
Greece
State/province [157] 0 0
Patras
Country [158] 0 0
Greece
State/province [158] 0 0
Thessaloniki
Country [159] 0 0
Hong Kong
State/province [159] 0 0
Chai Wan
Country [160] 0 0
Hungary
State/province [160] 0 0
Budapest
Country [161] 0 0
Hungary
State/province [161] 0 0
Szeged
Country [162] 0 0
Hungary
State/province [162] 0 0
Szekesfehervar
Country [163] 0 0
Hungary
State/province [163] 0 0
Szolnok
Country [164] 0 0
Hungary
State/province [164] 0 0
Szombathely
Country [165] 0 0
Hungary
State/province [165] 0 0
Zalaegerszeg
Country [166] 0 0
India
State/province [166] 0 0
Ahmedabad
Country [167] 0 0
India
State/province [167] 0 0
Allahabad
Country [168] 0 0
India
State/province [168] 0 0
Bangalore
Country [169] 0 0
India
State/province [169] 0 0
Chandigarh
Country [170] 0 0
India
State/province [170] 0 0
Gurgaon
Country [171] 0 0
India
State/province [171] 0 0
Hyderabad
Country [172] 0 0
India
State/province [172] 0 0
Jaipur
Country [173] 0 0
India
State/province [173] 0 0
Karamsad
Country [174] 0 0
India
State/province [174] 0 0
Kochi
Country [175] 0 0
India
State/province [175] 0 0
Kolkata
Country [176] 0 0
India
State/province [176] 0 0
Madurai
Country [177] 0 0
India
State/province [177] 0 0
Mangalore
Country [178] 0 0
India
State/province [178] 0 0
Mumbai
Country [179] 0 0
India
State/province [179] 0 0
Mysore
Country [180] 0 0
India
State/province [180] 0 0
Nagpur
Country [181] 0 0
India
State/province [181] 0 0
Nashik
Country [182] 0 0
India
State/province [182] 0 0
New Delhi
Country [183] 0 0
India
State/province [183] 0 0
Pune
Country [184] 0 0
India
State/province [184] 0 0
Secunderabad
Country [185] 0 0
India
State/province [185] 0 0
Varanasi
Country [186] 0 0
India
State/province [186] 0 0
Vijaywada
Country [187] 0 0
Indonesia
State/province [187] 0 0
Bandung
Country [188] 0 0
Indonesia
State/province [188] 0 0
Depok
Country [189] 0 0
Indonesia
State/province [189] 0 0
Jakarta
Country [190] 0 0
Israel
State/province [190] 0 0
Afula
Country [191] 0 0
Israel
State/province [191] 0 0
Ashkelon
Country [192] 0 0
Israel
State/province [192] 0 0
Hadera
Country [193] 0 0
Israel
State/province [193] 0 0
Haifa
Country [194] 0 0
Israel
State/province [194] 0 0
Holon
Country [195] 0 0
Israel
State/province [195] 0 0
Jerusalem
Country [196] 0 0
Israel
State/province [196] 0 0
Safed
Country [197] 0 0
Israel
State/province [197] 0 0
Tel Aviv
Country [198] 0 0
Israel
State/province [198] 0 0
Tel Hashomer
Country [199] 0 0
Israel
State/province [199] 0 0
Tzrifin
Country [200] 0 0
Italy
State/province [200] 0 0
Bergamo
Country [201] 0 0
Italy
State/province [201] 0 0
Bologna
Country [202] 0 0
Italy
State/province [202] 0 0
Brescia
Country [203] 0 0
Italy
State/province [203] 0 0
Castellanza
Country [204] 0 0
Italy
State/province [204] 0 0
Catania
Country [205] 0 0
Italy
State/province [205] 0 0
Cittadella
Country [206] 0 0
Italy
State/province [206] 0 0
Conegliano
Country [207] 0 0
Italy
State/province [207] 0 0
Empoli
Country [208] 0 0
Italy
State/province [208] 0 0
Forlì
Country [209] 0 0
Italy
State/province [209] 0 0
Livorno
Country [210] 0 0
Italy
State/province [210] 0 0
Massa
Country [211] 0 0
Italy
State/province [211] 0 0
Messina
Country [212] 0 0
Italy
State/province [212] 0 0
Milano
Country [213] 0 0
Italy
State/province [213] 0 0
Modena
Country [214] 0 0
Italy
State/province [214] 0 0
Napoli
Country [215] 0 0
Italy
State/province [215] 0 0
Perugia
Country [216] 0 0
Italy
State/province [216] 0 0
Pescara
Country [217] 0 0
Italy
State/province [217] 0 0
Pordenone
Country [218] 0 0
Italy
State/province [218] 0 0
Reggio Emilia
Country [219] 0 0
Italy
State/province [219] 0 0
Roma
Country [220] 0 0
Italy
State/province [220] 0 0
Rovigo
Country [221] 0 0
Italy
State/province [221] 0 0
Rozzano
Country [222] 0 0
Italy
State/province [222] 0 0
Seriate
Country [223] 0 0
Italy
State/province [223] 0 0
Treviso
Country [224] 0 0
Jordan
State/province [224] 0 0
Amman
Country [225] 0 0
Jordan
State/province [225] 0 0
Irbid
Country [226] 0 0
Korea, Republic of
State/province [226] 0 0
Busan
Country [227] 0 0
Korea, Republic of
State/province [227] 0 0
Daegu
Country [228] 0 0
Korea, Republic of
State/province [228] 0 0
Daejeon
Country [229] 0 0
Korea, Republic of
State/province [229] 0 0
Goyang
Country [230] 0 0
Korea, Republic of
State/province [230] 0 0
Guri
Country [231] 0 0
Korea, Republic of
State/province [231] 0 0
Gwangju
Country [232] 0 0
Korea, Republic of
State/province [232] 0 0
Seongnam
Country [233] 0 0
Korea, Republic of
State/province [233] 0 0
Seoul
Country [234] 0 0
Korea, Republic of
State/province [234] 0 0
Suwon
Country [235] 0 0
Korea, Republic of
State/province [235] 0 0
Wonju
Country [236] 0 0
Latvia
State/province [236] 0 0
Daugavpils
Country [237] 0 0
Latvia
State/province [237] 0 0
Liepaja
Country [238] 0 0
Latvia
State/province [238] 0 0
Riga
Country [239] 0 0
Lebanon
State/province [239] 0 0
Beirut
Country [240] 0 0
Lithuania
State/province [240] 0 0
Kaunas
Country [241] 0 0
Lithuania
State/province [241] 0 0
Siauliai
Country [242] 0 0
Lithuania
State/province [242] 0 0
Vilnius
Country [243] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [243] 0 0
Skopje
Country [244] 0 0
Malaysia
State/province [244] 0 0
Kuching
Country [245] 0 0
Mexico
State/province [245] 0 0
Aguascalientes
Country [246] 0 0
Mexico
State/province [246] 0 0
Guadalajara
Country [247] 0 0
Mexico
State/province [247] 0 0
Merida
Country [248] 0 0
Mexico
State/province [248] 0 0
Mexico City
Country [249] 0 0
Mexico
State/province [249] 0 0
Monterrey
Country [250] 0 0
Mexico
State/province [250] 0 0
Morelia, Michoacan
Country [251] 0 0
Mexico
State/province [251] 0 0
México Df
Country [252] 0 0
Mexico
State/province [252] 0 0
Puebla
Country [253] 0 0
Mexico
State/province [253] 0 0
Queretaro
Country [254] 0 0
Mexico
State/province [254] 0 0
San Luis Potosi
Country [255] 0 0
Mexico
State/province [255] 0 0
Xalapa
Country [256] 0 0
Montenegro
State/province [256] 0 0
Podgorica
Country [257] 0 0
Netherlands
State/province [257] 0 0
Alkmaar
Country [258] 0 0
Netherlands
State/province [258] 0 0
Arnhem
Country [259] 0 0
Netherlands
State/province [259] 0 0
Leeuwarden
Country [260] 0 0
Netherlands
State/province [260] 0 0
Nieuwegein
Country [261] 0 0
Netherlands
State/province [261] 0 0
Rotterdam
Country [262] 0 0
New Zealand
State/province [262] 0 0
Auckland
Country [263] 0 0
New Zealand
State/province [263] 0 0
Hamilton
Country [264] 0 0
New Zealand
State/province [264] 0 0
Nelson
Country [265] 0 0
Norway
State/province [265] 0 0
Arendal
Country [266] 0 0
Norway
State/province [266] 0 0
Bergen
Country [267] 0 0
Norway
State/province [267] 0 0
Stavanger
Country [268] 0 0
Panama
State/province [268] 0 0
Panama
Country [269] 0 0
Panama
State/province [269] 0 0
Panamá
Country [270] 0 0
Peru
State/province [270] 0 0
Lambayeque
Country [271] 0 0
Peru
State/province [271] 0 0
Lima
Country [272] 0 0
Poland
State/province [272] 0 0
Bialystok
Country [273] 0 0
Poland
State/province [273] 0 0
Bydgoszcz
Country [274] 0 0
Poland
State/province [274] 0 0
Bytom
Country [275] 0 0
Poland
State/province [275] 0 0
Elblag
Country [276] 0 0
Poland
State/province [276] 0 0
Elk
Country [277] 0 0
Poland
State/province [277] 0 0
Gdansk
Country [278] 0 0
Poland
State/province [278] 0 0
Jelenia Gora
Country [279] 0 0
Poland
State/province [279] 0 0
Katowice
Country [280] 0 0
Poland
State/province [280] 0 0
Klodzko
Country [281] 0 0
Poland
State/province [281] 0 0
Krakow
Country [282] 0 0
Poland
State/province [282] 0 0
Lodz
Country [283] 0 0
Poland
State/province [283] 0 0
Lomza
Country [284] 0 0
Poland
State/province [284] 0 0
Lubin
Country [285] 0 0
Poland
State/province [285] 0 0
Lublin
Country [286] 0 0
Poland
State/province [286] 0 0
Ostroleka
Country [287] 0 0
Poland
State/province [287] 0 0
Radom
Country [288] 0 0
Poland
State/province [288] 0 0
Rybnik
Country [289] 0 0
Poland
State/province [289] 0 0
Tarnów
Country [290] 0 0
Poland
State/province [290] 0 0
Torun
Country [291] 0 0
Poland
State/province [291] 0 0
Walbrzych
Country [292] 0 0
Poland
State/province [292] 0 0
Warszawa
Country [293] 0 0
Poland
State/province [293] 0 0
Wloclawek
Country [294] 0 0
Poland
State/province [294] 0 0
Wroclaw
Country [295] 0 0
Poland
State/province [295] 0 0
Zamosc
Country [296] 0 0
Portugal
State/province [296] 0 0
Almada
Country [297] 0 0
Portugal
State/province [297] 0 0
Amadora
Country [298] 0 0
Portugal
State/province [298] 0 0
Coimbra
Country [299] 0 0
Portugal
State/province [299] 0 0
Lisboa
Country [300] 0 0
Portugal
State/province [300] 0 0
Ponta Delgada
Country [301] 0 0
Portugal
State/province [301] 0 0
Setúbal
Country [302] 0 0
Portugal
State/province [302] 0 0
Évora
Country [303] 0 0
Romania
State/province [303] 0 0
Brasov
Country [304] 0 0
Romania
State/province [304] 0 0
Bucuresti
Country [305] 0 0
Romania
State/province [305] 0 0
Cluj Napoca
Country [306] 0 0
Romania
State/province [306] 0 0
Targu-Mures
Country [307] 0 0
Russian Federation
State/province [307] 0 0
Barnaul
Country [308] 0 0
Russian Federation
State/province [308] 0 0
Ekaterinburg
Country [309] 0 0
Russian Federation
State/province [309] 0 0
Kemerovo
Country [310] 0 0
Russian Federation
State/province [310] 0 0
Krasnodar
Country [311] 0 0
Russian Federation
State/province [311] 0 0
Krasnoyarsk
Country [312] 0 0
Russian Federation
State/province [312] 0 0
Moscow
Country [313] 0 0
Russian Federation
State/province [313] 0 0
Nizniy Novgorod
Country [314] 0 0
Russian Federation
State/province [314] 0 0
Novosibirsk
Country [315] 0 0
Russian Federation
State/province [315] 0 0
Saint-Peterburg
Country [316] 0 0
Russian Federation
State/province [316] 0 0
Saint-Petersburg
Country [317] 0 0
Russian Federation
State/province [317] 0 0
Samara
Country [318] 0 0
Russian Federation
State/province [318] 0 0
St-Petersburg
Country [319] 0 0
Russian Federation
State/province [319] 0 0
Tomsk
Country [320] 0 0
Russian Federation
State/province [320] 0 0
Volgograd
Country [321] 0 0
Russian Federation
State/province [321] 0 0
Yaroslavl
Country [322] 0 0
Serbia
State/province [322] 0 0
Belgrade
Country [323] 0 0
Serbia
State/province [323] 0 0
Kragujevac
Country [324] 0 0
Serbia
State/province [324] 0 0
Nis
Country [325] 0 0
Serbia
State/province [325] 0 0
Sremska Kamenica
Country [326] 0 0
Serbia
State/province [326] 0 0
Zemun
Country [327] 0 0
Singapore
State/province [327] 0 0
Singapore
Country [328] 0 0
Slovakia
State/province [328] 0 0
Banska Bystrica
Country [329] 0 0
Slovakia
State/province [329] 0 0
Martin
Country [330] 0 0
Slovakia
State/province [330] 0 0
Nitra
Country [331] 0 0
South Africa
State/province [331] 0 0
Alberton
Country [332] 0 0
South Africa
State/province [332] 0 0
Cape Town
Country [333] 0 0
South Africa
State/province [333] 0 0
Centurion
Country [334] 0 0
South Africa
State/province [334] 0 0
Kuils River
Country [335] 0 0
South Africa
State/province [335] 0 0
Pretoria
Country [336] 0 0
Spain
State/province [336] 0 0
Alcorcón
Country [337] 0 0
Spain
State/province [337] 0 0
Alicante
Country [338] 0 0
Spain
State/province [338] 0 0
Badalona
Country [339] 0 0
Spain
State/province [339] 0 0
Barcelona
Country [340] 0 0
Spain
State/province [340] 0 0
Cáceres
Country [341] 0 0
Spain
State/province [341] 0 0
Elche
Country [342] 0 0
Spain
State/province [342] 0 0
Galdakao
Country [343] 0 0
Spain
State/province [343] 0 0
Girona
Country [344] 0 0
Spain
State/province [344] 0 0
La Laguna
Country [345] 0 0
Spain
State/province [345] 0 0
Madrid
Country [346] 0 0
Spain
State/province [346] 0 0
Murcia
Country [347] 0 0
Spain
State/province [347] 0 0
Málaga
Country [348] 0 0
Spain
State/province [348] 0 0
San Juan De Alicante
Country [349] 0 0
Spain
State/province [349] 0 0
Santander
Country [350] 0 0
Spain
State/province [350] 0 0
Santiago De Compostela
Country [351] 0 0
Spain
State/province [351] 0 0
Terrassa
Country [352] 0 0
Spain
State/province [352] 0 0
Torrevieja
Country [353] 0 0
Spain
State/province [353] 0 0
Valencia
Country [354] 0 0
Switzerland
State/province [354] 0 0
Lugano
Country [355] 0 0
Switzerland
State/province [355] 0 0
Zürich
Country [356] 0 0
Taiwan
State/province [356] 0 0
Kaohsiung
Country [357] 0 0
Taiwan
State/province [357] 0 0
Linkou
Country [358] 0 0
Taiwan
State/province [358] 0 0
Taichung
Country [359] 0 0
Taiwan
State/province [359] 0 0
Taipei
Country [360] 0 0
Thailand
State/province [360] 0 0
Bangkok
Country [361] 0 0
Thailand
State/province [361] 0 0
Khon Kaen
Country [362] 0 0
Thailand
State/province [362] 0 0
Klong Luang
Country [363] 0 0
Thailand
State/province [363] 0 0
Muang
Country [364] 0 0
Thailand
State/province [364] 0 0
Rajathavee
Country [365] 0 0
Tunisia
State/province [365] 0 0
Ariana
Country [366] 0 0
Tunisia
State/province [366] 0 0
Monastir
Country [367] 0 0
Tunisia
State/province [367] 0 0
Tunis
Country [368] 0 0
Turkey
State/province [368] 0 0
Adana
Country [369] 0 0
Turkey
State/province [369] 0 0
Ankara
Country [370] 0 0
Turkey
State/province [370] 0 0
Antalya
Country [371] 0 0
Turkey
State/province [371] 0 0
Bursa
Country [372] 0 0
Turkey
State/province [372] 0 0
Edirne
Country [373] 0 0
Turkey
State/province [373] 0 0
Erzurum
Country [374] 0 0
Turkey
State/province [374] 0 0
Eskisehir
Country [375] 0 0
Turkey
State/province [375] 0 0
Gaziantep
Country [376] 0 0
Turkey
State/province [376] 0 0
Istanbul
Country [377] 0 0
Turkey
State/province [377] 0 0
Izmir
Country [378] 0 0
Turkey
State/province [378] 0 0
Kayseri
Country [379] 0 0
Turkey
State/province [379] 0 0
Kocaeli
Country [380] 0 0
Turkey
State/province [380] 0 0
Konya
Country [381] 0 0
Turkey
State/province [381] 0 0
Malatya
Country [382] 0 0
Turkey
State/province [382] 0 0
Mersin
Country [383] 0 0
Turkey
State/province [383] 0 0
Samsun
Country [384] 0 0
Turkey
State/province [384] 0 0
Sivas
Country [385] 0 0
Ukraine
State/province [385] 0 0
Cherkasy
Country [386] 0 0
Ukraine
State/province [386] 0 0
Kharkiv
Country [387] 0 0
Ukraine
State/province [387] 0 0
Lviv
Country [388] 0 0
Ukraine
State/province [388] 0 0
Zaporozhie
Country [389] 0 0
United Kingdom
State/province [389] 0 0
Bournemouth
Country [390] 0 0
United Kingdom
State/province [390] 0 0
Bradford
Country [391] 0 0
United Kingdom
State/province [391] 0 0
Craigavon
Country [392] 0 0
United Kingdom
State/province [392] 0 0
East Kilbride
Country [393] 0 0
United Kingdom
State/province [393] 0 0
Hull
Country [394] 0 0
United Kingdom
State/province [394] 0 0
Manchester
Country [395] 0 0
United Kingdom
State/province [395] 0 0
St Leonards
Country [396] 0 0
Vietnam
State/province [396] 0 0
Hanoi
Country [397] 0 0
Vietnam
State/province [397] 0 0
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/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
Other publications