AzTrials
AzTrials

Acute Coronary SyndromePhase 3TAONCT01076764

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

A Phase 3 study testing Otamixaban, UFH and Eptifibatide in people with Acute Coronary Syndrome, run by Sanofi at 607 sites in 55 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 +… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Otamixaban, UFH and Eptifibatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13,220 participants
Where
607 sitesin 55 countries
Study dates
Apr 2010to May 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) with:
  • Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization,
  • AND
  • 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,
Show all 10Show fewer
  • AND
  • 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
  • Informed consent obtained in writing.

Who cannot join

  • 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.

Trial locations and contacts

607 sites in 55 countries.

607 sites in 55 countries

United States107 sites

  • Investigational Site Number 840534

    Alexandria, Louisiana, 71301

  • Investigational Site Number 840023

    Amarillo, Texas, 79106

  • Investigational Site Number 840904

    Ames, Iowa, 50010

  • Investigational Site Number 840101

    Anaheim, California, 92801

  • Investigational Site Number 840151

    Anaheim, California, 92801

  • Investigational Site Number 840105

    Aurora, Illinois, 60506

  • Investigational Site Number 840203

    Austin, Texas, 78745

  • Investigational Site Number 840574

    Austin, Texas, 78758

  • Investigational Site Number 840213

    Beverly Hills, California, 90211

  • Investigational Site Number 840532

    Boise, Idaho, 83712

  • Investigational Site Number 840551

    Bridgeport, Connecticut, 06606

  • Investigational Site Number 840208

    Bridgeton, Missouri, 63044

  • Investigational Site Number 840518

    Brooklyn, New York, 11215

  • Investigational Site Number 840540

    Chambersburg, Pennsylvania, 17201

  • Investigational Site Number 840585

    Charlotte, North Carolina, 28204

  • Investigational Site Number 840190

    Chicago, Illinois, 60612

  • Investigational Site Number 840205

    Chicago, Illinois, 60637

  • Investigational Site Number 840060

    Dallas, Texas, 75216

  • Investigational Site Number 840578

    Dallas, Texas

  • Investigational Site Number 840517

    Dearborn, Michigan, 48123

  • Investigational Site Number 840519

    Doylestown, Pennsylvania, 18901

  • Investigational Site Number 840003

    Erie, Pennsylvania, 16502-4604

  • Investigational Site Number 840206

    Eugene, Oregon, 97401

  • Investigational Site Number 840185

    Fort Lauderdale, Florida, 33322

  • Investigational Site Number 840715

    Fort Worth, Texas, 76104

  • Investigational Site Number 840719

    Gainesville, Georgia, 30501

  • Investigational Site Number 840515

    Greenville, North Carolina, 27834

  • Investigational Site Number 840042

    Hammond, Indiana, 46320

  • Investigational Site Number 840098

    Harrisburg, Pennsylvania, 17110

  • Investigational Site Number 840521

    Harvey, Illinois, 60426

  • Investigational Site Number 840090

    Houston, Texas, 77030

  • Investigational Site Number 840207

    Houston, Texas, 77030

  • Investigational Site Number 840559

    Houston, Texas, 77096

  • Investigational Site Number 840586

    Houston, Texas, 77096

  • Investigational Site Number 840572

    Huntington Beach, California, 92648

  • Investigational Site Number 840015

    Huntsville, Alabama, 35801

  • Investigational Site Number 840209

    Independence, Missouri, 64057

  • Investigational Site Number 840554

    Indianapolis, Indiana, 46202

  • Investigational Site Number 840028

    Jacksonville, Florida, 32204

  • Investigational Site Number 840148

    Joliet, Illinois, 60435

  • Investigational Site Number 840544

    Kalamazoo, Michigan, 49007

  • Investigational Site Number 840529

    Kalispell, Montana, 59901

  • Investigational Site Number 840194

    Kansas City, Missouri, 64108

  • Investigational Site Number 840138

    Kansas City, Missouri, 64114

  • Investigational Site Number 840056

    Kansas City, Missouri, 64128

  • Investigational Site Number 840564

    Lake Charles, Louisiana, 70601

  • Investigational Site Number 840047

    Lake Mary, Florida, 32746

  • Investigational Site Number 840721

    Littleton, Colorado, 80120

  • Investigational Site Number 840201

    Long Beach, California, 90806

  • Investigational Site Number 840071

    Los Angeles, California, 90024

  • Investigational Site Number 840557

    Los Angeles, California, 90024

  • Investigational Site Number 840568

    Louisville, Kentucky, 40207

  • Investigational Site Number 840513

    Manitowoc, Wisconsin, 54220

  • Investigational Site Number 840500

    Melbourne, Florida, 32901

  • Investigational Site Number 840706

    Miami, Florida, 33133

  • Investigational Site Number 840025

    Midwest City, Oklahoma, 73110

  • Investigational Site Number 840525

    Minneapolis, Minnesota, 55404

  • Investigational Site Number 840510

    Minneapolis, Minnesota, 55433

  • Investigational Site Number 840136

    Minot, North Dakota, 58701

  • Investigational Site Number 840560

    Muncie, Indiana, 47303-3400

  • Investigational Site Number 840166

    New Haven, Connecticut, 06511

  • Investigational Site Number 840533

    New Orleans, Louisiana, 70112

  • Investigational Site Number 840539

    New York, New York, 10021

  • Investigational Site Number 840903

    Northridge, California, 91328

  • Investigational Site Number 840072

    Oak Ridge, Tennessee, 37830

  • Investigational Site Number 840009

    Ocala, Florida, 34471

  • Investigational Site Number 840146

    Ocala, Florida, 34471

  • Investigational Site Number 840049

    Oklahoma City, Oklahoma, 73112

  • Investigational Site Number 840905

    Oklahoma City, Oklahoma, 73112

  • Investigational Site Number 840193

    Oklahoma City, Oklahoma, 73135

  • Investigational Site Number 840059

    Omaha, Nebraska, 68122

  • Investigational Site Number 840727

    Omaha, Nebraska, 68122

  • Investigational Site Number 840079

    Omaha, Nebraska, 68131

  • Investigational Site Number 840577

    Orlando, Florida, 32803

  • Investigational Site Number 840912

    Overland, Kansas, 66209

  • Investigational Site Number 840573

    Philadelphia, Pennsylvania, 19104

  • Investigational Site Number 840569

    Phoenix, Arizona, 85008

  • Investigational Site Number 840703

    Phoenix, Arizona, 85054

  • Investigational Site Number 840075

    Pittsburgh, Pennsylvania, 15224

  • Investigational Site Number 840911

    Pittsburgh, Pennsylvania, 15240

  • Investigational Site Number 840566

    Raleigh, North Carolina, 27610

  • Investigational Site Number 840157

    Reno, Nevada, 89502

  • Investigational Site Number 840553

    Richmond, Virginia, 23249

  • Investigational Site Number 840188

    Richmond, Virginia, 23298

  • Investigational Site Number 840531

    Saginaw, Michigan, 48602

  • Investigational Site Number 840165

    Salem, Virginia, 24153

  • Investigational Site Number 840065

    San Francisco, California, 94143

  • Investigational Site Number 840561

    Santa Rosa, California, 95405

  • Investigational Site Number 840021

    Sarasota, Florida, 34239

  • Investigational Site Number 840210

    St Louis, Missouri, 63128

  • Investigational Site Number 840530

    St Louis, Missouri, 63128

  • Investigational Site Number 840580

    St Louis, Missouri, 63128

  • Investigational Site Number 840052

    St Louis, Missouri, 63131

  • Investigational Site Number 840902

    St. Petersburg, Florida, 33701

  • Investigational Site Number 840121

    Tacoma, Washington, 98405

  • Investigational Site Number 840508

    Tampa, Florida, 33613

  • Investigational Site Number 840082

    Toledo, Ohio, 43608

  • Investigational Site Number 840901

    Tulsa, Oklahoma, 74104

  • Investigational Site Number 840527

    Tupelo, Mississippi, 38801

  • Investigational Site Number 840087

    Tyler, Texas, 75701

  • Investigational Site Number 840910

    Victoria, Texas, 77901

  • Investigational Site Number 840211

    Washington, Pennsylvania, 15301

  • Investigational Site Number 840520

    Washington D.C., District of Columbia, 20010

  • Investigational Site Number 840058

    West Des Moines, Iowa, 50266

  • Investigational Site Number 840555

    Wichita Falls, Texas, 76310

  • Investigational Site Number 840565

    Winchester, Virginia, 22601

  • Investigational Site Number 840908

    Winston-Salem, North Carolina, 27157-1071

Other trials in United States

Argentina33 sites

  • Investigational Site Number 032048

    Adrogué, B1846DSK

  • Investigational Site Number 032013

    Avellaneda, 1870

  • Investigational Site Number 032046

    Buenos Aires, 1118

  • Investigational Site Number 032043

    Buenos Aires, C1118AAE

  • Investigational Site Number 032003

    Buenos Aires, C1181ACH

  • Investigational Site Number 032032

    Buenos Aires, C1425FSD

  • Investigational Site Number 032014

    Caba, B7400XAC

  • Investigational Site Number 032007

    Capital Federal, 1181

  • Investigational Site Number 032039

    Capital Federal, C1093AAS

  • Investigational Site Number 032045

    Capital Federal

  • Investigational Site Number 032029

    Ciudad Autonoma de Bs.As, 1428

  • Investigational Site Number 032036

    Ciudad de Buenos Aires, C1426BOR

  • Investigational Site Number 032044

    Córdoba, X5004BCL

  • Investigational Site Number 032010

    Córdoba, X5119XAA

  • Investigational Site Number 032001

    Corrientes, 3400

  • Investigational Site Number 032018

    La Plata, (B1900AXI)

  • Investigational Site Number 032027

    La Plata

  • Investigational Site Number 032020

    Mendoza, 5500

  • Investigational Site Number 032033

    Olivos, 1638

  • Investigational Site Number 032022

    Pilar, 1629

  • Investigational Site Number 032023

    Resistencia, 3500

  • Investigational Site Number 032002

    Resistencia

  • Investigational Site Number 032004

    Rosario, 2000

  • Investigational Site Number 032005

    Rosario, 2000

  • Investigational Site Number 032021

    Rosario, 2000

  • Investigational Site Number 032028

    Rosario, 2000

  • Investigational Site Number 032040

    Rosario, 2000

  • Investigational Site Number 032035

    San Juan Bautista, B1888AAE

  • Investigational Site Number 032025

    San Luis, 5700

  • Investigational Site Number 032024

    San Martin, 1650

  • Investigational Site Number 032008

    San Miguel de Tucumán, T4000NIL

  • Investigational Site Number 032041

    Santa Fe, 3000

  • Investigational Site Number 032006

    Santa Fe, S3000FWO

Other trials in Argentina

India33 sites

  • Investigational Site Number 356019

    Ahmedabad, 380014

  • Investigational Site Number 356004

    Ahmedabad, 380054

  • Investigational Site Number 356007

    Ahmedabad, 380060

  • Investigational Site Number 356012

    Allahabād, 211003

  • Investigational Site Number 356008

    Bangalore, 560054

  • Investigational Site Number 356020

    Chandigarh, 160062

  • Investigational Site Number 356029

    Gūrgaon, 122001

  • Investigational Site Number 356027

    Gūrgaon

  • Investigational Site Number 356040

    Hyderabad, 500001

  • Investigational Site Number 356046

    Hyderabad, 500055

  • Investigational Site Number 356014

    Jaipur

  • Investigational Site Number 356003

    Karamsad, 388325

  • Investigational Site Number 356037

    Kochi, 682018

  • Investigational Site Number 356034

    Kolkata, 700027

  • Investigational Site Number 356039

    Madurai, 625107

  • Investigational Site Number 356018

    Mangalore

  • Investigational Site Number 356021

    Mumbai, 400050

  • Investigational Site Number 356016

    Mumbai

  • Investigational Site Number 356031

    Mumbai

  • Investigational Site Number 356032

    Mumbai

  • Investigational Site Number 356011

    Mysore, 570020

  • Investigational Site Number 356022

    Nagpur, 440012

  • Investigational Site Number 356035

    Nagpur, 440012

  • Investigational Site Number 356023

    Nagpur

  • Investigational Site Number 356036

    Nashik, 422005

  • Investigational Site Number 356025

    New Delhi, 110 070.

  • Investigational Site Number 356001

    New Delhi, 110060

  • Investigational Site Number 356026

    New Delhi

  • Investigational Site Number 356010

    Pune, 411004

  • Investigational Site Number 356033

    Pune, 411004

  • Investigational Site Number 356024

    Secunderabad, 500 003

  • Investigational Site Number 356002

    Varanasi, 221010

  • Investigational Site Number 356044

    Vijaywada, 520002

Other trials in India

Poland29 sites

  • Investigational Site Number 616005

    Bialystok, 15-276

  • Investigational Site Number 616038

    Bialystok, 15-276

  • Investigational Site Number 616017

    Bydgoszcz, 85-168

  • Investigational Site Number 616009

    Bytom, 41-902

  • Investigational Site Number 616040

    Elblag, 82-300

  • Investigational Site Number 616027

    Ełk, 19-300

  • Investigational Site Number 616023

    Gdansk, 80-952

  • Investigational Site Number 616032

    Jelenia Góra, 58-506

  • Investigational Site Number 616037

    Katowice, 40-635

  • Investigational Site Number 616046

    Katowice, 40-635

  • Investigational Site Number 616034

    Kłodzko, 57-300

  • Investigational Site Number 616045

    Krakow, 31 -202

  • Investigational Site Number 616002

    Krakow, 31-501

  • Investigational Site Number 616029

    Lodz, 91-347

  • Investigational Site Number 616004

    Łomża, 18-400

  • Investigational Site Number 616024

    Lubin, 59-301

  • Investigational Site Number 616041

    Lublin, 20-954

  • Investigational Site Number 616016

    Ostrołęka, 07-400

  • Investigational Site Number 616003

    Radom, 26-600

  • Investigational Site Number 616047

    Radom, 26-610

  • Investigational Site Number 616033

    Rybnik, 44-200

  • Investigational Site Number 616019

    Tarnów, 33-100

  • Investigational Site Number 616022

    Torun, 87-100

  • Investigational Site Number 616018

    Wałbrzych, 58-309

  • Investigational Site Number 616014

    Warsaw, 02-507

  • Investigational Site Number 616001

    Warsaw, 04-628

  • Investigational Site Number 616031

    Włocławek, 87-800

  • Investigational Site Number 616015

    Wroclaw, 50-420

  • Investigational Site Number 616020

    Zamość, 22-400

Other trials in Poland

Italy28 sites

  • Investigational Site Number 380902

    Bergamo, 24127

  • Investigational Site Number 380918

    Bologna, 40138

  • Investigational Site Number 380904

    Brescia, 25123

  • Investigational Site Number 380928

    Brescia, 25124

  • Investigational Site Number 380929

    Castellanza, 21053

  • Investigational Site Number 380930

    Catania, 95123

  • Investigational Site Number 380912

    Catania, 95124

  • Investigational Site Number 380932

    Cittadella, 35013

  • Investigational Site Number 380926

    Conegliano, 31015

  • Investigational Site Number 380909

    Empoli, 50053

  • Investigational Site Number 380924

    Forlì, 47100

  • Investigational Site Number 380908

    Livorno, 57123

  • Investigational Site Number 380923

    Massa, 54100

  • Investigational Site Number 380935

    Massa, 54100

  • Investigational Site Number 380933

    Messina, 98100

  • Investigational Site Number 380910

    Milan, 20138

  • Investigational Site Number 380905

    Modena, 41041

  • Investigational Site Number 380936

    Naples, 88100

  • Investigational Site Number 380901

    Perugia, 06132

  • Investigational Site Number 380907

    Pescara, 65100

  • Investigational Site Number 380919

    Pordenone, 33170

  • Investigational Site Number 380916

    Reggio Emilia, 42100

  • Investigational Site Number 380931

    Roma, 00168

  • Investigational Site Number 380917

    Roma, 00189

  • Investigational Site Number 380927

    Rovigo, 45100

  • Investigational Site Number 380921

    Rozzano, 20089

  • Investigational Site Number 380914

    Seriate, 24068

  • Investigational Site Number 380925

    Treviso, 31100

Other trials in Italy

Spain24 sites

  • Investigational Site Number 724013

    Alcorcón, 28992

  • Investigational Site Number 724001

    Alicante, 03010

  • Investigational Site Number 724014

    Badalona, 08916

  • Investigational Site Number 724022

    Barcelona, 08003

  • Investigational Site Number 724021

    Barcelona, 08025

  • Investigational Site Number 724025

    Barcelona, 08035

  • Investigational Site Number 724002

    Barcelona, 08036

  • Investigational Site Number 724901

    Barcelona, 08907

  • Investigational Site Number 724007

    Cáceres, 10003

  • Investigational Site Number 724026

    Elche, 03293

  • Investigational Site Number 724016

    Galdakao, 48960

  • Investigational Site Number 724023

    Girona, 17007

  • Investigational Site Number 724003

    Madrid, 28035

  • Investigational Site Number 724902

    Madrid, 28040

  • Investigational Site Number 724027

    Madrid, 28041

  • Investigational Site Number 724017

    Málaga, 29010

  • Investigational Site Number 724904

    Murcia, 30120

  • Investigational Site Number 724006

    San Cristóbal de La Laguna, 38320

  • Investigational Site Number 724018

    Sant Joan d'Alacant, 03550

  • Investigational Site Number 724005

    Santander, 39008

  • Investigational Site Number 724012

    Santiago de Compostela, 15706

  • Investigational Site Number 724903

    Terrassa, 08221

  • Investigational Site Number 724010

    Torrevieja

  • Investigational Site Number 724024

    Valencia, 46010

Other trials in Spain

Turkey (Türkiye)24 sites

  • Investigational Site Number 792010

    Adana, 01339

  • Investigational Site Number 792023

    Ankara, 06100

  • Investigational Site Number 792009

    Antalya, 07059

  • Investigational Site Number 792008

    Bursa, 16100

  • Investigational Site Number 792022

    Bursa, 16509

  • Investigational Site Number 792030

    Edirne, 22030

  • Investigational Site Number 792006

    Erzurum, 25070

  • Investigational Site Number 792020

    Eskişehir, 26480

  • Investigational Site Number 792004

    Gaziantep, 27060

  • Investigational Site Number 792018

    Istanbul, 34034

  • Investigational Site Number 792032

    Istanbul, 34093

  • Investigational Site Number 792028

    Istanbul, 34390

  • Investigational Site Number 792016

    Istanbul, 34846

  • Investigational Site Number 792029

    Istanbul

  • Investigational Site Number 792011

    Izmir, 35100

  • Investigational Site Number 792001

    Izmir, 35340

  • Investigational Site Number 792003

    Izmir, 35360

  • Investigational Site Number 792012

    Kayseri, 38039

  • Investigational Site Number 792014

    Kocaeli, 41300

  • Investigational Site Number 792015

    Konya, 42080

  • Investigational Site Number 792025

    Malatya

  • Investigational Site Number 792019

    Mersin, 33169

  • Investigational Site Number 792021

    Samsun, 55200

  • Investigational Site Number 792026

    Sivas, 58140

Other trials in Turkey (Türkiye)

Russia21 sites

  • Investigational Site Number 643018

    Barnaul, 656055

  • Investigational Site Number 643011

    Kemerovo, 650002

  • Investigational Site Number 643014

    Krasnodar, 350086

  • Investigational Site Number 643021

    Krasnoyarsk, 660022

  • Investigational Site Number 643005

    Moscow, 105229

  • Investigational Site Number 643004

    Moscow, 111539

  • Investigational Site Number 643020

    Moscow, 115446

  • Investigational Site Number 643003

    Moscow, 121359

  • Investigational Site Number 643001

    Moscow, 121552

  • Investigational Site Number 643016

    Nizniy Novgorod, 603005

  • Investigational Site Number 643024

    Novosibirsk, 630055

  • Investigational Site Number 643006

    Saint Petersburg, 192242

  • Investigational Site Number 643019

    Saint Petersburg, 194156

  • Investigational Site Number 643025

    Saint Petersburg, 195067

  • Investigational Site Number 643007

    Saint Petersburg, 197341

  • Investigational Site Number 643008

    Saint-Peterburg, 196105

  • Investigational Site Number 643013

    Samara, 443070

  • Investigational Site Number 643012

    Tomsk, 634012

  • Investigational Site Number 643023

    Volgograd, 400008

  • Investigational Site Number 643017

    Yaroslavl, 150062

  • Investigational Site Number 643015

    Yekaterinburg, 620109

Other trials in Russia

Brazil20 sites

  • Investigational Site Number 076025

    Campinas, 13015-001

  • Investigational Site Number 076011

    Fortaleza, 60864190

  • Investigational Site Number 076015

    Marília, 17515-460

  • Investigational Site Number 076016

    Maringá, 87015-290

  • Investigational Site Number 076013

    Passo Fundo, 99010-080

  • Investigational Site Number 076009

    Porto Alegre, 90035-001

  • Investigational Site Number 076001

    Porto Alegre, 90610-000

  • Investigational Site Number 076022

    Porto Alegre, 90620-001

  • Investigational Site Number 076004

    Porto Alegre, 91350-250

  • Investigational Site Number 076023

    Recife, 50100-060

  • Investigational Site Number 076030

    Recife, 52051-380

  • Investigational Site Number 076027

    Rio de Janeiro, 20221903

  • Investigational Site Number 076029

    Salvador, 41148-900

  • Investigational Site Number 076014

    São José do Rio Preto, 15015-210

  • Investigational Site Number 076002

    São José do Rio Preto, 15090-000

  • Investigational Site Number 076012

    São Paulo, 01323-001

  • Investigational Site Number 076020

    São Paulo, 04012-180

  • Investigational Site Number 076007

    São Paulo, 05403-000

  • Investigational Site Number 076008

    Uberlândia, 38400-368

  • Investigational Site Number 076024

    Votuporanga, 15500-003

Other trials in Brazil

South Korea18 sites

  • Investigational Site Number 410005

    Busan, 602-715

  • Investigational Site Number 410006

    Busan, 614-735

  • Investigational Site Number 410002

    Daegu, 700-712

  • Investigational Site Number 410014

    Daegu, 705-717

  • Investigational Site Number 410017

    Daejeon

  • Investigational Site Number 410004

    Goyang, 410-773

  • Investigational Site Number 410018

    Guri-si, 471-020

  • Investigational Site Number 410016

    Gwangju, 501-757

  • Investigational Site Number 410007

    Seongnam, 463-707

  • Investigational Site Number 410008

    Seoul, 110-744

  • Investigational Site Number 410012

    Seoul, 120-752

  • Investigational Site Number 410011

    Seoul, 130-709

  • Investigational Site Number 410001

    Seoul, 134-727

  • Investigational Site Number 410009

    Seoul, 137-701

  • Investigational Site Number 410010

    Seoul, 138-736

  • Investigational Site Number 410003

    Seoul, 152-703

  • Investigational Site Number 410013

    Suwon, 443-721

  • Investigational Site Number 410015

    Wŏnju, 220-701

Other trials in South Korea

Chile17 sites

  • Investigational Site Number 152003

    Antofagasta

  • Investigational Site Number 152906

    Concepción, 4070038

  • Investigational Site Number 152005

    Iquique

  • Investigational Site Number 152004

    Santiago, 751-0009

  • Investigational Site Number 152001

    Santiago, 756-0171

  • Investigational Site Number 152902

    Santiago, 820-7257

  • Investigational Site Number 152901

    Santiago, 8380456

  • Investigational Site Number 152903

    Santiago, 890-0085

  • Investigational Site Number 152010

    Santiago

  • Investigational Site Number 152012

    Santiago

  • Investigational Site Number 152011

    Talcahuano, 427-0918

  • Investigational Site Number 152908

    Temuco

  • Investigational Site Number 152913

    Temuco

  • Investigational Site Number 152016

    Valdivia

  • Investigational Site Number 152912

    Valparaíso, 234-0207

  • Investigational Site Number 152907

    Viña del Mar

  • Investigational Site Number 152910

    Viña del Mar

Other trials in Chile

Germany16 sites

  • Investigational Site Number 276022

    Berlin, 12559

  • Investigational Site Number 276004

    Berlin, 13347

  • Investigational Site Number 276024

    Berlin, 13353

  • Investigational Site Number 276023

    Bonn, 53115

  • Investigational Site Number 276006

    Frankfurt am Main, 65929

  • Investigational Site Number 276901

    Freiburg im Breisgau, 79106

  • Investigational Site Number 276003

    Hamburg, 22041

  • Investigational Site Number 276902

    Hamburg, 22527

  • Investigational Site Number 276009

    Heidelberg, 69120

  • Investigational Site Number 276904

    Heidenheim, 89522

  • Investigational Site Number 276002

    Kassel, 34121

  • Investigational Site Number 276013

    Langen, 63225

  • Investigational Site Number 276001

    Mainz, 55131

  • Investigational Site Number 276905

    Mönchengladbach, 41063

  • Investigational Site Number 276005

    München, 81377

  • Investigational Site Number 276018

    Rostock, 18057

Other trials in Germany

France15 sites

  • Investigational Site Number 250016

    Avignon, 84082

  • Investigational Site Number 250010

    Bayonne, 64100

  • Investigational Site Number 250002

    Belfort, 90016

  • Investigational Site Number 250001

    Besançon, 25030

  • Investigational Site Number 250006

    Créteil, 94010

  • Investigational Site Number 250003

    Dijon, 21034

  • Investigational Site Number 250013

    Le Chesnay, 78187

  • Investigational Site Number 250012

    Montfermeil, 93370

  • Investigational Site Number 250005

    Mulhouse, 68067

  • Investigational Site Number 250015

    Mulhouse, 68070

  • Investigational Site Number 250009

    Paris, 75018

  • Investigational Site Number 250011

    Pau, 64046

  • Investigational Site Number 250007

    Rouen, 76031

  • Investigational Site Number 250014

    Strasbourg, 67091

  • Investigational Site Number 250008

    Toulouse, 31059

Other trials in France

Mexico15 sites

  • Investigational Site Number 484009

    Aguascalientes, 20230

  • Investigational Site Number 484907

    Aguascalientes, 20230

  • Investigational Site Number 484902

    Guadalajara, 44100

  • Investigational Site Number 484015

    Guadalajara, 44670

  • Investigational Site Number 484901

    Guadalajara, CP 64630

  • Investigational Site Number 484019

    Mérida, 97000

  • Investigational Site Number 484003

    Mexico City, 14000

  • Investigational Site Number 484914

    México Df, 14080

  • Investigational Site Number 484004

    Monterrey, 64460

  • Investigational Site Number 484910

    Morelia, Michoacan, 58070

  • Investigational Site Number 484020

    Puebla City, 72460

  • Investigational Site Number 484017

    Querétaro, 76000

  • Investigational Site Number 484012

    San Luis Potosí City, 72244

  • Investigational Site Number 484911

    San Luis Potosí City, 78200

  • Investigational Site Number 484013

    Xalapa, 91020

Other trials in Mexico

Bulgaria12 sites

  • Investigational Site Number 100511

    Blagoevgrad, 2700

  • Investigational Site Number 100508

    Kazanlak, 6100

  • Investigational Site Number 100512

    Pazardzhik, 4400

  • Investigational Site Number 100505

    Pleven, 5800

  • Investigational Site Number 100509

    Rousse

  • Investigational Site Number 100510

    Sandanski, 2800

  • Investigational Site Number 100501

    Sofia, 1202

  • Investigational Site Number 100502

    Sofia, 1407

  • Investigational Site Number 100503

    Sofia, 1431

  • Investigational Site Number 100507

    Varna, 9000

  • Investigational Site Number 100504

    Veliko Tarnovo, 5000

  • Investigational Site Number 100506

    Yambol, 8600

Other trials in Bulgaria

Israel12 sites

  • Investigational Site Number 376005

    Afula, 18101

  • Investigational Site Number 376003

    Ashkelon, 78278

  • Investigational Site Number 376011

    Hadera, 38100

  • Investigational Site Number 376004

    Haifa, 31048

  • Investigational Site Number 376009

    Haifa, 31096

  • Investigational Site Number 376010

    Holon, 58100

  • Investigational Site Number 376002

    Jerusalem, 91031

  • Investigational Site Number 376013

    Jerusalem, 91120

  • Investigational Site Number 376007

    Safed, 13100

  • Investigational Site Number 376008

    Tel Aviv, 64239

  • Investigational Site Number 376001

    Tel HaShomer, 52621

  • Investigational Site Number 376012

    Tzrifin, 70300

Other trials in Israel

Czechia11 sites

  • Investigational Site Number 203005

    Brno, 62500

  • Investigational Site Number 203903

    Hradec Králové, 50005

  • Investigational Site Number 203902

    Liberec, 46063

  • Investigational Site Number 203009

    Olomouc, 77520

  • Investigational Site Number 203010

    Ostrava - Poruba, 70852

  • Investigational Site Number 203001

    Prague, 10034

  • Investigational Site Number 203901

    Prague, 12808

  • Investigational Site Number 203007

    Prague, 15006

  • Investigational Site Number 203003

    Prague, 15030

  • Investigational Site Number 203002

    Ústí nad Labem, 40113

  • Investigational Site Number 203006

    Zlín, 76275

Other trials in Czechia

Greece11 sites

  • Investigational Site Number 300009

    Alexandroupoli, 68100

  • Investigational Site Number 300004

    Athens, 10676

  • Investigational Site Number 300001

    Athens, 11527

  • Investigational Site Number 300011

    Athens, 11528

  • Investigational Site Number 300007

    Chios, 82100

  • Investigational Site Number 300008

    Larissa, 41110

  • Investigational Site Number 300003

    Melíssia, 151 27

  • Investigational Site Number 300005

    N. Ionia, 14233

  • Investigational Site Number 300002

    Pátrai, 26500

  • Investigational Site Number 300010

    Thessaloniki, 546 36

  • Investigational Site Number 300006

    Thessaloniki, 57010

Other trials in Greece

Hungary9 sites

  • Investigational Site Number 348003

    Budapest, 1027

  • Investigational Site Number 348008

    Budapest, 1096

  • Investigational Site Number 348002

    Budapest, 1122

  • Investigational Site Number 348004

    Budapest, 1134

  • Investigational Site Number 348009

    Szeged, 6720

  • Investigational Site Number 348007

    Székesfehérvár, 8000

  • Investigational Site Number 348001

    Szolnok, 5000

  • Investigational Site Number 348005

    Szombathely, 9700

  • Investigational Site Number 348006

    Zalaegerszeg, 8900

Other trials in Hungary

Peru9 sites

  • Investigational Site Number 604005

    Lambayeque

  • Investigational Site Number 604002

    Lima, 051

  • Investigational Site Number 604011

    Lima, 051

  • Investigational Site Number 604014

    Lima, LIMA 01

  • Investigational Site Number 604003

    Lima, LIMA 11

  • Investigational Site Number 604017

    Lima, LIMA 13

  • Investigational Site Number 604006

    Lima, LIMA 27

  • Investigational Site Number 604012

    Lima, LIMA 31

  • Investigational Site Number 604008

    Lima

Other trials in Peru

Colombia8 sites

  • Investigational Site Number 170016

    Barranquilla

  • Investigational Site Number 170009

    Bogotá

  • Investigational Site Number 170011

    Bogotá

  • Investigational Site Number 170002

    Bucaramanga

  • Investigational Site Number 170012

    Cali

  • Investigational Site Number 170001

    Medellín

  • Investigational Site Number 170003

    Medellín

  • Investigational Site Number 170017

    Medellín

Other trials in Colombia

Portugal8 sites

  • Investigational Site Number 620010

    Almada, 2801-951

  • Investigational Site Number 620006

    Amadora, 2720

  • Investigational Site Number 620001

    Coimbra, 3000-075

  • Investigational Site Number 620002

    Coimbra, 3041-801

  • Investigational Site Number 620011

    Evora, 7000

  • Investigational Site Number 620003

    Lisbon, 1169-024

  • Investigational Site Number 620015

    Ponta Delgada, 9500-370

  • Investigational Site Number 620004

    Setúbal, 2910-446

Other trials in Portugal

Australia7 sites

  • Investigational Site Number 036008

    Adelaide, 5000

  • Investigational Site Number 036004

    Ballarat, 3353

  • Investigational Site Number 036010

    Concord, 2137

  • Investigational Site Number 036001

    Herston, 4029

  • Investigational Site Number 036913

    Hobart, 7001

  • Investigational Site Number 036011

    Liverpool, 2170

  • Investigational Site Number 036003

    Prahran, 3004

Other trials in Australia

Canada7 sites

  • Investigational Site Number 124005

    Gatineau, J8Y 1W7

  • Investigational Site Number 124006

    Hamilton, L8L 2X2

  • Investigational Site Number 124004

    Montreal, H2W 1T8

  • Investigational Site Number 124001

    Québec, G1V 4G5

  • Investigational Site Number 124007

    Sherbrooke, J1H 5N4

  • Investigational Site Number 124009

    St. John's, E2L 4L2

  • Investigational Site Number 124002

    Toronto, M5B 1W8

Other trials in Canada

Taiwan7 sites

  • Investigational Site Number 158007

    Kaohsiung City, 807

  • Investigational Site Number 158002

    Kaohsiung City, 833

  • Investigational Site Number 158003

    Linkou District

  • Investigational Site Number 158008

    Taichung, 40447

  • Investigational Site Number 158904

    Taipei, 100

  • Investigational Site Number 158001

    Taipei, 104

  • Investigational Site Number 158009

    Taipei, 220

Other trials in Taiwan

Thailand7 sites

  • Investigational Site Number 764002

    Bangkok, 10330

  • Investigational Site Number 764901

    Bangkok, 10400

  • Investigational Site Number 764005

    Bangkok, 10700

  • Investigational Site Number 764004

    Khon Kaen, 40002

  • Investigational Site Number 764007

    Klong Luang, 12120

  • Investigational Site Number 764903

    Muang, 50200

  • Investigational Site Number 764006

    Rajathavee, 10400

Other trials in Thailand

United Kingdom7 sites

  • Investigational Site Number 826008

    Bournemouth, BH7 7DW

  • Investigational Site Number 826007

    Bradford, BD9 6RJ

  • Investigational Site Number 826001

    Craigavon, BT63 5QQ

  • Investigational Site Number 826005

    East Kilbride, G75 8RG

  • Investigational Site Number 826002

    Hull, HU16 5JQ

  • Investigational Site Number 826006

    Manchester, M13 9WL

  • Investigational Site Number 826003

    St Leonards, TN37 7RD

Other trials in United Kingdom

Serbia6 sites

  • Investigational Site Number 688505

    Belgrade, 11040

  • Investigational Site Number 688502

    Kamenitz, 21204

  • Investigational Site Number 688501

    Kragujevac, 34000

  • Investigational Site Number 688503

    Niš, 18000

  • Investigational Site Number 688504

    Zemun, 11080

  • Investigational Site Number 688506

    Zemun, 11080

Other trials in Serbia

South Africa6 sites

  • Investigational Site Number 710004

    Alberton, 1450

  • Investigational Site Number 710005

    Cape Town, 7500

  • Investigational Site Number 710001

    Cape Town, 7925

  • Investigational Site Number 710003

    Centurion, 181

  • Investigational Site Number 710002

    Kuils River, 7580

  • Investigational Site Number 710007

    Pretoria

Other trials in South Africa

Belgium5 sites

  • Investigational Site Number 056001

    Bonheiden, 2820

  • Investigational Site Number 056007

    Bruges, 8000

  • Investigational Site Number 056003

    Brussels, 1020

  • Investigational Site Number 056006

    Haine-Saint-Paul, 7100

  • Investigational Site Number 056008

    Leuven, 3000

Other trials in Belgium

Indonesia5 sites

  • Investigational Site Number 360505

    Bandung, 40161

  • Investigational Site Number 360501

    Depok, 16514

  • Investigational Site Number 360506

    Jakarta, 10430

  • Investigational Site Number 360503

    Jakarta, 11420

  • Investigational Site Number 360502

    Jakarta, 12950

Other trials in Indonesia

Netherlands5 sites

  • Investigational Site Number 528003

    Alkmaar, 1815 JD

  • Investigational Site Number 528005

    Arnhem, 6815 AD

  • Investigational Site Number 528007

    Leeuwarden, 8934 AD

  • Investigational Site Number 528004

    Nieuwegein, 3435 CM

  • Investigational Site Number 528002

    Rotterdam, 3079 DZ

Other trials in Netherlands

Romania5 sites

  • Investigational Site Number 642002

    Brasov, 500059

  • Investigational Site Number 642004

    Bucharest, 011461

  • Investigational Site Number 642001

    Bucharest, 014461

  • Investigational Site Number 642005

    Cluj-Napoca, 400001

  • Investigational Site Number 642003

    Târgu Mureş, 20475

Other trials in Romania

Tunisia5 sites

  • Investigational Site Number 788002

    Aryanah, 2080

  • Investigational Site Number 788005

    Monastir, 5000

  • Investigational Site Number 788006

    Monastir, 5000

  • Investigational Site Number 788001

    Tunis, 1008

  • Investigational Site Number 788004

    Tunis, 1008

Other trials in Tunisia

Vietnam5 sites

  • Investigational Site Number 704006

    Hanoi

  • Investigational Site Number 704001

    Ho Chi Minh City

  • Investigational Site Number 704003

    Ho Chi Minh City

  • Investigational Site Number 704004

    Ho Chi Minh City

  • Investigational Site Number 704005

    Ho Chi Minh City

Other trials in Vietnam

Belarus4 sites

  • Investigational Site Number 112004

    Homyel, 246012

  • Investigational Site Number 112003

    Minsk, 220013

  • Investigational Site Number 112002

    Minsk, 220016

  • Investigational Site Number 112001

    Minsk, 220036

Other trials in Belarus

Croatia4 sites

  • Investigational Site Number 191502

    Slavonski Brod, 35000

  • Investigational Site Number 191503

    Zagreb, 10000

  • Investigational Site Number 191505

    Zagreb, 10000

  • Investigational Site Number 191506

    Zagreb, 10000

Other trials in Croatia

Egypt4 sites

  • Investigational Site Number 818504

    Cairo, 11451

  • Investigational Site Number 818501

    Cairo, 11566

  • Investigational Site Number 818502

    Cairo

  • Investigational Site Number 818503

    Giza

Other trials in Egypt

Latvia4 sites

  • Investigational Site Number 428004

    Daugavpils, LV-5417

  • Investigational Site Number 428002

    Liepāja, LV-3414

  • Investigational Site Number 428001

    Riga, LV-1002

  • Investigational Site Number 428003

    Riga, LV-1038

Other trials in Latvia

Ukraine4 sites

  • Investigational Site Number 804004

    Cherkasy, 18000

  • Investigational Site Number 804001

    Kharkiv, 61018

  • Investigational Site Number 804005

    Lviv, 79015

  • Investigational Site Number 804003

    Zaporozhie, 69600

Other trials in Ukraine

Lithuania3 sites

  • Investigational Site Number 440003

    Kaunas, LT-50009

  • Investigational Site Number 440001

    Šiauliai, LT-76231

  • Investigational Site Number 440904

    Vilnius, LT-08661

Other trials in Lithuania

New Zealand3 sites

  • Investigational Site Number 554004

    Auckland

  • Investigational Site Number 554001

    Hamilton, 3200

  • Investigational Site Number 554002

    Nelson, 7040

Other trials in New Zealand

Norway3 sites

  • Investigational Site Number 578903

    Arendal, 4809

  • Investigational Site Number 578901

    Bergen, 5021

  • Investigational Site Number 578902

    Stavanger, 4011

Other trials in Norway

Slovakia3 sites

  • Investigational Site Number 703003

    Banská Bystrica, 97401

  • Investigational Site Number 703002

    Martin, 03659

  • Investigational Site Number 703001

    Nitra, 950 01

Other trials in Slovakia

Austria2 sites

  • Investigational Site Number 040002

    Vienna, 1090

  • Investigational Site Number 040001

    Vienna, 1160

Other trials in Austria

Estonia2 sites

  • Investigational Site Number 233001

    Tallinn, 10138

  • Investigational Site Number 233901

    Tallinn, 13419

Other trials in Estonia

Jordan2 sites

  • Investigational Site Number 400501

    Amman, 520248

  • Investigational Site Number 400502

    Irbid, 360001

Other trials in Jordan

Lebanon2 sites

  • Investigational Site Number 422502

    Beirut, Beirut

  • Investigational Site Number 422505

    Beirut

Other trials in Lebanon

Panama2 sites

  • Investigational Site Number 591502

    Panama City

  • Investigational Site Number 591504

    Panama City

Other trials in Panama

Singapore2 sites

  • Investigational Site Number 702001

    Singapore, 168752

  • Investigational Site Number 702002

    Singapore, 529889

Other trials in Singapore

Switzerland2 sites

  • Investigational Site Number 756001

    Lugano, 6900

  • Investigational Site Number 756002

    Zurich, 8091

Other trials in Switzerland

Hong Kong1 site

  • Investigational Site Number 344001

    Chai Wan

Other trials in Hong Kong

Malaysia1 site

  • Investigational Site Number 458001

    Kuching, 93586

Other trials in Malaysia

Montenegro1 site

  • Investigational Site Number 499501

    Podgorica

Other trials in Montenegro

North Macedonia1 site

  • Investigational Site Number 807501

    Skopje, 1109

Other trials in North Macedonia

About this study

Official 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

Primary Objective:

  • To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide
Read more

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
Read the 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.

Being tested
Otamixaban, Placebo (for Otamixaban), UFH, Placebo (for UFH), Eptifibatide
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OtamixabanDrug

    Also called XRP0673

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

  • Placebo (for Otamixaban)Drug

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

  • UFHDrug

    Also called Unfractionated Heparin

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

  • Placebo (for UFH)Drug

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

  • EptifibatideDrug

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

  • Placebo (for Eptifibatide)Drug

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

Study groups in NCT01076764
Study groupRoleWhat they receive
Otamixaban - 0.080 mg/kg bolus + 0.100 mg/kg/h infusionExperimentalFrom 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)
Receives: Drug: Otamixaban; Drug: Placebo (for UFH); Drug: Placebo (for Eptifibatide)
Otamixaban - 0.080 mg/kg bolus + 0.140 mg/kg/h infusionExperimentalFrom 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)
Receives: Drug: Otamixaban; Drug: Placebo (for UFH); Drug: Placebo (for Eptifibatide)
UFH + EptifibatideActive comparatorFrom 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)
Receives: Drug: Placebo (for Otamixaban); Drug: UFH; Drug: Eptifibatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction

    Measured: from randomization (day 1) to day 7

  2. Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)

    Measured: from day 1 to day 7

Secondary outcomes (4)

  1. Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke

    Measured: from day 1 to day 7

  2. Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction

    Measured: from day 1 to day 30

  3. Adjudicated all-cause death

    Measured: from day 1 to day 30

  4. Adjudicated Procedural thrombotic complications during the index PCI

    Measured: during index PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
13,220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01076764
Sponsor's protocol ID
EFC6204
Other IDs
2009-016568-36, 2009
Acronym
TAO
Status last verified
Apr 2016
First submitted
25 Feb 2010
Last updated
4 May 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 23194481

  • Steg PG, Mehta SR, Pollack CV Jr, Bode C, Cohen M, French WJ, Hoekstra J, Rao SV, Ruzyllo W, Ruiz-Nodar JM, Sabate M, Widimsky P, Kiss RG, Navarro Estrada JL, Hod H, Kerkar P, Guneri S, Sezer M, Ruda M, Nicolau JC, Cavallini C, Ebrahim I, Petrov I, Kim JH, Jeong MH, Ramos Lopez GA, Laanmets P, Kovar F, Gaudin C, Fanouillere KC, Minini P, Hoffman EB, Moryusef A, Wiviott SD, Sabatine MS; TAO Investigators. Anticoagulation with otamixaban and ischemic events in non-ST-segment elevation acute coronary syndromes: the TAO randomized clinical trial. JAMA. 2013 Sep 18;310(11):1145-55. doi: 10.1001/jama.2013.277165.

    PubMed 23995608

  • Abtan J, Wiviott SD, Sorbets E, Popovic B, Elbez Y, Mehta SR, Sabatine MS, Bode C, Pollack CV, Cohen M, Moccetti T, Laanmets P, Faxon D, Okreglicki A, Ducrocq G, Steg PG; TAO investigators. Prevalence, clinical determinants and prognostic implications of coronary procedural complications of percutaneous coronary intervention in non-ST-segment elevation myocardial infarction: Insights from the contemporary multinational TAO trial. Arch Cardiovasc Dis. 2021 Mar;114(3):187-196. doi: 10.1016/j.acvd.2020.09.005. Epub 2021 Jan 29.

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  • Dillinger JG, Ducrocq G, Elbez Y, Cohen M, Bode C, Pollack C Jr, Petrauskiene B, Henry P, Dorobantu M, French WJ, Wiviott SD, Sabatine MS, Mehta SR, Steg PG. Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Insights From the TAO Trial. Circ Cardiovasc Interv. 2021 Jan;14(1):e009759. doi: 10.1161/CIRCINTERVENTIONS.120.009759. Epub 2021 Jan 12.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Otamixaban, UFH and Eptifibatide in people with Acute Coronary Syndrome, run by Sanofi at 607 sites in 55 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 607 sites in United States, Argentina, India, Poland, Italy and 50 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction (time frame: from randomization (day 1) to day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01076764, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.

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