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

Acute Coronary Syndrome Clinical Trial

— TAO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076764
• Other study ID #: EFC6204
• Secondary ID: 2009-016568-36
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2010
• Last updated: May 16, 2013
• Start date: April 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 + 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13220
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Patient with non ST-segment elevation Acute Coronary Syndrome 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.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Myocardial Infarction

Intervention

Drug:
• Otamixaban (XRP0673)
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
• Otamixaban matching placebo
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
• Unfractionated Heparin
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
• Unfractionated Heparin matching placebo
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
• Eptifibatide
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion
• Eptifibatide matching placebo
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

Locations

Country	Name	City	State
Argentina	Investigational Site Number 032048	Adrogue
Argentina	Investigational Site Number 032013	Avellaneda
Argentina	Investigational Site Number 032003	Buenos Aires
Argentina	Investigational Site Number 032032	Buenos Aires
Argentina	Investigational Site Number 032043	Buenos Aires
Argentina	Investigational Site Number 032046	Buenos Aires
Argentina	Investigational Site Number 032014	Caba
Argentina	Investigational Site Number 032007	Capital Federal
Argentina	Investigational Site Number 032039	Capital Federal
Argentina	Investigational Site Number 032045	Capital Federal
Argentina	Investigational Site Number 032029	Ciudad Autonoma De Bs.As
Argentina	Investigational Site Number 032036	Ciudad De Buenos Aires
Argentina	Investigational Site Number 032010	Cordoba
Argentina	Investigational Site Number 032044	Cordoba
Argentina	Investigational Site Number 032001	Corrientes
Argentina	Investigational Site Number 032035	Florencio Varela
Argentina	Investigational Site Number 032018	La Plata
Argentina	Investigational Site Number 032027	La Plata
Argentina	Investigational Site Number 032020	Mendoza
Argentina	Investigational Site Number 032033	Olivos
Argentina	Investigational Site Number 032022	Pilar
Argentina	Investigational Site Number 032002	Resistencia
Argentina	Investigational Site Number 032023	Resistencia
Argentina	Investigational Site Number 032004	Rosario
Argentina	Investigational Site Number 032005	Rosario
Argentina	Investigational Site Number 032021	Rosario
Argentina	Investigational Site Number 032028	Rosario
Argentina	Investigational Site Number 032040	Rosario
Argentina	Investigational Site Number 032025	San Luis
Argentina	Investigational Site Number 032024	San Martin
Argentina	Investigational Site Number 032008	San Miguel De Tucuman
Argentina	Investigational Site Number 032006	Santa Fe
Argentina	Investigational Site Number 032041	Santa Fe
Australia	Investigational Site Number 036008	Adelaide
Australia	Investigational Site Number 036004	Ballarat
Australia	Investigational Site Number 036010	Concord
Australia	Investigational Site Number 036001	Herston
Australia	Investigational Site Number 036913	Hobart
Australia	Investigational Site Number 036011	Liverpool
Australia	Investigational Site Number 036003	Prahran
Austria	Investigational Site Number 040001	Wien
Austria	Investigational Site Number 040002	Wien
Belarus	Investigational Site Number 112004	Gomel
Belarus	Investigational Site Number 112001	Minsk
Belarus	Investigational Site Number 112002	Minsk
Belarus	Investigational Site Number 112003	Minsk
Belgium	Investigational Site Number 056001	Bonheiden
Belgium	Investigational Site Number 056007	Brugge
Belgium	Investigational Site Number 056003	Brussels
Belgium	Investigational Site Number 056006	Haine-Saint-Paul
Belgium	Investigational Site Number 056008	Leuven
Brazil	Investigational Site Number 076025	Campinas
Brazil	Investigational Site Number 076011	Fortaleza
Brazil	Investigational Site Number 076015	Marilia
Brazil	Investigational Site Number 076016	Maringa
Brazil	Investigational Site Number 076013	Passo Fundo
Brazil	Investigational Site Number 076001	Porto Alegre
Brazil	Investigational Site Number 076004	Porto Alegre
Brazil	Investigational Site Number 076009	Porto Alegre
Brazil	Investigational Site Number 076022	Porto Alegre
Brazil	Investigational Site Number 076023	Recife
Brazil	Investigational Site Number 076030	Recife
Brazil	Investigational Site Number 076027	Rio De Janeiro
Brazil	Investigational Site Number 076029	Salvador
Brazil	Investigational Site Number 076002	Sao Jose Do Rio Preto
Brazil	Investigational Site Number 076014	Sao Jose Do Rio Preto
Brazil	Investigational Site Number 076007	Sao Paulo
Brazil	Investigational Site Number 076012	Sao Paulo
Brazil	Investigational Site Number 076020	Sao Paulo
Brazil	Investigational Site Number 076008	Uberlandia
Brazil	Investigational Site Number 076024	Votuporanga
Bulgaria	Investigational Site Number 100511	Blagoevgrad
Bulgaria	Investigational Site Number 100508	Kazanlak
Bulgaria	Investigational Site Number 100512	Pazardjik
Bulgaria	Investigational Site Number 100505	Pleven
Bulgaria	Investigational Site Number 100509	Ruse
Bulgaria	Investigational Site Number 100510	Sandanski
Bulgaria	Investigational Site Number 100501	Sofia
Bulgaria	Investigational Site Number 100502	Sofia
Bulgaria	Investigational Site Number 100503	Sofia
Bulgaria	Investigational Site Number 100507	Varna
Bulgaria	Investigational Site Number 100504	Veliko Tarnovo
Bulgaria	Investigational Site Number 100506	Yambol
Canada	Investigational Site Number 124005	Gatineau
Canada	Investigational Site Number 124006	Hamilton
Canada	Investigational Site Number 124004	Montreal
Canada	Investigational Site Number 124001	Quebec
Canada	Investigational Site Number 124007	Sherbrooke
Canada	Investigational Site Number 124009	St. John
Canada	Investigational Site Number 124002	Toronto
Chile	Investigational Site Number 152003	Antofagasta
Chile	Investigational Site Number 152906	Concepcion
Chile	Investigational Site Number 152005	Iquique
Chile	Investigational Site Number 152001	Santiago
Chile	Investigational Site Number 152004	Santiago
Chile	Investigational Site Number 152010	Santiago
Chile	Investigational Site Number 152012	Santiago
Chile	Investigational Site Number 152901	Santiago
Chile	Investigational Site Number 152902	Santiago
Chile	Investigational Site Number 152903	Santiago
Chile	Investigational Site Number 152011	Talcahuano
Chile	Investigational Site Number 152908	Temuco
Chile	Investigational Site Number 152913	Temuco
Chile	Investigational Site Number 152016	Valdivia
Chile	Investigational Site Number 152912	Valparaíso
Chile	Investigational Site Number 152907	Vina Del Mar
Chile	Investigational Site Number 152910	Viña Del Mar
Colombia	Investigational Site Number 170016	Barranquilla
Colombia	Investigational Site Number 170009	Bogota
Colombia	Investigational Site Number 170011	Bogotá
Colombia	Investigational Site Number 170002	Bucaramanga
Colombia	Investigational Site Number 170012	Cali
Colombia	Investigational Site Number 170001	Medellin
Colombia	Investigational Site Number 170003	Medellin
Colombia	Investigational Site Number 170017	Medellin
Croatia	Investigational Site Number 191502	Slavonski Brod
Croatia	Investigational Site Number 191503	Zagreb
Croatia	Investigational Site Number 191505	Zagreb
Croatia	Investigational Site Number 191506	Zagreb
Czech Republic	Investigational Site Number 203005	Brno
Czech Republic	Investigational Site Number 203903	Hradec Kralove
Czech Republic	Investigational Site Number 203902	Liberec
Czech Republic	Investigational Site Number 203009	Olomouc
Czech Republic	Investigational Site Number 203010	Ostrava - Poruba
Czech Republic	Investigational Site Number 203001	Praha 10
Czech Republic	Investigational Site Number 203901	Praha 2
Czech Republic	Investigational Site Number 203003	Praha 5
Czech Republic	Investigational Site Number 203007	Praha 5
Czech Republic	Investigational Site Number 203002	Usti Nad Labem
Czech Republic	Investigational Site Number 203006	Zlin
Egypt	Investigational Site Number 818501	Cairo
Egypt	Investigational Site Number 818502	Cairo
Egypt	Investigational Site Number 818504	Cairo
Egypt	Investigational Site Number 818503	Giza
Estonia	Investigational Site Number 233001	Tallinn
Estonia	Investigational Site Number 233901	Tallinn
France	Investigational Site Number 250016	Avignon Cedex 2
France	Investigational Site Number 250010	Bayonne
France	Investigational Site Number 250002	Belfort Cedex
France	Investigational Site Number 250001	Besancon
France	Investigational Site Number 250006	Creteil
France	Investigational Site Number 250003	Dijon Cedex
France	Investigational Site Number 250013	Le Chesnay Cedex
France	Investigational Site Number 250012	Montfermeil
France	Investigational Site Number 250005	Mulhouse
France	Investigational Site Number 250015	Mulhouse
France	Investigational Site Number 250009	Paris
France	Investigational Site Number 250011	Pau
France	Investigational Site Number 250007	Rouen
France	Investigational Site Number 250014	Strasbourg
France	Investigational Site Number 250008	Toulouse Cedex 9
Germany	Investigational Site Number 276004	Berlin
Germany	Investigational Site Number 276022	Berlin
Germany	Investigational Site Number 276024	Berlin
Germany	Investigational Site Number 276023	Bonn
Germany	Investigational Site Number 276006	Frankfurt Am Main
Germany	Investigational Site Number 276901	Freiburg
Germany	Investigational Site Number 276003	Hamburg
Germany	Investigational Site Number 276902	Hamburg
Germany	Investigational Site Number 276009	Heidelberg
Germany	Investigational Site Number 276904	Heidenheim
Germany	Investigational Site Number 276002	Kassel
Germany	Investigational Site Number 276013	Langen
Germany	Investigational Site Number 276001	Mainz
Germany	Investigational Site Number 276905	Mönchengladbach
Germany	Investigational Site Number 276005	München
Germany	Investigational Site Number 276018	Rostock
Greece	Investigational Site Number 300009	Alexandroupolis
Greece	Investigational Site Number 300001	Athens
Greece	Investigational Site Number 300004	Athens
Greece	Investigational Site Number 300011	Athens
Greece	Investigational Site Number 300007	Chios
Greece	Investigational Site Number 300008	Larissa
Greece	Investigational Site Number 300003	Melissia
Greece	Investigational Site Number 300005	N. Ionia
Greece	Investigational Site Number 300002	Patras
Greece	Investigational Site Number 300006	Thessaloniki
Greece	Investigational Site Number 300010	Thessaloniki
Hong Kong	Investigational Site Number 344001	Chai Wan
Hungary	Investigational Site Number 348002	Budapest
Hungary	Investigational Site Number 348003	Budapest
Hungary	Investigational Site Number 348004	Budapest
Hungary	Investigational Site Number 348008	Budapest
Hungary	Investigational Site Number 348009	Szeged
Hungary	Investigational Site Number 348007	Szekesfehervar
Hungary	Investigational Site Number 348001	Szolnok
Hungary	Investigational Site Number 348005	Szombathely
Hungary	Investigational Site Number 348006	Zalaegerszeg
India	Investigational Site Number 356004	Ahmedabad
India	Investigational Site Number 356007	Ahmedabad
India	Investigational Site Number 356019	Ahmedabad
India	Investigational Site Number 356012	Allahabad
India	Investigational Site Number 356008	Bangalore
India	Investigational Site Number 356020	Chandigarh
India	Investigational Site Number 356027	Gurgaon
India	Investigational Site Number 356029	Gurgaon
India	Investigational Site Number 356040	Hyderabad
India	Investigational Site Number 356046	Hyderabad
India	Investigational Site Number 356014	Jaipur
India	Investigational Site Number 356003	Karamsad
India	Investigational Site Number 356037	Kochi
India	Investigational Site Number 356034	Kolkata
India	Investigational Site Number 356039	Madurai
India	Investigational Site Number 356018	Mangalore
India	Investigational Site Number 356016	Mumbai
India	Investigational Site Number 356021	Mumbai
India	Investigational Site Number 356031	Mumbai
India	Investigational Site Number 356032	Mumbai
India	Investigational Site Number 356011	Mysore
India	Investigational Site Number 356022	Nagpur
India	Investigational Site Number 356023	Nagpur
India	Investigational Site Number 356035	Nagpur
India	Investigational Site Number 356036	Nashik
India	Investigational Site Number 356001	New Delhi
India	Investigational Site Number 356025	New Delhi
India	Investigational Site Number 356026	New Delhi
India	Investigational Site Number 356010	Pune
India	Investigational Site Number 356033	Pune
India	Investigational Site Number 356024	Secunderabad
India	Investigational Site Number 356002	Varanasi
India	Investigational Site Number 356044	Vijaywada
Indonesia	Investigational Site Number 360505	Bandung
Indonesia	Investigational Site Number 360501	Depok
Indonesia	Investigational Site Number 360502	Jakarta
Indonesia	Investigational Site Number 360503	Jakarta
Indonesia	Investigational Site Number 360506	Jakarta
Israel	Investigational Site Number 376005	Afula
Israel	Investigational Site Number 376003	Ashkelon
Israel	Investigational Site Number 376011	Hadera
Israel	Investigational Site Number 376004	Haifa
Israel	Investigational Site Number 376009	Haifa
Israel	Investigational Site Number 376010	Holon
Israel	Investigational Site Number 376002	Jerusalem
Israel	Investigational Site Number 376013	Jerusalem
Israel	Investigational Site Number 376007	Safed
Israel	Investigational Site Number 376008	Tel Aviv
Israel	Investigational Site Number 376001	Tel Hashomer
Israel	Investigational Site Number 376012	Tzrifin
Italy	Investigational Site Number 380902	Bergamo
Italy	Investigational Site Number 380918	Bologna
Italy	Investigational Site Number 380904	Brescia
Italy	Investigational Site Number 380928	Brescia
Italy	Investigational Site Number 380929	Castellanza
Italy	Investigational Site Number 380912	Catania
Italy	Investigational Site Number 380930	Catania
Italy	Investigational Site Number 380932	Cittadella
Italy	Investigational Site Number 380926	Conegliano
Italy	Investigational Site Number 380909	Empoli
Italy	Investigational Site Number 380924	Forlì
Italy	Investigational Site Number 380908	Livorno
Italy	Investigational Site Number 380923	Massa
Italy	Investigational Site Number 380935	Massa
Italy	Investigational Site Number 380933	Messina
Italy	Investigational Site Number 380910	Milano
Italy	Investigational Site Number 380905	Modena
Italy	Investigational Site Number 380936	Napoli
Italy	Investigational Site Number 380901	Perugia
Italy	Investigational Site Number 380907	Pescara
Italy	Investigational Site Number 380919	Pordenone
Italy	Investigational Site Number 380916	Reggio Emilia
Italy	Investigational Site Number 380917	Roma
Italy	Investigational Site Number 380931	Roma
Italy	Investigational Site Number 380927	Rovigo
Italy	Investigational Site Number 380921	Rozzano
Italy	Investigational Site Number 380914	Seriate
Italy	Investigational Site Number 380925	Treviso
Jordan	Investigational Site Number 400501	Amman
Jordan	Investigational Site Number 400502	Irbid
Korea, Republic of	Investigational Site Number 410005	Busan
Korea, Republic of	Investigational Site Number 410006	Busan
Korea, Republic of	Investigational Site Number 410002	Daegu
Korea, Republic of	Investigational Site Number 410014	Daegu
Korea, Republic of	Investigational Site Number 410017	Daejeon
Korea, Republic of	Investigational Site Number 410004	Goyang
Korea, Republic of	Investigational Site Number 410018	Guri
Korea, Republic of	Investigational Site Number 410016	Gwangju
Korea, Republic of	Investigational Site Number 410007	Seongnam
Korea, Republic of	Investigational Site Number 410001	Seoul
Korea, Republic of	Investigational Site Number 410003	Seoul
Korea, Republic of	Investigational Site Number 410008	Seoul
Korea, Republic of	Investigational Site Number 410009	Seoul
Korea, Republic of	Investigational Site Number 410010	Seoul
Korea, Republic of	Investigational Site Number 410011	Seoul
Korea, Republic of	Investigational Site Number 410012	Seoul
Korea, Republic of	Investigational Site Number 410013	Suwon
Korea, Republic of	Investigational Site Number 410015	Wonju
Latvia	Investigational Site Number 428004	Daugavpils
Latvia	Investigational Site Number 428002	Liepaja
Latvia	Investigational Site Number 428001	Riga
Latvia	Investigational Site Number 428003	Riga
Lebanon	Investigational Site Number 422502	Beirut
Lebanon	Investigational Site Number 422505	Beirut
Lithuania	Investigational Site Number 440003	Kaunas
Lithuania	Investigational Site Number 440001	Siauliai
Lithuania	Investigational Site Number 440904	Vilnius
Macedonia, The Former Yugoslav R	Investigational Site Number 807501	Skopje
Malaysia	Investigational Site Number 458001	Kuching
Mexico	Investigational Site Number 484009	Aguascalientes
Mexico	Investigational Site Number 484907	Aguascalientes
Mexico	Investigational Site Number 484015	Guadalajara
Mexico	Investigational Site Number 484901	Guadalajara
Mexico	Investigational Site Number 484902	Guadalajara
Mexico	Investigational Site Number 484019	Merida
Mexico	Investigational Site Number 484003	Mexico City
Mexico	Investigational Site Number 484914	México Df
Mexico	Investigational Site Number 484004	Monterrey
Mexico	Investigational Site Number 484910	Morelia, Michoacan
Mexico	Investigational Site Number 484020	Puebla
Mexico	Investigational Site Number 484017	Queretaro
Mexico	Investigational Site Number 484012	San Luis Potosi
Mexico	Investigational Site Number 484911	San Luis Potosi
Mexico	Investigational Site Number 484013	Xalapa
Montenegro	Investigational Site Number 499501	Podgorica
Netherlands	Investigational Site Number 528003	Alkmaar
Netherlands	Investigational Site Number 528005	Arnhem
Netherlands	Investigational Site Number 528007	Leeuwarden
Netherlands	Investigational Site Number 528004	Nieuwegein
Netherlands	Investigational Site Number 528002	Rotterdam
New Zealand	Investigational Site Number 554004	Auckland
New Zealand	Investigational Site Number 554001	Hamilton
New Zealand	Investigational Site Number 554002	Nelson
Norway	Investigational Site Number 578903	Arendal
Norway	Investigational Site Number 578901	Bergen
Norway	Investigational Site Number 578902	Stavanger
Panama	Investigational Site Number 591504	Panama
Panama	Investigational Site Number 591502	Panamá
Peru	Investigational Site Number 604005	Lambayeque
Peru	Investigational Site Number 604002	Lima
Peru	Investigational Site Number 604003	Lima
Peru	Investigational Site Number 604006	Lima
Peru	Investigational Site Number 604008	Lima
Peru	Investigational Site Number 604011	Lima
Peru	Investigational Site Number 604012	Lima
Peru	Investigational Site Number 604014	Lima
Peru	Investigational Site Number 604017	Lima
Poland	Investigational Site Number 616005	Bialystok
Poland	Investigational Site Number 616038	Bialystok
Poland	Investigational Site Number 616017	Bydgoszcz
Poland	Investigational Site Number 616009	Bytom
Poland	Investigational Site Number 616040	Elblag
Poland	Investigational Site Number 616027	Elk
Poland	Investigational Site Number 616023	Gdansk
Poland	Investigational Site Number 616032	Jelenia Gora
Poland	Investigational Site Number 616037	Katowice
Poland	Investigational Site Number 616046	Katowice
Poland	Investigational Site Number 616034	Klodzko
Poland	Investigational Site Number 616002	Krakow
Poland	Investigational Site Number 616045	Krakow
Poland	Investigational Site Number 616029	Lodz
Poland	Investigational Site Number 616004	Lomza
Poland	Investigational Site Number 616024	Lubin
Poland	Investigational Site Number 616041	Lublin
Poland	Investigational Site Number 616016	Ostroleka
Poland	Investigational Site Number 616003	Radom
Poland	Investigational Site Number 616047	Radom
Poland	Investigational Site Number 616033	Rybnik
Poland	Investigational Site Number 616019	Tarnów
Poland	Investigational Site Number 616022	Torun
Poland	Investigational Site Number 616018	Walbrzych
Poland	Investigational Site Number 616001	Warszawa
Poland	Investigational Site Number 616014	Warszawa
Poland	Investigational Site Number 616031	Wloclawek
Poland	Investigational Site Number 616015	Wroclaw
Poland	Investigational Site Number 616020	Zamosc
Portugal	Investigational Site Number 620010	Almada
Portugal	Investigational Site Number 620006	Amadora
Portugal	Investigational Site Number 620001	Coimbra
Portugal	Investigational Site Number 620002	Coimbra
Portugal	Investigational Site Number 620011	Évora
Portugal	Investigational Site Number 620003	Lisboa
Portugal	Investigational Site Number 620015	Ponta Delgada
Portugal	Investigational Site Number 620004	Setúbal
Romania	Investigational Site Number 642002	Brasov
Romania	Investigational Site Number 642001	Bucuresti
Romania	Investigational Site Number 642004	Bucuresti
Romania	Investigational Site Number 642005	Cluj Napoca
Romania	Investigational Site Number 642003	Targu-Mures
Russian Federation	Investigational Site Number 643018	Barnaul
Russian Federation	Investigational Site Number 643015	Ekaterinburg
Russian Federation	Investigational Site Number 643011	Kemerovo
Russian Federation	Investigational Site Number 643014	Krasnodar
Russian Federation	Investigational Site Number 643021	Krasnoyarsk
Russian Federation	Investigational Site Number 643001	Moscow
Russian Federation	Investigational Site Number 643003	Moscow
Russian Federation	Investigational Site Number 643004	Moscow
Russian Federation	Investigational Site Number 643005	Moscow
Russian Federation	Investigational Site Number 643020	Moscow
Russian Federation	Investigational Site Number 643016	Nizniy Novgorod
Russian Federation	Investigational Site Number 643024	Novosibirsk
Russian Federation	Investigational Site Number 643008	Saint-Peterburg
Russian Federation	Investigational Site Number 643019	Saint-Petersburg
Russian Federation	Investigational Site Number 643013	Samara
Russian Federation	Investigational Site Number 643006	St-Petersburg
Russian Federation	Investigational Site Number 643007	St-Petersburg
Russian Federation	Investigational Site Number 643025	St-Petersburg
Russian Federation	Investigational Site Number 643012	Tomsk
Russian Federation	Investigational Site Number 643023	Volgograd
Russian Federation	Investigational Site Number 643017	Yaroslavl
Serbia	Investigational Site Number 688505	Belgrade
Serbia	Investigational Site Number 688501	Kragujevac
Serbia	Investigational Site Number 688503	Nis
Serbia	Investigational Site Number 688502	Sremska Kamenica
Serbia	Investigational Site Number 688504	Zemun
Serbia	Investigational Site Number 688506	Zemun
Singapore	Investigational Site Number 702001	Singapore
Singapore	Investigational Site Number 702002	Singapore
Slovakia	Investigational Site Number 703003	Banska Bystrica
Slovakia	Investigational Site Number 703002	Martin
Slovakia	Investigational Site Number 703001	Nitra
South Africa	Investigational Site Number 710004	Alberton
South Africa	Investigational Site Number 710001	Cape Town
South Africa	Investigational Site Number 710005	Cape Town
South Africa	Investigational Site Number 710003	Centurion
South Africa	Investigational Site Number 710002	Kuils River
South Africa	Investigational Site Number 710007	Pretoria
Spain	Investigational Site Number 724013	Alcorcón
Spain	Investigational Site Number 724001	Alicante
Spain	Investigational Site Number 724014	Badalona
Spain	Investigational Site Number 724002	Barcelona
Spain	Investigational Site Number 724021	Barcelona
Spain	Investigational Site Number 724022	Barcelona
Spain	Investigational Site Number 724025	Barcelona
Spain	Investigational Site Number 724901	Barcelona
Spain	Investigational Site Number 724007	Cáceres
Spain	Investigational Site Number 724026	Elche
Spain	Investigational Site Number 724016	Galdakao
Spain	Investigational Site Number 724023	Girona
Spain	Investigational Site Number 724006	La Laguna
Spain	Investigational Site Number 724003	Madrid
Spain	Investigational Site Number 724027	Madrid
Spain	Investigational Site Number 724902	Madrid
Spain	Investigational Site Number 724017	Málaga
Spain	Investigational Site Number 724904	Murcia
Spain	Investigational Site Number 724018	San Juan De Alicante
Spain	Investigational Site Number 724005	Santander
Spain	Investigational Site Number 724012	Santiago De Compostela
Spain	Investigational Site Number 724903	Terrassa
Spain	Investigational Site Number 724010	Torrevieja
Spain	Investigational Site Number 724024	Valencia
Switzerland	Investigational Site Number 756001	Lugano
Switzerland	Investigational Site Number 756002	Zürich
Taiwan	Investigational Site Number 158002	Kaohsiung
Taiwan	Investigational Site Number 158007	Kaohsiung
Taiwan	Investigational Site Number 158003	Linkou
Taiwan	Investigational Site Number 158008	Taichung
Taiwan	Investigational Site Number 158001	Taipei
Taiwan	Investigational Site Number 158009	Taipei
Taiwan	Investigational Site Number 158904	Taipei
Thailand	Investigational Site Number 764002	Bangkok
Thailand	Investigational Site Number 764005	Bangkok
Thailand	Investigational Site Number 764901	Bangkok
Thailand	Investigational Site Number 764004	Khon Kaen
Thailand	Investigational Site Number 764007	Klong Luang
Thailand	Investigational Site Number 764903	Muang
Thailand	Investigational Site Number 764006	Rajathavee
Tunisia	Investigational Site Number 788002	Ariana
Tunisia	Investigational Site Number 788005	Monastir
Tunisia	Investigational Site Number 788006	Monastir
Tunisia	Investigational Site Number 788001	Tunis
Tunisia	Investigational Site Number 788004	Tunis
Turkey	Investigational Site Number 792010	Adana
Turkey	Investigational Site Number 792023	Ankara
Turkey	Investigational Site Number 792009	Antalya
Turkey	Investigational Site Number 792008	Bursa
Turkey	Investigational Site Number 792022	Bursa
Turkey	Investigational Site Number 792030	Edirne
Turkey	Investigational Site Number 792006	Erzurum
Turkey	Investigational Site Number 792020	Eskisehir
Turkey	Investigational Site Number 792004	Gaziantep
Turkey	Investigational Site Number 792016	Istanbul
Turkey	Investigational Site Number 792018	Istanbul
Turkey	Investigational Site Number 792028	Istanbul
Turkey	Investigational Site Number 792029	Istanbul
Turkey	Investigational Site Number 792032	Istanbul
Turkey	Investigational Site Number 792001	Izmir
Turkey	Investigational Site Number 792003	Izmir
Turkey	Investigational Site Number 792011	Izmir
Turkey	Investigational Site Number 792012	Kayseri
Turkey	Investigational Site Number 792014	Kocaeli
Turkey	Investigational Site Number 792015	Konya
Turkey	Investigational Site Number 792025	Malatya
Turkey	Investigational Site Number 792019	Mersin
Turkey	Investigational Site Number 792021	Samsun
Turkey	Investigational Site Number 792026	Sivas
Ukraine	Investigational Site Number 804004	Cherkasy
Ukraine	Investigational Site Number 804001	Kharkiv
Ukraine	Investigational Site Number 804005	Lviv
Ukraine	Investigational Site Number 804003	Zaporozhie
United Kingdom	Investigational Site Number 826008	Bournemouth
United Kingdom	Investigational Site Number 826007	Bradford
United Kingdom	Investigational Site Number 826001	Craigavon
United Kingdom	Investigational Site Number 826005	East Kilbride
United Kingdom	Investigational Site Number 826002	Hull
United Kingdom	Investigational Site Number 826006	Manchester
United Kingdom	Investigational Site Number 826003	St Leonards
United States	Investigational Site Number 840534	Alexandria	Louisiana
United States	Investigational Site Number 840023	Amarillo	Texas
United States	Investigational Site Number 840904	Ames	Iowa
United States	Investigational Site Number 840101	Anaheim	California
United States	Investigational Site Number 840151	Anaheim	California
United States	Investigational Site Number 840105	Aurora	Illinois
United States	Investigational Site Number 840203	Austin	Texas
United States	Investigational Site Number 840574	Austin	Texas
United States	Investigational Site Number 840213	Beverley Hills	California
United States	Investigational Site Number 840532	Boise	Idaho
United States	Investigational Site Number 840551	Bridgeport	Connecticut
United States	Investigational Site Number 840208	Bridgeton	Missouri
United States	Investigational Site Number 840518	Brooklyn	New York
United States	Investigational Site Number 840540	Chambersburg	Pennsylvania
United States	Investigational Site Number 840585	Charlotte	North Carolina
United States	Investigational Site Number 840190	Chicago	Illinois
United States	Investigational Site Number 840205	Chicago	Illinois
United States	Investigational Site Number 840060	Dallas	Texas
United States	Investigational Site Number 840578	Dallas	Texas
United States	Investigational Site Number 840517	Dearborn	Michigan
United States	Investigational Site Number 840519	Doylestown	Pennsylvania
United States	Investigational Site Number 840003	Erie	Pennsylvania
United States	Investigational Site Number 840206	Eugene	Oregon
United States	Investigational Site Number 840185	Fort Lauderdale	Florida
United States	Investigational Site Number 840715	Fort Worth	Texas
United States	Investigational Site Number 840719	Gainesville	Georgia
United States	Investigational Site Number 840515	Greenville	North Carolina
United States	Investigational Site Number 840042	Hammond	Indiana
United States	Investigational Site Number 840098	Harrisburg	Pennsylvania
United States	Investigational Site Number 840521	Harvey	Illinois
United States	Investigational Site Number 840090	Houston	Texas
United States	Investigational Site Number 840207	Houston	Texas
United States	Investigational Site Number 840559	Houston	Texas
United States	Investigational Site Number 840586	Houston	Texas
United States	Investigational Site Number 840572	Huntington Beach	California
United States	Investigational Site Number 840015	Huntsville	Alabama
United States	Investigational Site Number 840209	Independence	Missouri
United States	Investigational Site Number 840554	Indianapolis	Indiana
United States	Investigational Site Number 840028	Jacksonville	Florida
United States	Investigational Site Number 840148	Joliet	Illinois
United States	Investigational Site Number 840544	Kalamazoo	Michigan
United States	Investigational Site Number 840529	Kalispell	Montana
United States	Investigational Site Number 840056	Kansas City	Missouri
United States	Investigational Site Number 840138	Kansas City	Missouri
United States	Investigational Site Number 840194	Kansas City	Missouri
United States	Investigational Site Number 840564	Lake Charles	Louisiana
United States	Investigational Site Number 840047	Lake Mary	Florida
United States	Investigational Site Number 840721	Littleton	Colorado
United States	Investigational Site Number 840201	Long Beach	California
United States	Investigational Site Number 840071	Los Angeles	California
United States	Investigational Site Number 840557	Los Angeles	California
United States	Investigational Site Number 840568	Louisville	Kentucky
United States	Investigational Site Number 840513	Manitowoc	Wisconsin
United States	Investigational Site Number 840500	Melbourne	Florida
United States	Investigational Site Number 840706	Miami	Florida
United States	Investigational Site Number 840025	Midwest City	Oklahoma
United States	Investigational Site Number 840510	Minneapolis	Minnesota
United States	Investigational Site Number 840525	Minneapolis	Minnesota
United States	Investigational Site Number 840136	Minot	North Dakota
United States	Investigational Site Number 840560	Muncie	Indiana
United States	Investigational Site Number 840166	New Haven	Connecticut
United States	Investigational Site Number 840533	New Orleans	Louisiana
United States	Investigational Site Number 840539	New York	New York
United States	Investigational Site Number 840903	Northridge	California
United States	Investigational Site Number 840072	Oak Ridge	Tennessee
United States	Investigational Site Number 840009	Ocala	Florida
United States	Investigational Site Number 840146	Ocala	Florida
United States	Investigational Site Number 840049	Oklahoma City	Oklahoma
United States	Investigational Site Number 840193	Oklahoma City	Oklahoma
United States	Investigational Site Number 840905	Oklahoma City	Oklahoma
United States	Investigational Site Number 840059	Omaha	Nebraska
United States	Investigational Site Number 840079	Omaha	Nebraska
United States	Investigational Site Number 840727	Omaha	Nebraska
United States	Investigational Site Number 840577	Orlando	Florida
United States	Investigational Site Number 840912	Overland	Kansas
United States	Investigational Site Number 840573	Philadelphia	Pennsylvania
United States	Investigational Site Number 840569	Phoenix	Arizona
United States	Investigational Site Number 840703	Phoenix	Arizona
United States	Investigational Site Number 840075	Pittsburgh	Pennsylvania
United States	Investigational Site Number 840911	Pittsburgh	Pennsylvania
United States	Investigational Site Number 840566	Raleigh	North Carolina
United States	Investigational Site Number 840157	Reno	Nevada
United States	Investigational Site Number 840188	Richmond	Virginia
United States	Investigational Site Number 840553	Richmond	Virginia
United States	Investigational Site Number 840531	Saginaw	Michigan
United States	Investigational Site Number 840165	Salem	Virginia
United States	Investigational Site Number 840065	San Francisco	California
United States	Investigational Site Number 840561	Santa Rosa	California
United States	Investigational Site Number 840021	Sarasota	Florida
United States	Investigational Site Number 840530	St Louis	Missouri
United States	Investigational Site Number 840580	St Louis	Missouri
United States	Investigational Site Number 840052	St. Louis	Missouri
United States	Investigational Site Number 840210	St. Louis	Missouri
United States	Investigational Site Number 840902	St. Petersburg	Florida
United States	Investigational Site Number 840121	Tacoma	Washington
United States	Investigational Site Number 840508	Tampa	Florida
United States	Investigational Site Number 840082	Toledo	Ohio
United States	Investigational Site Number 840901	Tulsa	Oklahoma
United States	Investigational Site Number 840527	Tupelo	Mississippi
United States	Investigational Site Number 840087	Tyler	Texas
United States	Investigational Site Number 840910	Victoria	Texas
United States	Investigational Site Number 840211	Washington	Pennsylvania
United States	Investigational Site Number 840520	Washington	District of Columbia
United States	Investigational Site Number 840058	West Des Moines	Iowa
United States	Investigational Site Number 840555	Wichita Falls	Texas
United States	Investigational Site Number 840565	Winchester	Virginia
United States	Investigational Site Number 840908	Winston Salem	North Carolina
Vietnam	Investigational Site Number 704006	Hanoi
Vietnam	Investigational Site Number 704001	Ho Chi Minh City
Vietnam	Investigational Site Number 704003	Ho Chi Minh City
Vietnam	Investigational Site Number 704004	Ho Chi Minh City
Vietnam	Investigational Site Number 704005	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czech Republic,  Egypt,  Estonia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Indonesia,  Israel,  Italy,  Jordan,  Korea, Republic of,  Latvia,  Lebanon,  Lithuania,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Mexico,  Montenegro,  Netherlands,  New Zealand,  Norway,  Panama,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  Tunisia,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction		from randomization (day 1) to day 7	No
Primary	Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)		from day 1 to day 7	Yes
Secondary	Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke		from day 1 to day 7	No
Secondary	Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction		from day 1 to day 30	No
Secondary	Adjudicated all-cause death		from day 1 to day 30	No
Secondary	Adjudicated Procedural thrombotic complications during the index PCI		during index PCI	No