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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00580216
Other study ID # EFC10295
Secondary ID 2007-004817-33
Status Terminated
Phase Phase 3
First received December 21, 2007
Last updated February 26, 2014
Start date December 2007
Est. completion date October 2010

Study information

Verified date February 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationRussia: Pharmacological Committee, Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)
Study type Interventional

Clinical Trial Summary

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).


Description:

The end of the study is defined by a common study end date for all participants, defined as 9 months (39 weeks) after the last participant randomized.

All participants will receive oral warfarin (or matching placebo) and weekly SC injections of idrabiotaparinux (or matching placebo) up to 6 months before the common study end date. All participants are expected to be treated for at least 6 months.

All participants will have then an 6-month observational period after cessation of study treatment.


Recruitment information / eligibility

Status Terminated
Enrollment 3773
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Non valvular atrial fibrillation (AF)

- Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age > or = 75 years, diabetes mellitus.

Main exclusion Criteria:

- Indication for VKA other than AF

- Stroke or TIA within previous 5 days

- Transient AF caused by a reversible disorder

- Planned major surgery/trauma or cardioversion within 30 days

- INR > 3 at baseline

- Active bleeding or high risk of bleeding

- Uncontrolled hypertension

- Pregnancy or childbearing potential without proper contraceptive measures or breast feeding.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Idrabiotaparinux
Pre-filled syringes containing: 0.5 mL for the 3.0 mg dosage; 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old); 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age =75 years). Subcutaneous injection
Warfarin
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration
Placebo (for idrabiotaparinux)
Matching pre-filled syringes containing: 0.5 mL for the 3.0 mg dosage; 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old); 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age =75 years). Subcutaneous injection
Placebo (for warfarin)
Warfarin matching capsules Oral administration
Avidin
Vial containing 105 mg of lyophilized powder for dilution Intravenous infusion for 30 minutes
Placebo (for avidin)
Vial containing 105 mg of matching lyophilized powder for dissolution Intravenous infusion for 30 minutes

Locations

Country Name City State
Argentina Sanofi-Aventis Investigational Site Number 032001 Buenos Aires
Argentina Sanofi-Aventis Investigational Site Number 032005 Buenos Aires
Argentina Sanofi-Aventis Investigational Site Number 032007 Buenos Aires
Argentina Sanofi-Aventis Investigational Site Number 032011 Buenos Aires
Argentina Sanofi-Aventis Investigational Site Number 032009 Capital Federal
Argentina Sanofi-Aventis Investigational Site Number 032012 Corrientes
Argentina Sanofi-Aventis Investigational Site Number 032006 Mar Del Plata
Argentina Sanofi-Aventis Investigational Site Number 032014 Moron
Argentina Sanofi-Aventis Investigational Site Number 032016 Salta
Argentina Sanofi-Aventis Investigational Site Number 032010 Zarate
Australia Sanofi-Aventis Investigational Site Number 036006 Adelaide
Australia Sanofi-Aventis Investigational Site Number 036003 Auchenflower
Australia Sanofi-Aventis Investigational Site Number 036008 Box Hill
Australia Sanofi-Aventis Investigational Site Number 036005 Coffs Harbour
Australia Sanofi-Aventis Investigational Site Number 036001 Kippa Ring
Australia Sanofi-Aventis Investigational Site Number 036002 Kippa Ring
Australia Sanofi-Aventis Investigational Site Number 036009 Launceston
Australia Sanofi-Aventis Investigational Site Number 036010 Woden
Austria Sanofi-Aventis Investigational Site Number 040001 Graz
Austria Sanofi-Aventis Investigational Site Number 040004 Linz
Belarus Sanofi-Aventis Investigational Site Number 112001 Minsk
Belarus Sanofi-Aventis Investigational Site Number 112002 Minsk
Belarus Sanofi-Aventis Investigational Site Number 112003 Minsk
Belarus Sanofi-Aventis Investigational Site Number 112005 Minsk
Brazil Sanofi-Aventis Investigational Site Number 076019 Belo Horizonte
Brazil Sanofi-Aventis Investigational Site Number 076011 Campina Grande Do Sul
Brazil Sanofi-Aventis Investigational Site Number 076007 Campinas
Brazil Sanofi-Aventis Investigational Site Number 076013 Campinas
Brazil Sanofi-Aventis Investigational Site Number 076001 Curitiba
Brazil Sanofi-Aventis Investigational Site Number 076016 Goiania
Brazil Sanofi-Aventis Investigational Site Number 076017 Goiania
Brazil Sanofi-Aventis Investigational Site Number 076018 Maceio
Brazil Sanofi-Aventis Investigational Site Number 076008 Porto Alegre
Brazil Sanofi-Aventis Investigational Site Number 076012 Porto Alegre
Brazil Sanofi-Aventis Investigational Site Number 076014 Porto Alegre
Brazil Sanofi-Aventis Investigational Site Number 076009 Recife
Brazil Sanofi-Aventis Investigational Site Number 076005 Sao Jose Do Rio Preto
Brazil Sanofi-Aventis Investigational Site Number 076010 Sao Paulo
Brazil Sanofi-Aventis Investigational Site Number 076015 Uberlandia
Bulgaria Sanofi-Aventis Investigational Site Number 100004 Pleven
Bulgaria Sanofi-Aventis Investigational Site Number 100005 Plovdiv
Bulgaria Sanofi-Aventis Investigational Site Number 100001 Sofia
Bulgaria Sanofi-Aventis Investigational Site Number 100002 Sofia
Bulgaria Sanofi-Aventis Investigational Site Number 100003 Sofia
Canada Sanofi-Aventis Investigational Site Number 124014 London
Canada Sanofi-Aventis Investigational Site Number 124006 Newmarket
Canada Sanofi-Aventis Investigational Site Number 124012 Quebec
Canada Sanofi-Aventis Investigational Site Number 124011 Toronto
Chile Sanofi-Aventis Investigational Site Number 152001 Santiago
Chile Sanofi-Aventis Investigational Site Number 152003 Santiago
Chile Sanofi-Aventis Investigational Site Number 152004 Santiago
Chile Sanofi-Aventis Investigational Site Number 152005 Santiago
Chile Sanofi-Aventis Investigational Site Number 152007 Santiago
Chile Sanofi-Aventis Investigational Site Number 152008 Santiago
Chile Sanofi-Aventis Investigational Site Number 152006 Viña Del Mar
Chile Sanofi-Aventis Investigational Site Number 152009 Viña Del Mar
Colombia Sanofi-Aventis Investigational Site Number 170003 Bogota
Colombia Sanofi-Aventis Investigational Site Number 170006 Bogota
Colombia Sanofi-Aventis Investigational Site Number 170001 Bucaramanga
Colombia Sanofi-Aventis Investigational Site Number 170005 Envigado-Antioquia
Colombia Sanofi-Aventis Investigational Site Number 170002 Medellin
Costa Rica Sanofi-Aventis Investigational Site Number 188004 San José
Croatia Sanofi-Aventis Investigational Site Number 191003 Split
Croatia Sanofi-Aventis Investigational Site Number 191001 Zagreb
Croatia Sanofi-Aventis Investigational Site Number 191004 Zagreb
Czech Republic Sanofi-Aventis Investigational Site Number 203005 Chomutov
Czech Republic Sanofi-Aventis Investigational Site Number 203003 Jihlava
Czech Republic Sanofi-Aventis Investigational Site Number 203009 Ostrava Vitkovice
Czech Republic Sanofi-Aventis Investigational Site Number 203001 Pardubice
Czech Republic Sanofi-Aventis Investigational Site Number 203011 Plzen - Bory
Czech Republic Sanofi-Aventis Investigational Site Number 203002 Praha 2
Czech Republic Sanofi-Aventis Investigational Site Number 203004 Praha 4
Czech Republic Sanofi-Aventis Investigational Site Number 203010 Praha 6
Czech Republic Sanofi-Aventis Investigational Site Number 203006 Prostejov
Czech Republic Sanofi-Aventis Investigational Site Number 203008 Usti Nad Orlici
Denmark Sanofi-Aventis Investigational Site Number 208002 Glostrup
Denmark Sanofi-Aventis Investigational Site Number 208001 Hellerup
Denmark Sanofi-Aventis Investigational Site Number 208007 Hvidovre
Denmark Sanofi-Aventis Investigational Site Number 208003 København S
Denmark Sanofi-Aventis Investigational Site Number 208004 Odense
Denmark Sanofi-Aventis Investigational Site Number 208006 Roskilde
Denmark Sanofi-Aventis Investigational Site Number 208005 Svendborg
Egypt Sanofi-Aventis Investigational Site Number 818002 Alexandria
Egypt Sanofi-Aventis Investigational Site Number 818003 Alexandria
Egypt Sanofi-Aventis Investigational Site Number 818004 Alexandria
Egypt Sanofi-Aventis Investigational Site Number 818001 Cairo
Estonia Sanofi-Aventis Investigational Site Number 233001 Tallinn
Estonia Sanofi-Aventis Investigational Site Number 233003 Tallinn
Estonia Sanofi-Aventis Investigational Site Number 233004 Tallinn
Estonia Sanofi-Aventis Investigational Site Number 233002 Tartu
Finland Sanofi-Aventis Investigational Site Number 246001 Helsinki
France Sanofi-Aventis Investigational Site Number 250028 Abbeville
France Sanofi-Aventis Investigational Site Number 250012 Albi Cedex 9
France Sanofi-Aventis Investigational Site Number 250034 Allauch
France Sanofi-Aventis Investigational Site Number 250031 Belfort Cedex
France Sanofi-Aventis Investigational Site Number 250011 Bordeaux
France Sanofi-Aventis Investigational Site Number 250021 Brest
France Sanofi-Aventis Investigational Site Number 250010 Brest Cedex 2
France Sanofi-Aventis Investigational Site Number 250035 Bron
France Sanofi-Aventis Investigational Site Number 250022 Cholet Cedex
France Sanofi-Aventis Investigational Site Number 250006 Dijon
France Sanofi-Aventis Investigational Site Number 250018 Dijon Cedex
France Sanofi-Aventis Investigational Site Number 250004 La Rochelle
France Sanofi-Aventis Investigational Site Number 250029 Le Chesnay Cedex
France Sanofi-Aventis Investigational Site Number 250015 Lille
France Sanofi-Aventis Investigational Site Number 250019 Lille
France Sanofi-Aventis Investigational Site Number 250030 Metz Tessy
France Sanofi-Aventis Investigational Site Number 250003 Montpellier
France Sanofi-Aventis Investigational Site Number 250032 Montpellier
France Sanofi-Aventis Investigational Site Number 250016 Nice Cedex
France Sanofi-Aventis Investigational Site Number 250001 Paris
France Sanofi-Aventis Investigational Site Number 250014 Paris Cedex 13
France Sanofi-Aventis Investigational Site Number 250008 Paris Cedex 14
France Sanofi-Aventis Investigational Site Number 250005 Saint Etienne Cedex 2
France Sanofi-Aventis Investigational Site Number 250026 Toulouse Cedex 9
France Sanofi-Aventis Investigational Site Number 250027 Tours Cedex 1
France Sanofi-Aventis Investigational Site Number 250002 Vandoeuvre Les Nancy Cedex
Greece Sanofi-Aventis Investigational Site Number 300002 Athens
Greece Sanofi-Aventis Investigational Site Number 300005 Athens
Greece Sanofi-Aventis Investigational Site Number 300007 Athens
Greece Sanofi-Aventis Investigational Site Number 300009 Athens
Greece Sanofi-Aventis Investigational Site Number 300006 Chalkida
Greece Sanofi-Aventis Investigational Site Number 300004 Chios
Greece Sanofi-Aventis Investigational Site Number 300008 Elefsina
Guatemala Sanofi-Aventis Investigational Site Number 320001 Guatemala
Guatemala Sanofi-Aventis Investigational Site Number 320002 Guatemala
Guatemala Sanofi-Aventis Investigational Site Number 320003 Guatemala
Guatemala Sanofi-Aventis Investigational Site Number 320004 Guatemala
India Sanofi-Aventis Investigational Site Number 356001 Ahmedabad
India Sanofi-Aventis Investigational Site Number 356010 Ahmedabad
India Sanofi-Aventis Investigational Site Number 356009 Bangalore
India Sanofi-Aventis Investigational Site Number 356015 Bangalore
India Sanofi-Aventis Investigational Site Number 356005 Chennai
India Sanofi-Aventis Investigational Site Number 356002 Coimbatore
India Sanofi-Aventis Investigational Site Number 356007 Coimbatore
India Sanofi-Aventis Investigational Site Number 356006 Lucknow
India Sanofi-Aventis Investigational Site Number 356013 Lucknow
India Sanofi-Aventis Investigational Site Number 356017 Mumbai
India Sanofi-Aventis Investigational Site Number 356014 Mysore
India Sanofi-Aventis Investigational Site Number 356020 Nashik
India Sanofi-Aventis Investigational Site Number 356004 New Delhi
India Sanofi-Aventis Investigational Site Number 356012 New Delhi
India Sanofi-Aventis Investigational Site Number 356011 Pune
India Sanofi-Aventis Investigational Site Number 356018 Pune.
India Sanofi-Aventis Investigational Site Number 356003 Secunderabad
Indonesia Sanofi-Aventis Investigational Site Number 360001 Jakarta
Indonesia Sanofi-Aventis Investigational Site Number 360002 Jakarta
Israel Sanofi-Aventis Investigational Site Number 376003 Afula
Israel Sanofi-Aventis Investigational Site Number 376015 Ashkelon
Israel Sanofi-Aventis Investigational Site Number 376001 Givatayim
Israel Sanofi-Aventis Investigational Site Number 376007 Haifa
Israel Sanofi-Aventis Investigational Site Number 376014 Haifa
Israel Sanofi-Aventis Investigational Site Number 376004 Holon
Israel Sanofi-Aventis Investigational Site Number 376012 Nahariya
Israel Sanofi-Aventis Investigational Site Number 376009 Nazareth
Israel Sanofi-Aventis Investigational Site Number 376011 Rehovot
Israel Sanofi-Aventis Investigational Site Number 376002 Tel Aviv
Italy Sanofi-Aventis Investigational Site Number 380015 Ascoli Piceno
Italy Sanofi-Aventis Investigational Site Number 380018 Borgo San Lorenzo
Italy Sanofi-Aventis Investigational Site Number 380016 Chieti
Italy Sanofi-Aventis Investigational Site Number 380005 Fidenza
Italy Sanofi-Aventis Investigational Site Number 380010 Merate
Italy Sanofi-Aventis Investigational Site Number 380014 Milano
Italy Sanofi-Aventis Investigational Site Number 380020 Novara
Italy Sanofi-Aventis Investigational Site Number 380001 Padova
Italy Sanofi-Aventis Investigational Site Number 380007 Padova
Italy Sanofi-Aventis Investigational Site Number 380004 Palermo
Italy Sanofi-Aventis Investigational Site Number 380008 Pavia
Italy Sanofi-Aventis Investigational Site Number 380021 Perugia
Italy Sanofi-Aventis Investigational Site Number 380013 San Daniele Del Friuli
Italy Sanofi-Aventis Investigational Site Number 380003 Sassari
Italy Sanofi-Aventis Investigational Site Number 380011 Torino
Italy Sanofi-Aventis Investigational Site Number 380009 Treviso
Korea, Republic of Sanofi-Aventis Investigational Site Number 410008 Anyang
Korea, Republic of Sanofi-Aventis Investigational Site Number 410002 Daegu
Korea, Republic of Sanofi-Aventis Investigational Site Number 410006 Goyang
Korea, Republic of Sanofi-Aventis Investigational Site Number 410012 Goyang
Korea, Republic of Sanofi-Aventis Investigational Site Number 410007 Gwangju
Korea, Republic of Sanofi-Aventis Investigational Site Number 410003 Seongnam
Korea, Republic of Sanofi-Aventis Investigational Site Number 410001 Seoul
Korea, Republic of Sanofi-Aventis Investigational Site Number 410004 Seoul
Korea, Republic of Sanofi-Aventis Investigational Site Number 410005 Seoul
Korea, Republic of Sanofi-Aventis Investigational Site Number 410011 Seoul
Lithuania Sanofi-Aventis Investigational Site Number 440002 Kaunas
Lithuania Sanofi-Aventis Investigational Site Number 440004 Kaunas
Lithuania Sanofi-Aventis Investigational Site Number 440001 Vilnius
Lithuania Sanofi-Aventis Investigational Site Number 440003 Vilnius
Malaysia Sanofi-Aventis Investigational Site Number 458001 Kuching
Malaysia Sanofi-Aventis Investigational Site Number 458002 Penang
Malaysia Sanofi-Aventis Investigational Site Number 458005 Taiping
Mexico Sanofi-Aventis Investigational Site Number 484008 Acapulco
Mexico Sanofi-Aventis Investigational Site Number 484013 Aguascalientes
Mexico Sanofi-Aventis Investigational Site Number 484016 Aguascalientes
Mexico Sanofi-Aventis Investigational Site Number 484004 Guadalajara
Mexico Sanofi-Aventis Investigational Site Number 484007 Guadalajara
Mexico Sanofi-Aventis Investigational Site Number 484012 Mexico Df
Mexico Sanofi-Aventis Investigational Site Number 484010 Monterrey
Mexico Sanofi-Aventis Investigational Site Number 484005 San Luis Potosi
Mexico Sanofi-Aventis Investigational Site Number 484011 San Luis Potosi
Mexico Sanofi-Aventis Investigational Site Number 484003 Veracruz
Morocco Sanofi-Aventis Investigational Site Number 504001 Marrakech
Morocco Sanofi-Aventis Investigational Site Number 504002 Meknes
Netherlands Sanofi-Aventis Investigational Site Number 528012 Almelo
Netherlands Sanofi-Aventis Investigational Site Number 528030 Amsterdam
Netherlands Sanofi-Aventis Investigational Site Number 528026 Breda
Netherlands Sanofi-Aventis Investigational Site Number 528009 Delft
Netherlands Sanofi-Aventis Investigational Site Number 528035 Den Haag
Netherlands Sanofi-Aventis Investigational Site Number 528027 Ede
Netherlands Sanofi-Aventis Investigational Site Number 528006 Eindhoven
Netherlands Sanofi-Aventis Investigational Site Number 528017 Eindhoven
Netherlands Sanofi-Aventis Investigational Site Number 528016 Gouda
Netherlands Sanofi-Aventis Investigational Site Number 528007 Harderwijk
Netherlands Sanofi-Aventis Investigational Site Number 528001 Heerlen
Netherlands Sanofi-Aventis Investigational Site Number 528024 Heerlen
Netherlands Sanofi-Aventis Investigational Site Number 528003 Hengelo
Netherlands Sanofi-Aventis Investigational Site Number 528010 Hengelo
Netherlands Sanofi-Aventis Investigational Site Number 528031 Hoogeveen
Netherlands Sanofi-Aventis Investigational Site Number 528019 Hoorn
Netherlands Sanofi-Aventis Investigational Site Number 528020 Leeuwarden
Netherlands Sanofi-Aventis Investigational Site Number 528004 Nijmegen
Netherlands Sanofi-Aventis Investigational Site Number 528013 Rotterdam
Netherlands Sanofi-Aventis Investigational Site Number 528022 Sittard-Geleen
Netherlands Sanofi-Aventis Investigational Site Number 528002 Sneek
Netherlands Sanofi-Aventis Investigational Site Number 528033 Tilburg
Netherlands Sanofi-Aventis Investigational Site Number 528021 Venlo
Netherlands Sanofi-Aventis Investigational Site Number 528005 Zoetermeer
Netherlands Sanofi-Aventis Investigational Site Number 528025 Zwolle
New Zealand Sanofi-Aventis Investigational Site Number 554003 Christchurch
New Zealand Sanofi-Aventis Investigational Site Number 554002 Dunedin
New Zealand Sanofi-Aventis Investigational Site Number 554001 Nelson
Norway Sanofi-Aventis Investigational Site Number 578001 Bergen
Norway Sanofi-Aventis Investigational Site Number 578006 Flekkefjord
Norway Sanofi-Aventis Investigational Site Number 578005 Lørenskog
Norway Sanofi-Aventis Investigational Site Number 578004 Oslo
Panama Sanofi-Aventis Investigational Site Number 591001 Panama
Panama Sanofi-Aventis Investigational Site Number 591002 Panama
Panama Sanofi-Aventis Investigational Site Number 591003 Panama
Peru Sanofi-Aventis Investigational Site Number 604001 Lima
Peru Sanofi-Aventis Investigational Site Number 604002 Lima
Peru Sanofi-Aventis Investigational Site Number 604003 Lima
Peru Sanofi-Aventis Investigational Site Number 604004 Lima
Peru Sanofi-Aventis Investigational Site Number 604005 Lima
Philippines Sanofi-Aventis Investigational Site Number 608001 Quezon City
Poland Sanofi-Aventis Investigational Site Number 616013 Chojnice
Poland Sanofi-Aventis Investigational Site Number 616011 Gdansk
Poland Sanofi-Aventis Investigational Site Number 616014 Gdynia-Redlowo
Poland Sanofi-Aventis Investigational Site Number 616009 Katowice
Poland Sanofi-Aventis Investigational Site Number 616017 Lodz
Poland Sanofi-Aventis Investigational Site Number 616002 Lublin
Poland Sanofi-Aventis Investigational Site Number 616012 Ostrowiec Swietokrzyski
Poland Sanofi-Aventis Investigational Site Number 616015 Pulawy
Poland Sanofi-Aventis Investigational Site Number 616007 Torun
Poland Sanofi-Aventis Investigational Site Number 616006 Tychy
Poland Sanofi-Aventis Investigational Site Number 616001 Warszawa
Poland Sanofi-Aventis Investigational Site Number 616010 Warszawa
Poland Sanofi-Aventis Investigational Site Number 616008 Wroclaw
Portugal Sanofi-Aventis Investigational Site Number 620002 Amadora
Portugal Sanofi-Aventis Investigational Site Number 620007 Braga
Portugal Sanofi-Aventis Investigational Site Number 620006 Coimbra
Portugal Sanofi-Aventis Investigational Site Number 620008 Setubal
Puerto Rico Sanofi-Aventis Investigational Site Number 630001 San Juan
Russian Federation Sanofi-Aventis Investigational Site Number 643033 Barnaul
Russian Federation Sanofi-Aventis Investigational Site Number 643036 Chelyabinsk
Russian Federation Sanofi-Aventis Investigational Site Number 643040 Chelyabinsk
Russian Federation Sanofi-Aventis Investigational Site Number 643050 Chelyabinsk
Russian Federation Sanofi-Aventis Investigational Site Number 643031 Ekaterinburg
Russian Federation Sanofi-Aventis Investigational Site Number 643009 Kemerovo
Russian Federation Sanofi-Aventis Investigational Site Number 643042 Kemerovo
Russian Federation Sanofi-Aventis Investigational Site Number 643001 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643007 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643011 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643015 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643020 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643025 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643026 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643028 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643030 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643032 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643034 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643037 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643039 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643049 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643052 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643053 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643054 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643056 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643013 Nizhny Novgorod
Russian Federation Sanofi-Aventis Investigational Site Number 643041 Nizniy Novgorod
Russian Federation Sanofi-Aventis Investigational Site Number 643044 Novosibirsk
Russian Federation Sanofi-Aventis Investigational Site Number 643051 Novosibirsk
Russian Federation Sanofi-Aventis Investigational Site Number 643048 Novosibirsk-117
Russian Federation Sanofi-Aventis Investigational Site Number 643045 Penza
Russian Federation Sanofi-Aventis Investigational Site Number 643006 Perm
Russian Federation Sanofi-Aventis Investigational Site Number 643023 Perm
Russian Federation Sanofi-Aventis Investigational Site Number 643046 Petrozavodsk
Russian Federation Sanofi-Aventis Investigational Site Number 643012 Rostov-Na-Donu
Russian Federation Sanofi-Aventis Investigational Site Number 643008 Ryazan
Russian Federation Sanofi-Aventis Investigational Site Number 643017 Saint-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643047 Saint-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643029 Samara
Russian Federation Sanofi-Aventis Investigational Site Number 643003 Saratov
Russian Federation Sanofi-Aventis Investigational Site Number 643004 Saratov
Russian Federation Sanofi-Aventis Investigational Site Number 643005 Saratov
Russian Federation Sanofi-Aventis Investigational Site Number 643002 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643010 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643016 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643018 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643022 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643027 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643038 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643024 Tomsk
Russian Federation Sanofi-Aventis Investigational Site Number 643035 Tomsk
Russian Federation Sanofi-Aventis Investigational Site Number 643021 Tyumen
Russian Federation Sanofi-Aventis Investigational Site Number 643043 Voronezh
Russian Federation Sanofi-Aventis Investigational Site Number 643019 Yaroslavl
Slovakia Sanofi-Aventis Investigational Site Number 703003 Kosice
Slovakia Sanofi-Aventis Investigational Site Number 703005 Levice
Slovakia Sanofi-Aventis Investigational Site Number 703004 Nitra
Slovakia Sanofi-Aventis Investigational Site Number 703006 Poprad
Slovakia Sanofi-Aventis Investigational Site Number 703002 Trnava
South Africa Sanofi-Aventis Investigational Site Number 710013 Amanzimtoti
South Africa Sanofi-Aventis Investigational Site Number 710011 Bloemfontein
South Africa Sanofi-Aventis Investigational Site Number 710007 Cape Town
South Africa Sanofi-Aventis Investigational Site Number 710017 Cape Town
South Africa Sanofi-Aventis Investigational Site Number 710001 Durban
South Africa Sanofi-Aventis Investigational Site Number 710012 Durban
South Africa Sanofi-Aventis Investigational Site Number 710009 Johannesburg
South Africa Sanofi-Aventis Investigational Site Number 710016 Port Elizabeth
South Africa Sanofi-Aventis Investigational Site Number 710002 Pretoria
South Africa Sanofi-Aventis Investigational Site Number 710003 Pretoria
South Africa Sanofi-Aventis Investigational Site Number 710020 Pretoria
South Africa Sanofi-Aventis Investigational Site Number 710015 Randburg
South Africa Sanofi-Aventis Investigational Site Number 710014 Scottburgh
South Africa Sanofi-Aventis Investigational Site Number 710018 Umhlanga Rocks
Spain Sanofi-Aventis Investigational Site Number 724002 Barcelona
Spain Sanofi-Aventis Investigational Site Number 724003 Barcelona
Spain Sanofi-Aventis Investigational Site Number 724001 Madrid
Spain Sanofi-Aventis Investigational Site Number 724005 Santiago De Compostela
Spain Sanofi-Aventis Investigational Site Number 724007 Sevilla
Sweden Sanofi-Aventis Investigational Site Number 752003 Göteborg
Sweden Sanofi-Aventis Investigational Site Number 752006 Göteborg
Sweden Sanofi-Aventis Investigational Site Number 752007 Malmo
Sweden Sanofi-Aventis Investigational Site Number 752002 Malmö
Sweden Sanofi-Aventis Investigational Site Number 752004 Ostersund
Sweden Sanofi-Aventis Investigational Site Number 752001 Stockolm
Taiwan Sanofi-Aventis Investigational Site Number 158003 Kaohsiung
Taiwan Sanofi-Aventis Investigational Site Number 158002 Taichung
Taiwan Sanofi-Aventis Investigational Site Number 158004 Tainan Hsien
Taiwan Sanofi-Aventis Investigational Site Number 158001 Taipei
Taiwan Sanofi-Aventis Investigational Site Number 158005 Taipei
Thailand Sanofi-Aventis Investigational Site Number 764001 Bangkok
Thailand Sanofi-Aventis Investigational Site Number 764002 Bangkok-Noi
Thailand Sanofi-Aventis Investigational Site Number 764003 Muang
Turkey Sanofi-Aventis Investigational Site Number 792004 Edirne
Turkey Sanofi-Aventis Investigational Site Number 792005 Edirne
Turkey Sanofi-Aventis Investigational Site Number 792001 Istanbul
Turkey Sanofi-Aventis Investigational Site Number 792002 Istanbul
Turkey Sanofi-Aventis Investigational Site Number 792003 Istanbul
Turkey Sanofi-Aventis Investigational Site Number 792006 Kocaeli
Turkey Sanofi-Aventis Investigational Site Number 792007 Kocaeli
Ukraine Sanofi-Aventis Investigational Site Number 804013 Dnepropetrovsk
Ukraine Sanofi-Aventis Investigational Site Number 804015 Dnepropetrovsk
Ukraine Sanofi-Aventis Investigational Site Number 804005 Dnipropetrovsk
Ukraine Sanofi-Aventis Investigational Site Number 804008 Ivano-Frankivsk
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Ukraine Sanofi-Aventis Investigational Site Number 804002 Kharkov
Ukraine Sanofi-Aventis Investigational Site Number 804012 Kharkov
Ukraine Sanofi-Aventis Investigational Site Number 804003 Kiev
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Ukraine Sanofi-Aventis Investigational Site Number 804014 Zaporizhzhia
United States Sanofi-Aventis Investigational Site Number 840047 Alexandria Louisiana
United States Sanofi-Aventis Investigational Site Number 840311 Alpena Michigan
United States Sanofi-Aventis Investigational Site Number 840076 Amarillo Texas
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United States Sanofi-Aventis Investigational Site Number 840261 Anderson South Carolina
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United States Sanofi-Aventis Investigational Site Number 840197 Centerville Ohio
United States Sanofi-Aventis Investigational Site Number 840206 Chicago Illinois
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United States Sanofi-Aventis Investigational Site Number 840317 Denton Maryland
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United States Sanofi-Aventis Investigational Site Number 840032 Fort Meade South Dakota
United States Sanofi-Aventis Investigational Site Number 840126 Fremont Nebraska
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United States Sanofi-Aventis Investigational Site Number 840196 Greensboro North Carolina
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United States Sanofi-Aventis Investigational Site Number 840067 Gulfport Mississippi
United States Sanofi-Aventis Investigational Site Number 840303 Hamilton New Jersey
United States Sanofi-Aventis Investigational Site Number 840127 Hickory North Carolina
United States Sanofi-Aventis Investigational Site Number 840131 Hollywood Florida
United States Sanofi-Aventis Investigational Site Number 840161 Hollywood Florida
United States Sanofi-Aventis Investigational Site Number 840286 Houston Texas
United States Sanofi-Aventis Investigational Site Number 840130 Idaho Falls Idaho
United States Sanofi-Aventis Investigational Site Number 840228 Idaho Falls Idaho
United States Sanofi-Aventis Investigational Site Number 840304 Indiana Pennsylvania
United States Sanofi-Aventis Investigational Site Number 840132 Irving Texas
United States Sanofi-Aventis Investigational Site Number 840218 Jena Louisiana
United States Sanofi-Aventis Investigational Site Number 840129 Johnson City Tennessee
United States Sanofi-Aventis Investigational Site Number 840152 Johnson City New York
United States Sanofi-Aventis Investigational Site Number 840234 Key West Florida
United States Sanofi-Aventis Investigational Site Number 840247 Lafayette Louisiana
United States Sanofi-Aventis Investigational Site Number 840158 Lake Charles Louisiana
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United States Sanofi-Aventis Investigational Site Number 840258 Las Vegas Nevada
United States Sanofi-Aventis Investigational Site Number 840265 Lexington Kentucky
United States Sanofi-Aventis Investigational Site Number 840109 Linden New Jersey
United States Sanofi-Aventis Investigational Site Number 840224 Little Rock Arkansas
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United States Sanofi-Aventis Investigational Site Number 840293 Madison Wisconsin
United States Sanofi-Aventis Investigational Site Number 840122 Manning South Carolina
United States Sanofi-Aventis Investigational Site Number 840026 Mason Ohio
United States Sanofi-Aventis Investigational Site Number 840198 Melbourne Florida
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United States Sanofi-Aventis Investigational Site Number 840227 Mobile Alabama
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United States Sanofi-Aventis Investigational Site Number 840179 Mountain Home Arkansas
United States Sanofi-Aventis Investigational Site Number 840143 Nampa Idaho
United States Sanofi-Aventis Investigational Site Number 840269 Nashville Tennessee
United States Sanofi-Aventis Investigational Site Number 840077 Natchitoches Louisiana
United States Sanofi-Aventis Investigational Site Number 840085 Newberry South Carolina
United States Sanofi-Aventis Investigational Site Number 840003 Niceville Florida
United States Sanofi-Aventis Investigational Site Number 840272 Northridge California
United States Sanofi-Aventis Investigational Site Number 840230 Ocala Florida
United States Sanofi-Aventis Investigational Site Number 840005 Odessa Texas
United States Sanofi-Aventis Investigational Site Number 840289 Odessa Texas
United States Sanofi-Aventis Investigational Site Number 840045 Oklahoma City Oklahoma
United States Sanofi-Aventis Investigational Site Number 840213 Orange California
United States Sanofi-Aventis Investigational Site Number 840202 Orlando Florida
United States Sanofi-Aventis Investigational Site Number 840306 Orlando Florida
United States Sanofi-Aventis Investigational Site Number 840022 Ormond Beach Florida
United States Sanofi-Aventis Investigational Site Number 840110 Palm Harbor Florida
United States Sanofi-Aventis Investigational Site Number 840189 Pelzer South Carolina
United States Sanofi-Aventis Investigational Site Number 840128 Philadelphia Pennsylvania
United States Sanofi-Aventis Investigational Site Number 840160 Philadelphia Pennsylvania
United States Sanofi-Aventis Investigational Site Number 840339 Philadelphia Pennsylvania
United States Sanofi-Aventis Investigational Site Number 840006 Picayune Mississippi
United States Sanofi-Aventis Investigational Site Number 840181 Pittsburgh Pennsylvania
United States Sanofi-Aventis Investigational Site Number 840211 Plantation Florida
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United States Sanofi-Aventis Investigational Site Number 840150 Raleigh North Carolina
United States Sanofi-Aventis Investigational Site Number 840009 Redondo Beach California
United States Sanofi-Aventis Investigational Site Number 840298 Riverside California
United States Sanofi-Aventis Investigational Site Number 840159 Rochester New York
United States Sanofi-Aventis Investigational Site Number 840185 Rocky Mount North Carolina
United States Sanofi-Aventis Investigational Site Number 840068 Salem Virginia
United States Sanofi-Aventis Investigational Site Number 840238 Salt Lake City Utah
United States Sanofi-Aventis Investigational Site Number 840308 Salt Lake City Utah
United States Sanofi-Aventis Investigational Site Number 840186 San Antonio Texas
United States Sanofi-Aventis Investigational Site Number 840194 San Antonio Texas
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United States Sanofi-Aventis Investigational Site Number 840116 Sanford Florida
United States Sanofi-Aventis Investigational Site Number 840103 Santa Ana California
United States Sanofi-Aventis Investigational Site Number 840002 Santa Rosa California
United States Sanofi-Aventis Investigational Site Number 840165 Savannah Georgia
United States Sanofi-Aventis Investigational Site Number 840229 Scotland Pennsylvania
United States Sanofi-Aventis Investigational Site Number 840123 Seattle Washington
United States Sanofi-Aventis Investigational Site Number 840231 Shreveport Louisiana
United States Sanofi-Aventis Investigational Site Number 840232 Shreveport Louisiana
United States Sanofi-Aventis Investigational Site Number 840259 Shreveport Louisiana
United States Sanofi-Aventis Investigational Site Number 840243 Spring Hill Florida
United States Sanofi-Aventis Investigational Site Number 840219 Springfield Virginia
United States Sanofi-Aventis Investigational Site Number 840134 St Cloud Minnesota
United States Sanofi-Aventis Investigational Site Number 840201 St Louis Missouri
United States Sanofi-Aventis Investigational Site Number 840137 St. Clair Shores Michigan
United States Sanofi-Aventis Investigational Site Number 840200 St. Louis Missouri
United States Sanofi-Aventis Investigational Site Number 840310 St. Louis Missouri
United States Sanofi-Aventis Investigational Site Number 840323 St. Louis Missouri
United States Sanofi-Aventis Investigational Site Number 840012 St. Petersburg Florida
United States Sanofi-Aventis Investigational Site Number 840082 St. Petersburg Florida
United States Sanofi-Aventis Investigational Site Number 840072 Stoneboro Pennsylvania
United States Sanofi-Aventis Investigational Site Number 840019 Tacoma Washington
United States Sanofi-Aventis Investigational Site Number 840236 Temple Texas
United States Sanofi-Aventis Investigational Site Number 840233 Toledo Ohio
United States Sanofi-Aventis Investigational Site Number 840111 Torrance California
United States Sanofi-Aventis Investigational Site Number 840209 Tucson Arizona
United States Sanofi-Aventis Investigational Site Number 840133 Tulsa Oklahoma
United States Sanofi-Aventis Investigational Site Number 840011 Victoria Texas
United States Sanofi-Aventis Investigational Site Number 840118 Visalia California
United States Sanofi-Aventis Investigational Site Number 840064 Wadsworth Ohio
United States Sanofi-Aventis Investigational Site Number 840282 Wauwatosa Wisconsin
United States Sanofi-Aventis Investigational Site Number 840056 Westfield New York
United States Sanofi-Aventis Investigational Site Number 840249 Wichita Kansas
United States Sanofi-Aventis Investigational Site Number 840285 Wichita Falls Texas
Venezuela Sanofi-Aventis Investigational Site Number 862001 Caracas
Venezuela Sanofi-Aventis Investigational Site Number 862002 Maracay

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Australia,  Austria,  Belarus,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Costa Rica,  Croatia,  Czech Republic,  Denmark,  Egypt,  Estonia,  Finland,  France,  Greece,  Guatemala,  India,  Indonesia,  Israel,  Italy,  Korea, Republic of,  Lithuania,  Malaysia,  Mexico,  Morocco,  Netherlands,  New Zealand,  Norway,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) From randomization up to the end of the treatment period (minimum of 6 months) No
Secondary Components of the primary study outcome measure: From randomization up to the end of the treatment period (minimum of 6 months) No
Secondary Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death From randomization up to the end of the treatment period (minimum of 6 months) No
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