Evaluation of Weekly Subcutaneous Biotinylated Idraparinux Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— BOREALIS-AF  

Official title:

A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

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

• Atrial Fibrillation
• Thromboembolism

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
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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
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France	Sanofi-Aventis Investigational Site Number 250018	Dijon Cedex
France	Sanofi-Aventis Investigational Site Number 250004	La Rochelle
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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
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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
Ukraine	Sanofi-Aventis Investigational Site Number 804004	Kharkiv
Ukraine	Sanofi-Aventis Investigational Site Number 804002	Kharkov
Ukraine	Sanofi-Aventis Investigational Site Number 804012	Kharkov
Ukraine	Sanofi-Aventis Investigational Site Number 804003	Kiev
Ukraine	Sanofi-Aventis Investigational Site Number 804007	Lutsk
Ukraine	Sanofi-Aventis Investigational Site Number 804009	Lutsk
Ukraine	Sanofi-Aventis Investigational Site Number 804011	Odessa
Ukraine	Sanofi-Aventis Investigational Site Number 804010	Ternopil
Ukraine	Sanofi-Aventis Investigational Site Number 804006	Uzhgorod
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
United States	Sanofi-Aventis Investigational Site Number 840096	Anaconda	Montana
United States	Sanofi-Aventis Investigational Site Number 840261	Anderson	South Carolina
United States	Sanofi-Aventis Investigational Site Number 840297	Anderson	South Carolina
United States	Sanofi-Aventis Investigational Site Number 840062	Athens	Tennessee
United States	Sanofi-Aventis Investigational Site Number 840073	Atlanta	Georgia
United States	Sanofi-Aventis Investigational Site Number 840145	Auburn	Maine
United States	Sanofi-Aventis Investigational Site Number 840273	Augusta	Georgia
United States	Sanofi-Aventis Investigational Site Number 840017	Baltimore	Maryland
United States	Sanofi-Aventis Investigational Site Number 840246	Bay Pines	Florida
United States	Sanofi-Aventis Investigational Site Number 840066	Beach	Florida
United States	Sanofi-Aventis Investigational Site Number 840280	Beaver	Indiana
United States	Sanofi-Aventis Investigational Site Number 840256	Beloit	Wisconsin
United States	Sanofi-Aventis Investigational Site Number 840113	Bend	Oregon
United States	Sanofi-Aventis Investigational Site Number 840270	Beverly Hills	California
United States	Sanofi-Aventis Investigational Site Number 840278	Beverly Hills	California
United States	Sanofi-Aventis Investigational Site Number 840313	Brandon	Florida
United States	Sanofi-Aventis Investigational Site Number 840268	Bridgeport	Connecticut
United States	Sanofi-Aventis Investigational Site Number 840276	Brighton	Michigan
United States	Sanofi-Aventis Investigational Site Number 840048	Bristol	Tennessee
United States	Sanofi-Aventis Investigational Site Number 840052	Bristol	Tennessee
United States	Sanofi-Aventis Investigational Site Number 840284	Bronx	New York
United States	Sanofi-Aventis Investigational Site Number 840102	Buffalo	New York
United States	Sanofi-Aventis Investigational Site Number 840241	Burbank	California
United States	Sanofi-Aventis Investigational Site Number 840008	Butte	Montana
United States	Sanofi-Aventis Investigational Site Number 840172	Camden	South Carolina
United States	Sanofi-Aventis Investigational Site Number 840197	Centerville	Ohio
United States	Sanofi-Aventis Investigational Site Number 840206	Chicago	Illinois
United States	Sanofi-Aventis Investigational Site Number 840221	Chicago	Illinois
United States	Sanofi-Aventis Investigational Site Number 840074	Cincinnati	Ohio
United States	Sanofi-Aventis Investigational Site Number 840104	Cleveland	Tennessee
United States	Sanofi-Aventis Investigational Site Number 840146	Cleveland	Ohio
United States	Sanofi-Aventis Investigational Site Number 840223	Clinton	Utah
United States	Sanofi-Aventis Investigational Site Number 840168	Columbia	South Carolina
United States	Sanofi-Aventis Investigational Site Number 840204	Columbus	Georgia
United States	Sanofi-Aventis Investigational Site Number 840225	Columbus	Georgia
United States	Sanofi-Aventis Investigational Site Number 840290	Columbus	Georgia
United States	Sanofi-Aventis Investigational Site Number 840010	Corona	California
United States	Sanofi-Aventis Investigational Site Number 840252	Corsicana	Texas
United States	Sanofi-Aventis Investigational Site Number 840248	Cranston	Rhode Island
United States	Sanofi-Aventis Investigational Site Number 840317	Denton	Maryland
United States	Sanofi-Aventis Investigational Site Number 840242	Detroit	Michigan
United States	Sanofi-Aventis Investigational Site Number 840084	Dunnellon	Florida
United States	Sanofi-Aventis Investigational Site Number 840305	Dunwoody	Georgia
United States	Sanofi-Aventis Investigational Site Number 840014	Elkhart	Indiana
United States	Sanofi-Aventis Investigational Site Number 840195	Encino	California
United States	Sanofi-Aventis Investigational Site Number 840058	Everett	Washington
United States	Sanofi-Aventis Investigational Site Number 840020	Fargo	North Dakota
United States	Sanofi-Aventis Investigational Site Number 840220	Fort Lauderdale	Florida
United States	Sanofi-Aventis Investigational Site Number 840032	Fort Meade	South Dakota
United States	Sanofi-Aventis Investigational Site Number 840126	Fremont	Nebraska
United States	Sanofi-Aventis Investigational Site Number 840138	Ft. Lauderdale	Florida
United States	Sanofi-Aventis Investigational Site Number 840215	Gainesville	Florida
United States	Sanofi-Aventis Investigational Site Number 840292	Gallipolis	Ohio
United States	Sanofi-Aventis Investigational Site Number 840253	Grand Rapids	Michigan
United States	Sanofi-Aventis Investigational Site Number 840196	Greensboro	North Carolina
United States	Sanofi-Aventis Investigational Site Number 840277	Greensboro	North Carolina
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
United States	Sanofi-Aventis Investigational Site Number 840112	Lake Mary	Florida
United States	Sanofi-Aventis Investigational Site Number 840053	Lakeland	Florida
United States	Sanofi-Aventis Investigational Site Number 840051	Las Vegas	Nevada
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
United States	Sanofi-Aventis Investigational Site Number 840255	Little Rock	Arkansas
United States	Sanofi-Aventis Investigational Site Number 840033	Loma Linda	California
United States	Sanofi-Aventis Investigational Site Number 840184	Long Beach	California
United States	Sanofi-Aventis Investigational Site Number 840183	Los Banos	California
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
United States	Sanofi-Aventis Investigational Site Number 840117	Miami	Florida
United States	Sanofi-Aventis Investigational Site Number 840227	Mobile	Alabama
United States	Sanofi-Aventis Investigational Site Number 840024	Morristown	New Jersey
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
United States	Sanofi-Aventis Investigational Site Number 840257	Portland	Oregon
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
United States	Sanofi-Aventis Investigational Site Number 840264	San Diego	California
United States	Sanofi-Aventis Investigational Site Number 840275	San Diego	California
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