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

This study has been terminated.
(early discontinuation based on strategic sponsor decision not driven by any safety concern)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00580216
First received: December 21, 2007
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Drug: Idrabiotaparinux
Drug: Warfarin
Drug: Placebo (for idrabiotaparinux)
Drug: Placebo (for warfarin)
Drug: Avidin
Drug: Placebo (for avidin)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) [ Time Frame: From randomization up to the end of the treatment period (minimum of 6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Components of the primary study outcome measure: [ Time Frame: From randomization up to the end of the treatment period (minimum of 6 months) ] [ Designated as safety issue: No ]
  • Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death [ Time Frame: From randomization up to the end of the treatment period (minimum of 6 months) ] [ Designated as safety issue: No ]

Enrollment: 3773
Study Start Date: December 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idrabiotaparinux

Idrabiotaparinux, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months.

Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).

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

Other Names:
  • SSR126517
  • Biotinylated idraparinux
Drug: Placebo (for warfarin)

Warfarin matching capsules

Oral administration

Drug: Avidin

Vial containing 105 mg of lyophilized powder for dilution

Intravenous infusion for 30 minutes

Other Name: SSR29261
Active Comparator: Warfarin
Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
Drug: Warfarin

Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)

Oral administration

Drug: 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

Drug: Placebo (for avidin)

Vial containing 105 mg of matching lyophilized powder for dissolution

Intravenous infusion for 30 minutes


Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580216

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Locations
United States, Alabama
Sanofi-Aventis Investigational Site Number 840227
Mobile, Alabama, United States, 36608
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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, Colombia
Costa Rica
Sanofi-Aventis Investigational Site Number 188004
San José, Costa Rica
Croatia
Sanofi-Aventis Investigational Site Number 191003
Split, Croatia, 21000
Sanofi-Aventis Investigational Site Number 191001
Zagreb, Croatia, 10000
Sanofi-Aventis Investigational Site Number 191004
Zagreb, Croatia, 10000
Czech Republic
Sanofi-Aventis Investigational Site Number 203005
Chomutov, Czech Republic, 43012
Sanofi-Aventis Investigational Site Number 203003
Jihlava, Czech Republic, 58633
Sanofi-Aventis Investigational Site Number 203009
Ostrava Vitkovice, Czech Republic, 70300
Sanofi-Aventis Investigational Site Number 203001
Pardubice, Czech Republic, 53203
Sanofi-Aventis Investigational Site Number 203011
Plzen - Bory, Czech Republic, 30599
Sanofi-Aventis Investigational Site Number 203002
Praha 2, Czech Republic, 12808
Sanofi-Aventis Investigational Site Number 203004
Praha 4, Czech Republic, 14059
Sanofi-Aventis Investigational Site Number 203010
Praha 6, Czech Republic, 16902
Sanofi-Aventis Investigational Site Number 203006
Prostejov, Czech Republic, 796 04
Sanofi-Aventis Investigational Site Number 203008
Usti Nad Orlici, Czech Republic, 56218
Denmark
Sanofi-Aventis Investigational Site Number 208002
Glostrup, Denmark, 2600
Sanofi-Aventis Investigational Site Number 208001
Hellerup, Denmark, 2900
Sanofi-Aventis Investigational Site Number 208007
Hvidovre, Denmark, 2650
Sanofi-Aventis Investigational Site Number 208003
København S, Denmark, 2300
Sanofi-Aventis Investigational Site Number 208004
Odense, Denmark, 5000
Sanofi-Aventis Investigational Site Number 208006
Roskilde, Denmark, 4000
Sanofi-Aventis Investigational Site Number 208005
Svendborg, Denmark, 5700
Egypt
Sanofi-Aventis Investigational Site Number 818002
Alexandria, Egypt
Sanofi-Aventis Investigational Site Number 818004
Alexandria, Egypt
Sanofi-Aventis Investigational Site Number 818003
Alexandria, Egypt
Sanofi-Aventis Investigational Site Number 818001
Cairo, Egypt
Estonia
Sanofi-Aventis Investigational Site Number 233001
Tallinn, Estonia, 13419
Sanofi-Aventis Investigational Site Number 233003
Tallinn, Estonia, 10138
Sanofi-Aventis Investigational Site Number 233004
Tallinn, Estonia, 13415
Sanofi-Aventis Investigational Site Number 233002
Tartu, Estonia, 50410
Finland
Sanofi-Aventis Investigational Site Number 246001
Helsinki, Finland, 00290
France
Sanofi-Aventis Investigational Site Number 250028
Abbeville, France, 80142
Sanofi-Aventis Investigational Site Number 250012
Albi Cedex 9, France, 81013
Sanofi-Aventis Investigational Site Number 250034
Allauch, France, 13190
Sanofi-Aventis Investigational Site Number 250031
Belfort Cedex, France, 90016
Sanofi-Aventis Investigational Site Number 250011
Bordeaux, France, 33076
Sanofi-Aventis Investigational Site Number 250021
Brest, France, 29609
Sanofi-Aventis Investigational Site Number 250010
Brest Cedex 2, France, 29609
Sanofi-Aventis Investigational Site Number 250035
Bron, France, 69677
Sanofi-Aventis Investigational Site Number 250022
Cholet Cedex, France, 49300
Sanofi-Aventis Investigational Site Number 250006
Dijon, France, 21033
Sanofi-Aventis Investigational Site Number 250018
Dijon Cedex, France, 21034
Sanofi-Aventis Investigational Site Number 250004
La Rochelle, France, 17019
Sanofi-Aventis Investigational Site Number 250029
Le Chesnay Cedex, France, 78187
Sanofi-Aventis Investigational Site Number 250015
Lille, France, 59037
Sanofi-Aventis Investigational Site Number 250019
Lille, France, 59020
Sanofi-Aventis Investigational Site Number 250030
Metz Tessy, France, 74370
Sanofi-Aventis Investigational Site Number 250003
Montpellier, France, 34295
Sanofi-Aventis Investigational Site Number 250032
Montpellier, France, 59523
Sanofi-Aventis Investigational Site Number 250016
Nice Cedex, France, 06006
Sanofi-Aventis Investigational Site Number 250001
Paris, France, 75018
Sanofi-Aventis Investigational Site Number 250014
Paris Cedex 13, France, 75651
Sanofi-Aventis Investigational Site Number 250008
Paris Cedex 14, France, 75674
Sanofi-Aventis Investigational Site Number 250005
Saint Etienne Cedex 2, France, 42055
Sanofi-Aventis Investigational Site Number 250026
Toulouse Cedex 9, France, 31059
Sanofi-Aventis Investigational Site Number 250027
Tours Cedex 1, France, 37044
Sanofi-Aventis Investigational Site Number 250002
Vandoeuvre Les Nancy Cedex, France, 54511
Greece
Sanofi-Aventis Investigational Site Number 300002
Athens, Greece, 11538
Sanofi-Aventis Investigational Site Number 300005
Athens, Greece
Sanofi-Aventis Investigational Site Number 300009
Athens, Greece, 11521
Sanofi-Aventis Investigational Site Number 300007
Athens, Greece, 11527
Sanofi-Aventis Investigational Site Number 300006
Chalkida, Greece, 34 100
Sanofi-Aventis Investigational Site Number 300004
Chios, Greece
Sanofi-Aventis Investigational Site Number 300008
Elefsina, Greece, 19600
Guatemala
Sanofi-Aventis Investigational Site Number 320001
Guatemala, Guatemala, 01014
Sanofi-Aventis Investigational Site Number 320002
Guatemala, Guatemala, 01010
Sanofi-Aventis Investigational Site Number 320003
Guatemala, Guatemala, 01014
Sanofi-Aventis Investigational Site Number 320004
Guatemala, Guatemala
India
Sanofi-Aventis Investigational Site Number 356001
Ahmedabad, India, 380 015
Sanofi-Aventis Investigational Site Number 356010
Ahmedabad, India, 380054
Sanofi-Aventis Investigational Site Number 356009
Bangalore, India, 562 150
Sanofi-Aventis Investigational Site Number 356015
Bangalore, India, 560034
Sanofi-Aventis Investigational Site Number 356005
Chennai, India, 600 037
Sanofi-Aventis Investigational Site Number 356007
Coimbatore, India, 641014
Sanofi-Aventis Investigational Site Number 356002
Coimbatore, India, 641004
Sanofi-Aventis Investigational Site Number 356006
Lucknow, India, 226014
Sanofi-Aventis Investigational Site Number 356013
Lucknow, India, 226003
Sanofi-Aventis Investigational Site Number 356017
Mumbai, India, 54
Sanofi-Aventis Investigational Site Number 356014
Mysore, India, 570020
Sanofi-Aventis Investigational Site Number 356020
Nashik, India, 42003
Sanofi-Aventis Investigational Site Number 356012
New Delhi, India
Sanofi-Aventis Investigational Site Number 356004
New Delhi, India, 110060
Sanofi-Aventis Investigational Site Number 356011
Pune, India, 411004
Sanofi-Aventis Investigational Site Number 356018
Pune., India, 400011
Sanofi-Aventis Investigational Site Number 356003
Secunderabad, India, 500 003
Indonesia
Sanofi-Aventis Investigational Site Number 360001
Jakarta, Indonesia
Sanofi-Aventis Investigational Site Number 360002
Jakarta, Indonesia, 10430
Israel
Sanofi-Aventis Investigational Site Number 376003
Afula, Israel, 18101
Sanofi-Aventis Investigational Site Number 376015
Ashkelon, Israel, 78278
Sanofi-Aventis Investigational Site Number 376001
Givatayim, Israel, 53583
Sanofi-Aventis Investigational Site Number 376007
Haifa, Israel, 31048
Sanofi-Aventis Investigational Site Number 376014
Haifa, Israel, 31096
Sanofi-Aventis Investigational Site Number 376004
Holon, Israel, 58100
Sanofi-Aventis Investigational Site Number 376012
Nahariya, Israel, 22100
Sanofi-Aventis Investigational Site Number 376009
Nazareth, Israel, 16100
Sanofi-Aventis Investigational Site Number 376011
Rehovot, Israel, 76100
Sanofi-Aventis Investigational Site Number 376002
Tel Aviv, Israel, 64239
Italy
Sanofi-Aventis Investigational Site Number 380015
Ascoli Piceno, Italy, 63100
Sanofi-Aventis Investigational Site Number 380018
Borgo San Lorenzo, Italy, 50032
Sanofi-Aventis Investigational Site Number 380016
Chieti, Italy, 66013
Sanofi-Aventis Investigational Site Number 380005
Fidenza, Italy, 43036
Sanofi-Aventis Investigational Site Number 380010
Merate, Italy, 23807
Sanofi-Aventis Investigational Site Number 380014
Milano, Italy, 20132
Sanofi-Aventis Investigational Site Number 380020
Novara, Italy, 28100
Sanofi-Aventis Investigational Site Number 380007
Padova, Italy, 35128
Sanofi-Aventis Investigational Site Number 380001
Padova, Italy, 35128
Sanofi-Aventis Investigational Site Number 380004
Palermo, Italy, 90127
Sanofi-Aventis Investigational Site Number 380008
Pavia, Italy, 27100
Sanofi-Aventis Investigational Site Number 380021
Perugia, Italy, 06132
Sanofi-Aventis Investigational Site Number 380013
San Daniele Del Friuli, Italy, 33038
Sanofi-Aventis Investigational Site Number 380003
Sassari, Italy, 07100
Sanofi-Aventis Investigational Site Number 380011
Torino, Italy, 10144
Sanofi-Aventis Investigational Site Number 380009
Treviso, Italy, 31100
Korea, Republic of
Sanofi-Aventis Investigational Site Number 410008
Anyang, Korea, Republic of, 431-070
Sanofi-Aventis Investigational Site Number 410002
Daegu, Korea, Republic of, 700-712
Sanofi-Aventis Investigational Site Number 410006
Goyang, Korea, Republic of, 411-706
Sanofi-Aventis Investigational Site Number 410012
Goyang, Korea, Republic of, 411-773
Sanofi-Aventis Investigational Site Number 410007
Gwangju, Korea, Republic of, 501-757
Sanofi-Aventis Investigational Site Number 410003
Seongnam, Korea, Republic of, 463-802
Sanofi-Aventis Investigational Site Number 410001
Seoul, Korea, Republic of, 134-701
Sanofi-Aventis Investigational Site Number 410004
Seoul, Korea, Republic of, 135-710
Sanofi-Aventis Investigational Site Number 410005
Seoul, Korea, Republic of, 138-736
Sanofi-Aventis Investigational Site Number 410011
Seoul, Korea, Republic of, 140-210
Lithuania
Sanofi-Aventis Investigational Site Number 440002
Kaunas, Lithuania, LT-49456
Sanofi-Aventis Investigational Site Number 440004
Kaunas, Lithuania, 3007
Sanofi-Aventis Investigational Site Number 440001
Vilnius, Lithuania, LT-08661
Sanofi-Aventis Investigational Site Number 440003
Vilnius, Lithuania, LT-07156
Malaysia
Sanofi-Aventis Investigational Site Number 458001
Kuching, Malaysia, 93586
Sanofi-Aventis Investigational Site Number 458002
Penang, Malaysia, 10450
Sanofi-Aventis Investigational Site Number 458005
Taiping, Malaysia, 34000
Mexico
Sanofi-Aventis Investigational Site Number 484008
Acapulco, Mexico, 39670
Sanofi-Aventis Investigational Site Number 484013
Aguascalientes, Mexico, 20230
Sanofi-Aventis Investigational Site Number 484016
Aguascalientes, Mexico, 20230
Sanofi-Aventis Investigational Site Number 484004
Guadalajara, Mexico, 4428
Sanofi-Aventis Investigational Site Number 484007
Guadalajara, Mexico, 44340
Sanofi-Aventis Investigational Site Number 484012
Mexico Df, Mexico, 07300
Sanofi-Aventis Investigational Site Number 484010
Monterrey, Mexico, 64060
Sanofi-Aventis Investigational Site Number 484005
San Luis Potosi, Mexico, 78200
Sanofi-Aventis Investigational Site Number 484011
San Luis Potosi, Mexico, 72244
Sanofi-Aventis Investigational Site Number 484003
Veracruz, Mexico, 91700
Morocco
Sanofi-Aventis Investigational Site Number 504001
Marrakech, Morocco, 40000
Sanofi-Aventis Investigational Site Number 504002
Meknes, Morocco, 50000
Netherlands
Sanofi-Aventis Investigational Site Number 528012
Almelo, Netherlands, 7609 PP
Sanofi-Aventis Investigational Site Number 528030
Amsterdam, Netherlands, 1066 EC
Sanofi-Aventis Investigational Site Number 528026
Breda, Netherlands, 4818 CK
Sanofi-Aventis Investigational Site Number 528009
Delft, Netherlands, 2526 AD
Sanofi-Aventis Investigational Site Number 528035
Den Haag, Netherlands, 2545 CH
Sanofi-Aventis Investigational Site Number 528027
Ede, Netherlands, 6716 RP
Sanofi-Aventis Investigational Site Number 528006
Eindhoven, Netherlands, 5623 EJ
Sanofi-Aventis Investigational Site Number 528017
Eindhoven, Netherlands, 5623 EJ
Sanofi-Aventis Investigational Site Number 528016
Gouda, Netherlands, 2803 HH
Sanofi-Aventis Investigational Site Number 528007
Harderwijk, Netherlands, 3844 DG
Sanofi-Aventis Investigational Site Number 528001
Heerlen, Netherlands, 6419 PC
Sanofi-Aventis Investigational Site Number 528024
Heerlen, Netherlands, 6419 PC
Sanofi-Aventis Investigational Site Number 528003
Hengelo, Netherlands, 7555 DL
Sanofi-Aventis Investigational Site Number 528010
Hengelo, Netherlands, 7555 DL
Sanofi-Aventis Investigational Site Number 528031
Hoogeveen, Netherlands, 7909 AA
Sanofi-Aventis Investigational Site Number 528019
Hoorn, Netherlands, 1625 HV
Sanofi-Aventis Investigational Site Number 528020
Leeuwarden, Netherlands, 8934 AD
Sanofi-Aventis Investigational Site Number 528004
Nijmegen, Netherlands, 6532 SZ
Sanofi-Aventis Investigational Site Number 528013
Rotterdam, Netherlands, 3083 AN
Sanofi-Aventis Investigational Site Number 528022
Sittard-Geleen, Netherlands, 6162 BG
Sanofi-Aventis Investigational Site Number 528002
Sneek, Netherlands, 8601 ZK
Sanofi-Aventis Investigational Site Number 528033
Tilburg, Netherlands, 5022 GC
Sanofi-Aventis Investigational Site Number 528021
Venlo, Netherlands, 5912 BL
Sanofi-Aventis Investigational Site Number 528005
Zoetermeer, Netherlands, 2725 NA
Sanofi-Aventis Investigational Site Number 528025
Zwolle, Netherlands, 8011 JW
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, New Zealand
Norway
Sanofi-Aventis Investigational Site Number 578001
Bergen, Norway, 5021
Sanofi-Aventis Investigational Site Number 578006
Flekkefjord, Norway, 4400
Sanofi-Aventis Investigational Site Number 578005
Lørenskog, Norway, 1478
Sanofi-Aventis Investigational Site Number 578004
Oslo, Norway, 0027
Panama
Sanofi-Aventis Investigational Site Number 591001
Panama, Panama
Sanofi-Aventis Investigational Site Number 591002
Panama, Panama
Sanofi-Aventis Investigational Site Number 591003
Panama, Panama
Peru
Sanofi-Aventis Investigational Site Number 604001
Lima, Peru, LIMA 13
Sanofi-Aventis Investigational Site Number 604002
Lima, Peru, Lima 11
Sanofi-Aventis Investigational Site Number 604003
Lima, Peru, LIMA 41
Sanofi-Aventis Investigational Site Number 604004
Lima, Peru, CALLAO 2
Sanofi-Aventis Investigational Site Number 604005
Lima, Peru, LIMA 31
Philippines
Sanofi-Aventis Investigational Site Number 608001
Quezon City, Philippines, 1102
Poland
Sanofi-Aventis Investigational Site Number 616013
Chojnice, Poland, 89-600
Sanofi-Aventis Investigational Site Number 616011
Gdansk, Poland, 81-756
Sanofi-Aventis Investigational Site Number 616014
Gdynia-Redlowo, Poland, 81-402
Sanofi-Aventis Investigational Site Number 616009
Katowice, Poland, 40-635
Sanofi-Aventis Investigational Site Number 616017
Lodz, Poland, 91-425
Sanofi-Aventis Investigational Site Number 616002
Lublin, Poland, 20-954
Sanofi-Aventis Investigational Site Number 616012
Ostrowiec Swietokrzyski, Poland, 27-400
Sanofi-Aventis Investigational Site Number 616015
Pulawy, Poland, 24-100
Sanofi-Aventis Investigational Site Number 616007
Torun, Poland, 87-100
Sanofi-Aventis Investigational Site Number 616006
Tychy, Poland, 43-100
Sanofi-Aventis Investigational Site Number 616001
Warszawa, Poland, 02-005
Sanofi-Aventis Investigational Site Number 616010
Warszawa, Poland, 02-097
Sanofi-Aventis Investigational Site Number 616008
Wroclaw, Poland, 50-349
Portugal
Sanofi-Aventis Investigational Site Number 620002
Amadora, Portugal, 2720-276
Sanofi-Aventis Investigational Site Number 620007
Braga, Portugal, 4701-968
Sanofi-Aventis Investigational Site Number 620006
Coimbra, Portugal, 3000-075
Sanofi-Aventis Investigational Site Number 620008
Setubal, Portugal, 2910-446
Puerto Rico
Sanofi-Aventis Investigational Site Number 630001
San Juan, Puerto Rico, 00921-3201
Russian Federation
Sanofi-Aventis Investigational Site Number 643033
Barnaul, Russian Federation, 656055
Sanofi-Aventis Investigational Site Number 643036
Chelyabinsk, Russian Federation, 454136
Sanofi-Aventis Investigational Site Number 643040
Chelyabinsk, Russian Federation, 454048
Sanofi-Aventis Investigational Site Number 643050
Chelyabinsk, Russian Federation, 454092
Sanofi-Aventis Investigational Site Number 643031
Ekaterinburg, Russian Federation, 620109
Sanofi-Aventis Investigational Site Number 643009
Kemerovo, Russian Federation, 650002
Sanofi-Aventis Investigational Site Number 643042
Kemerovo, Russian Federation, 650002
Sanofi-Aventis Investigational Site Number 643007
Moscow, Russian Federation, 111539
Sanofi-Aventis Investigational Site Number 643001
Moscow, Russian Federation, 121552
Sanofi-Aventis Investigational Site Number 643011
Moscow, Russian Federation, 127473
Sanofi-Aventis Investigational Site Number 643015
Moscow, Russian Federation, 105066
Sanofi-Aventis Investigational Site Number 643020
Moscow, Russian Federation, 117292
Sanofi-Aventis Investigational Site Number 643025
Moscow, Russian Federation, 119435
Sanofi-Aventis Investigational Site Number 643026
Moscow, Russian Federation, 121552
Sanofi-Aventis Investigational Site Number 643028
Moscow, Russian Federation, 121359
Sanofi-Aventis Investigational Site Number 643030
Moscow, Russian Federation, 129336
Sanofi-Aventis Investigational Site Number 643032
Moscow, Russian Federation, 109263
Sanofi-Aventis Investigational Site Number 643034
Moscow, Russian Federation, 127473
Sanofi-Aventis Investigational Site Number 643039
Moscow, Russian Federation, 121552
Sanofi-Aventis Investigational Site Number 643037
Moscow, Russian Federation, 121359
Sanofi-Aventis Investigational Site Number 643049
Moscow, Russian Federation, 129090
Sanofi-Aventis Investigational Site Number 643052
Moscow, Russian Federation, 117556
Sanofi-Aventis Investigational Site Number 643056
Moscow, Russian Federation, 119415
Sanofi-Aventis Investigational Site Number 643054
Moscow, Russian Federation, 117342
Sanofi-Aventis Investigational Site Number 643053
Moscow, Russian Federation, 119435
Sanofi-Aventis Investigational Site Number 643013
Nizhny Novgorod, Russian Federation, 603003
Sanofi-Aventis Investigational Site Number 643041
Nizniy Novgorod, Russian Federation, 603005
Sanofi-Aventis Investigational Site Number 643044
Novosibirsk, Russian Federation, 630091
Sanofi-Aventis Investigational Site Number 643051
Novosibirsk, Russian Federation, 630008
Sanofi-Aventis Investigational Site Number 643048
Novosibirsk-117, Russian Federation, 630117
Sanofi-Aventis Investigational Site Number 643045
Penza, Russian Federation
Sanofi-Aventis Investigational Site Number 643006
Perm, Russian Federation, 614107
Sanofi-Aventis Investigational Site Number 643023
Perm, Russian Federation, 614097
Sanofi-Aventis Investigational Site Number 643046
Petrozavodsk, Russian Federation, 185019
Sanofi-Aventis Investigational Site Number 643012
Rostov-Na-Donu, Russian Federation, 344068
Sanofi-Aventis Investigational Site Number 643008
Ryazan, Russian Federation, 390026
Sanofi-Aventis Investigational Site Number 643017
Saint-Petersburg, Russian Federation, 197022
Sanofi-Aventis Investigational Site Number 643047
Saint-Petersburg, Russian Federation, 197022
Sanofi-Aventis Investigational Site Number 643029
Samara, Russian Federation, 443070
Sanofi-Aventis Investigational Site Number 643003
Saratov, Russian Federation, 410054
Sanofi-Aventis Investigational Site Number 643005
Saratov, Russian Federation, 410028
Sanofi-Aventis Investigational Site Number 643004
Saratov, Russian Federation, 410028
Sanofi-Aventis Investigational Site Number 643002
St-Petersburg, Russian Federation, 199106
Sanofi-Aventis Investigational Site Number 643010
St-Petersburg, Russian Federation, 198013
Sanofi-Aventis Investigational Site Number 643016
St-Petersburg, Russian Federation, 196247
Sanofi-Aventis Investigational Site Number 643018
St-Petersburg, Russian Federation, 197110
Sanofi-Aventis Investigational Site Number 643022
St-Petersburg, Russian Federation, 192242
Sanofi-Aventis Investigational Site Number 643027
St-Petersburg, Russian Federation, 198013
Sanofi-Aventis Investigational Site Number 643038
St-Petersburg, Russian Federation, 194354
Sanofi-Aventis Investigational Site Number 643024
Tomsk, Russian Federation, 634012
Sanofi-Aventis Investigational Site Number 643035
Tomsk, Russian Federation, 634012
Sanofi-Aventis Investigational Site Number 643021
Tyumen, Russian Federation, 625023
Sanofi-Aventis Investigational Site Number 643043
Voronezh, Russian Federation, 394006
Sanofi-Aventis Investigational Site Number 643019
Yaroslavl, Russian Federation, 150062
Slovakia
Sanofi-Aventis Investigational Site Number 703003
Kosice, Slovakia, 04015
Sanofi-Aventis Investigational Site Number 703005
Levice, Slovakia
Sanofi-Aventis Investigational Site Number 703004
Nitra, Slovakia, 950 01
Sanofi-Aventis Investigational Site Number 703006
Poprad, Slovakia, 05845
Sanofi-Aventis Investigational Site Number 703002
Trnava, Slovakia, 91775
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, 7129
Sanofi-Aventis Investigational Site Number 710017
Cape Town, South Africa, 7764
Sanofi-Aventis Investigational Site Number 710001
Durban, South Africa, 4092
Sanofi-Aventis Investigational Site Number 710012
Durban, South Africa
Sanofi-Aventis Investigational Site Number 710009
Johannesburg, South Africa, 1449
Sanofi-Aventis Investigational Site Number 710016
Port Elizabeth, South Africa
Sanofi-Aventis Investigational Site Number 710003
Pretoria, South Africa, 0084
Sanofi-Aventis Investigational Site Number 710002
Pretoria, South Africa, 0204
Sanofi-Aventis Investigational Site Number 710020
Pretoria, South Africa, 0050
Sanofi-Aventis Investigational Site Number 710015
Randburg, South Africa, 2194
Sanofi-Aventis Investigational Site Number 710014
Scottburgh, South Africa
Sanofi-Aventis Investigational Site Number 710018
Umhlanga Rocks, South Africa, 4400
Spain
Sanofi-Aventis Investigational Site Number 724002
Barcelona, Spain, 08036
Sanofi-Aventis Investigational Site Number 724003
Barcelona, Spain, 08003
Sanofi-Aventis Investigational Site Number 724001
Madrid, Spain, 28046
Sanofi-Aventis Investigational Site Number 724005
Santiago De Compostela, Spain, 15706
Sanofi-Aventis Investigational Site Number 724007
Sevilla, Spain, 41006
Sweden
Sanofi-Aventis Investigational Site Number 752003
Göteborg, Sweden, 413 45
Sanofi-Aventis Investigational Site Number 752006
Göteborg, Sweden, 413 45
Sanofi-Aventis Investigational Site Number 752007
Malmo, Sweden, 211 52
Sanofi-Aventis Investigational Site Number 752002
Malmö, Sweden, 20502
Sanofi-Aventis Investigational Site Number 752004
Ostersund, Sweden, 831 83
Sanofi-Aventis Investigational Site Number 752001
Stockolm, Sweden, SE-171 76
Taiwan
Sanofi-Aventis Investigational Site Number 158003
Kaohsiung, Taiwan, 833
Sanofi-Aventis Investigational Site Number 158002
Taichung, Taiwan
Sanofi-Aventis Investigational Site Number 158004
Tainan Hsien, Taiwan, 710
Sanofi-Aventis Investigational Site Number 158001
Taipei, Taiwan
Sanofi-Aventis Investigational Site Number 158005
Taipei, Taiwan
Thailand
Sanofi-Aventis Investigational Site Number 764001
Bangkok, Thailand, 10330
Sanofi-Aventis Investigational Site Number 764002
Bangkok-Noi, Thailand, 10700
Sanofi-Aventis Investigational Site Number 764003
Muang, Thailand, 50200
Turkey
Sanofi-Aventis Investigational Site Number 792004
Edirne, Turkey
Sanofi-Aventis Investigational Site Number 792005
Edirne, Turkey
Sanofi-Aventis Investigational Site Number 792002
Istanbul, Turkey, 34034
Sanofi-Aventis Investigational Site Number 792001
Istanbul, Turkey
Sanofi-Aventis Investigational Site Number 792003
Istanbul, Turkey
Sanofi-Aventis Investigational Site Number 792006
Kocaeli, Turkey, 41300
Sanofi-Aventis Investigational Site Number 792007
Kocaeli, Turkey, 41380
Ukraine
Sanofi-Aventis Investigational Site Number 804015
Dnepropetrovsk, Ukraine
Sanofi-Aventis Investigational Site Number 804013
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 804009
Lutsk, Ukraine
Sanofi-Aventis Investigational Site Number 804007
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, Ukraine
Venezuela
Sanofi-Aventis Investigational Site Number 862001
Caracas, Venezuela
Sanofi-Aventis Investigational Site Number 862002
Maracay, Venezuela, 2103
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00580216     History of Changes
Other Study ID Numbers: EFC10295, 2007-004817-33
Study First Received: December 21, 2007
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration
Russia: Pharmacological Committee, Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Sanofi:
stroke
systemic thromboembolic events

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Thromboembolism
Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Embolism and Thrombosis
Thrombosis
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014