The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00580216




Registration number
NCT00580216
Ethics application status
Date submitted
21/12/2007
Date registered
24/12/2007
Date last updated
21/03/2016

Titles & IDs
Public title
Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
Scientific 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
Secondary ID [1] 0 0
2007-004817-33
Secondary ID [2] 0 0
EFC10295
Universal Trial Number (UTN)
Trial acronym
BOREALIS-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Idrabiotaparinux sodium
Treatment: Drugs - Warfarin
Treatment: Drugs - Placebo (for idrabiotaparinux)
Treatment: Drugs - Placebo (for warfarin)
Treatment: Drugs - Avidin
Treatment: Drugs - Placebo (for avidin)

Experimental: Idrabiotaparinux - Idrabiotaparinux sodium, 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).

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


Treatment: Drugs: Idrabiotaparinux sodium
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

Treatment: Drugs: Warfarin
Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)
Oral administration

Treatment: Drugs: 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

Treatment: Drugs: Placebo (for warfarin)
Warfarin matching capsules
Oral administration

Treatment: Drugs: Avidin
Vial containing 105 mg of lyophilized powder for dilution
Intravenous infusion for 30 minutes

Treatment: Drugs: Placebo (for avidin)
Vial containing 105 mg of matching lyophilized powder for dissolution
Intravenous infusion for 30 minutes

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE)
Timepoint [1] 0 0
From randomization up to the end of the treatment period (minimum of 6 months)
Secondary outcome [1] 0 0
Components of the primary study outcome measure:
Timepoint [1] 0 0
From randomization up to the end of the treatment period (minimum of 6 months)
Secondary outcome [2] 0 0
Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death
Timepoint [2] 0 0
From randomization up to the end of the treatment period (minimum of 6 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Investigational Site Number 036006 - Adelaide
Recruitment hospital [2] 0 0
Sanofi-Aventis Investigational Site Number 036003 - Auchenflower
Recruitment hospital [3] 0 0
Sanofi-Aventis Investigational Site Number 036008 - Box Hill
Recruitment hospital [4] 0 0
Sanofi-Aventis Investigational Site Number 036005 - Coffs Harbour
Recruitment hospital [5] 0 0
Sanofi-Aventis Investigational Site Number 036001 - Kippa Ring
Recruitment hospital [6] 0 0
Sanofi-Aventis Investigational Site Number 036002 - Kippa Ring
Recruitment hospital [7] 0 0
Sanofi-Aventis Investigational Site Number 036009 - Launceston
Recruitment hospital [8] 0 0
Sanofi-Aventis Investigational Site Number 036010 - Woden
Recruitment postcode(s) [1] 0 0
5035 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [6] 0 0
7250 - Launceston
Recruitment postcode(s) [7] 0 0
2606 - Woden
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Montana
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
North Dakota
Country [27] 0 0
United States of America
State/province [27] 0 0
Ohio
Country [28] 0 0
United States of America
State/province [28] 0 0
Oklahoma
Country [29] 0 0
United States of America
State/province [29] 0 0
Oregon
Country [30] 0 0
United States of America
State/province [30] 0 0
Pennsylvania
Country [31] 0 0
United States of America
State/province [31] 0 0
Rhode Island
Country [32] 0 0
United States of America
State/province [32] 0 0
South Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
South Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Tennessee
Country [35] 0 0
United States of America
State/province [35] 0 0
Texas
Country [36] 0 0
United States of America
State/province [36] 0 0
Utah
Country [37] 0 0
United States of America
State/province [37] 0 0
Virginia
Country [38] 0 0
United States of America
State/province [38] 0 0
Washington
Country [39] 0 0
United States of America
State/province [39] 0 0
Wisconsin
Country [40] 0 0
Argentina
State/province [40] 0 0
Buenos Aires
Country [41] 0 0
Argentina
State/province [41] 0 0
Capital Federal
Country [42] 0 0
Argentina
State/province [42] 0 0
Corrientes
Country [43] 0 0
Argentina
State/province [43] 0 0
Mar Del Plata
Country [44] 0 0
Argentina
State/province [44] 0 0
Moron
Country [45] 0 0
Argentina
State/province [45] 0 0
Salta
Country [46] 0 0
Argentina
State/province [46] 0 0
Zarate
Country [47] 0 0
Austria
State/province [47] 0 0
Graz
Country [48] 0 0
Austria
State/province [48] 0 0
Linz
Country [49] 0 0
Belarus
State/province [49] 0 0
Minsk
Country [50] 0 0
Brazil
State/province [50] 0 0
Belo Horizonte
Country [51] 0 0
Brazil
State/province [51] 0 0
Campina Grande Do Sul
Country [52] 0 0
Brazil
State/province [52] 0 0
Campinas
Country [53] 0 0
Brazil
State/province [53] 0 0
Curitiba
Country [54] 0 0
Brazil
State/province [54] 0 0
Goiania
Country [55] 0 0
Brazil
State/province [55] 0 0
Maceio
Country [56] 0 0
Brazil
State/province [56] 0 0
Porto Alegre
Country [57] 0 0
Brazil
State/province [57] 0 0
Recife
Country [58] 0 0
Brazil
State/province [58] 0 0
Sao Jose Do Rio Preto
Country [59] 0 0
Brazil
State/province [59] 0 0
Sao Paulo
Country [60] 0 0
Brazil
State/province [60] 0 0
Uberlandia
Country [61] 0 0
Bulgaria
State/province [61] 0 0
Pleven
Country [62] 0 0
Bulgaria
State/province [62] 0 0
Plovdiv
Country [63] 0 0
Bulgaria
State/province [63] 0 0
Sofia
Country [64] 0 0
Canada
State/province [64] 0 0
London
Country [65] 0 0
Canada
State/province [65] 0 0
Newmarket
Country [66] 0 0
Canada
State/province [66] 0 0
Quebec
Country [67] 0 0
Canada
State/province [67] 0 0
Toronto
Country [68] 0 0
Chile
State/province [68] 0 0
Santiago
Country [69] 0 0
Chile
State/province [69] 0 0
Viña Del Mar
Country [70] 0 0
Colombia
State/province [70] 0 0
Bogota
Country [71] 0 0
Colombia
State/province [71] 0 0
Bucaramanga
Country [72] 0 0
Colombia
State/province [72] 0 0
Envigado-Antioquia
Country [73] 0 0
Colombia
State/province [73] 0 0
Medellin
Country [74] 0 0
Costa Rica
State/province [74] 0 0
San José
Country [75] 0 0
Croatia
State/province [75] 0 0
Split
Country [76] 0 0
Croatia
State/province [76] 0 0
Zagreb
Country [77] 0 0
Czech Republic
State/province [77] 0 0
Chomutov
Country [78] 0 0
Czech Republic
State/province [78] 0 0
Jihlava
Country [79] 0 0
Czech Republic
State/province [79] 0 0
Ostrava Vitkovice
Country [80] 0 0
Czech Republic
State/province [80] 0 0
Pardubice
Country [81] 0 0
Czech Republic
State/province [81] 0 0
Plzen - Bory
Country [82] 0 0
Czech Republic
State/province [82] 0 0
Praha 2
Country [83] 0 0
Czech Republic
State/province [83] 0 0
Praha 4
Country [84] 0 0
Czech Republic
State/province [84] 0 0
Praha 6
Country [85] 0 0
Czech Republic
State/province [85] 0 0
Prostejov
Country [86] 0 0
Czech Republic
State/province [86] 0 0
Usti Nad Orlici
Country [87] 0 0
Denmark
State/province [87] 0 0
Glostrup
Country [88] 0 0
Denmark
State/province [88] 0 0
Hellerup
Country [89] 0 0
Denmark
State/province [89] 0 0
Hvidovre
Country [90] 0 0
Denmark
State/province [90] 0 0
København S
Country [91] 0 0
Denmark
State/province [91] 0 0
Odense
Country [92] 0 0
Denmark
State/province [92] 0 0
Roskilde
Country [93] 0 0
Denmark
State/province [93] 0 0
Svendborg
Country [94] 0 0
Egypt
State/province [94] 0 0
Alexandria
Country [95] 0 0
Egypt
State/province [95] 0 0
Cairo
Country [96] 0 0
Estonia
State/province [96] 0 0
Tallinn
Country [97] 0 0
Estonia
State/province [97] 0 0
Tartu
Country [98] 0 0
Finland
State/province [98] 0 0
Helsinki
Country [99] 0 0
France
State/province [99] 0 0
Abbeville
Country [100] 0 0
France
State/province [100] 0 0
Albi Cedex 9
Country [101] 0 0
France
State/province [101] 0 0
Allauch
Country [102] 0 0
France
State/province [102] 0 0
Belfort Cedex
Country [103] 0 0
France
State/province [103] 0 0
Bordeaux
Country [104] 0 0
France
State/province [104] 0 0
Brest Cedex 2
Country [105] 0 0
France
State/province [105] 0 0
Brest
Country [106] 0 0
France
State/province [106] 0 0
Bron
Country [107] 0 0
France
State/province [107] 0 0
Cholet Cedex
Country [108] 0 0
France
State/province [108] 0 0
Dijon Cedex
Country [109] 0 0
France
State/province [109] 0 0
Dijon
Country [110] 0 0
France
State/province [110] 0 0
La Rochelle
Country [111] 0 0
France
State/province [111] 0 0
Le Chesnay Cedex
Country [112] 0 0
France
State/province [112] 0 0
Lille
Country [113] 0 0
France
State/province [113] 0 0
Metz Tessy
Country [114] 0 0
France
State/province [114] 0 0
Montpellier
Country [115] 0 0
France
State/province [115] 0 0
Nice Cedex
Country [116] 0 0
France
State/province [116] 0 0
Paris Cedex 13
Country [117] 0 0
France
State/province [117] 0 0
Paris Cedex 14
Country [118] 0 0
France
State/province [118] 0 0
Paris
Country [119] 0 0
France
State/province [119] 0 0
Saint Etienne Cedex 2
Country [120] 0 0
France
State/province [120] 0 0
Toulouse Cedex 9
Country [121] 0 0
France
State/province [121] 0 0
Tours Cedex 1
Country [122] 0 0
France
State/province [122] 0 0
Vandoeuvre Les Nancy Cedex
Country [123] 0 0
Greece
State/province [123] 0 0
Athens
Country [124] 0 0
Greece
State/province [124] 0 0
Chalkida
Country [125] 0 0
Greece
State/province [125] 0 0
Chios
Country [126] 0 0
Greece
State/province [126] 0 0
Elefsina
Country [127] 0 0
Guatemala
State/province [127] 0 0
Guatemala
Country [128] 0 0
India
State/province [128] 0 0
Ahmedabad
Country [129] 0 0
India
State/province [129] 0 0
Bangalore
Country [130] 0 0
India
State/province [130] 0 0
Chennai
Country [131] 0 0
India
State/province [131] 0 0
Coimbatore
Country [132] 0 0
India
State/province [132] 0 0
Lucknow
Country [133] 0 0
India
State/province [133] 0 0
Mumbai
Country [134] 0 0
India
State/province [134] 0 0
Mysore
Country [135] 0 0
India
State/province [135] 0 0
Nashik
Country [136] 0 0
India
State/province [136] 0 0
New Delhi
Country [137] 0 0
India
State/province [137] 0 0
Pune.
Country [138] 0 0
India
State/province [138] 0 0
Pune
Country [139] 0 0
India
State/province [139] 0 0
Secunderabad
Country [140] 0 0
Indonesia
State/province [140] 0 0
Jakarta
Country [141] 0 0
Israel
State/province [141] 0 0
Afula
Country [142] 0 0
Israel
State/province [142] 0 0
Ashkelon
Country [143] 0 0
Israel
State/province [143] 0 0
Givatayim
Country [144] 0 0
Israel
State/province [144] 0 0
Haifa
Country [145] 0 0
Israel
State/province [145] 0 0
Holon
Country [146] 0 0
Israel
State/province [146] 0 0
Nahariya
Country [147] 0 0
Israel
State/province [147] 0 0
Nazareth
Country [148] 0 0
Israel
State/province [148] 0 0
Rehovot
Country [149] 0 0
Israel
State/province [149] 0 0
Tel Aviv
Country [150] 0 0
Italy
State/province [150] 0 0
Ascoli Piceno
Country [151] 0 0
Italy
State/province [151] 0 0
Borgo San Lorenzo
Country [152] 0 0
Italy
State/province [152] 0 0
Chieti
Country [153] 0 0
Italy
State/province [153] 0 0
Fidenza
Country [154] 0 0
Italy
State/province [154] 0 0
Merate
Country [155] 0 0
Italy
State/province [155] 0 0
Milano
Country [156] 0 0
Italy
State/province [156] 0 0
Novara
Country [157] 0 0
Italy
State/province [157] 0 0
Padova
Country [158] 0 0
Italy
State/province [158] 0 0
Palermo
Country [159] 0 0
Italy
State/province [159] 0 0
Pavia
Country [160] 0 0
Italy
State/province [160] 0 0
Perugia
Country [161] 0 0
Italy
State/province [161] 0 0
San Daniele Del Friuli
Country [162] 0 0
Italy
State/province [162] 0 0
Sassari
Country [163] 0 0
Italy
State/province [163] 0 0
Torino
Country [164] 0 0
Italy
State/province [164] 0 0
Treviso
Country [165] 0 0
Korea, Republic of
State/province [165] 0 0
Anyang
Country [166] 0 0
Korea, Republic of
State/province [166] 0 0
Daegu
Country [167] 0 0
Korea, Republic of
State/province [167] 0 0
Goyang
Country [168] 0 0
Korea, Republic of
State/province [168] 0 0
Gwangju
Country [169] 0 0
Korea, Republic of
State/province [169] 0 0
Seongnam
Country [170] 0 0
Korea, Republic of
State/province [170] 0 0
Seoul
Country [171] 0 0
Lithuania
State/province [171] 0 0
Kaunas
Country [172] 0 0
Lithuania
State/province [172] 0 0
Vilnius
Country [173] 0 0
Malaysia
State/province [173] 0 0
Kuching
Country [174] 0 0
Malaysia
State/province [174] 0 0
Penang
Country [175] 0 0
Malaysia
State/province [175] 0 0
Taiping
Country [176] 0 0
Mexico
State/province [176] 0 0
Acapulco
Country [177] 0 0
Mexico
State/province [177] 0 0
Aguascalientes
Country [178] 0 0
Mexico
State/province [178] 0 0
Guadalajara
Country [179] 0 0
Mexico
State/province [179] 0 0
Mexico Df
Country [180] 0 0
Mexico
State/province [180] 0 0
Monterrey
Country [181] 0 0
Mexico
State/province [181] 0 0
San Luis Potosi
Country [182] 0 0
Mexico
State/province [182] 0 0
Veracruz
Country [183] 0 0
Morocco
State/province [183] 0 0
Marrakech
Country [184] 0 0
Morocco
State/province [184] 0 0
Meknes
Country [185] 0 0
Netherlands
State/province [185] 0 0
Almelo
Country [186] 0 0
Netherlands
State/province [186] 0 0
Amsterdam
Country [187] 0 0
Netherlands
State/province [187] 0 0
Breda
Country [188] 0 0
Netherlands
State/province [188] 0 0
Delft
Country [189] 0 0
Netherlands
State/province [189] 0 0
Den Haag
Country [190] 0 0
Netherlands
State/province [190] 0 0
Ede
Country [191] 0 0
Netherlands
State/province [191] 0 0
Eindhoven
Country [192] 0 0
Netherlands
State/province [192] 0 0
Gouda
Country [193] 0 0
Netherlands
State/province [193] 0 0
Harderwijk
Country [194] 0 0
Netherlands
State/province [194] 0 0
Heerlen
Country [195] 0 0
Netherlands
State/province [195] 0 0
Hengelo
Country [196] 0 0
Netherlands
State/province [196] 0 0
Hoogeveen
Country [197] 0 0
Netherlands
State/province [197] 0 0
Hoorn
Country [198] 0 0
Netherlands
State/province [198] 0 0
Leeuwarden
Country [199] 0 0
Netherlands
State/province [199] 0 0
Nijmegen
Country [200] 0 0
Netherlands
State/province [200] 0 0
Rotterdam
Country [201] 0 0
Netherlands
State/province [201] 0 0
Sittard-Geleen
Country [202] 0 0
Netherlands
State/province [202] 0 0
Sneek
Country [203] 0 0
Netherlands
State/province [203] 0 0
Tilburg
Country [204] 0 0
Netherlands
State/province [204] 0 0
Venlo
Country [205] 0 0
Netherlands
State/province [205] 0 0
Zoetermeer
Country [206] 0 0
Netherlands
State/province [206] 0 0
Zwolle
Country [207] 0 0
New Zealand
State/province [207] 0 0
Christchurch
Country [208] 0 0
New Zealand
State/province [208] 0 0
Dunedin
Country [209] 0 0
New Zealand
State/province [209] 0 0
Nelson
Country [210] 0 0
Norway
State/province [210] 0 0
Bergen
Country [211] 0 0
Norway
State/province [211] 0 0
Flekkefjord
Country [212] 0 0
Norway
State/province [212] 0 0
Lørenskog
Country [213] 0 0
Norway
State/province [213] 0 0
Oslo
Country [214] 0 0
Panama
State/province [214] 0 0
Panama
Country [215] 0 0
Peru
State/province [215] 0 0
Lima
Country [216] 0 0
Philippines
State/province [216] 0 0
Quezon City
Country [217] 0 0
Poland
State/province [217] 0 0
Chojnice
Country [218] 0 0
Poland
State/province [218] 0 0
Gdansk
Country [219] 0 0
Poland
State/province [219] 0 0
Gdynia-Redlowo
Country [220] 0 0
Poland
State/province [220] 0 0
Katowice
Country [221] 0 0
Poland
State/province [221] 0 0
Lodz
Country [222] 0 0
Poland
State/province [222] 0 0
Lublin
Country [223] 0 0
Poland
State/province [223] 0 0
Ostrowiec Swietokrzyski
Country [224] 0 0
Poland
State/province [224] 0 0
Pulawy
Country [225] 0 0
Poland
State/province [225] 0 0
Torun
Country [226] 0 0
Poland
State/province [226] 0 0
Tychy
Country [227] 0 0
Poland
State/province [227] 0 0
Warszawa
Country [228] 0 0
Poland
State/province [228] 0 0
Wroclaw
Country [229] 0 0
Portugal
State/province [229] 0 0
Amadora
Country [230] 0 0
Portugal
State/province [230] 0 0
Braga
Country [231] 0 0
Portugal
State/province [231] 0 0
Coimbra
Country [232] 0 0
Portugal
State/province [232] 0 0
Setubal
Country [233] 0 0
Puerto Rico
State/province [233] 0 0
San Juan
Country [234] 0 0
Russian Federation
State/province [234] 0 0
Barnaul
Country [235] 0 0
Russian Federation
State/province [235] 0 0
Chelyabinsk
Country [236] 0 0
Russian Federation
State/province [236] 0 0
Ekaterinburg
Country [237] 0 0
Russian Federation
State/province [237] 0 0
Kemerovo
Country [238] 0 0
Russian Federation
State/province [238] 0 0
Moscow
Country [239] 0 0
Russian Federation
State/province [239] 0 0
Nizhny Novgorod
Country [240] 0 0
Russian Federation
State/province [240] 0 0
Nizniy Novgorod
Country [241] 0 0
Russian Federation
State/province [241] 0 0
Novosibirsk-117
Country [242] 0 0
Russian Federation
State/province [242] 0 0
Novosibirsk
Country [243] 0 0
Russian Federation
State/province [243] 0 0
Penza
Country [244] 0 0
Russian Federation
State/province [244] 0 0
Perm
Country [245] 0 0
Russian Federation
State/province [245] 0 0
Petrozavodsk
Country [246] 0 0
Russian Federation
State/province [246] 0 0
Rostov-Na-Donu
Country [247] 0 0
Russian Federation
State/province [247] 0 0
Ryazan
Country [248] 0 0
Russian Federation
State/province [248] 0 0
Saint-Petersburg
Country [249] 0 0
Russian Federation
State/province [249] 0 0
Samara
Country [250] 0 0
Russian Federation
State/province [250] 0 0
Saratov
Country [251] 0 0
Russian Federation
State/province [251] 0 0
St-Petersburg
Country [252] 0 0
Russian Federation
State/province [252] 0 0
Tomsk
Country [253] 0 0
Russian Federation
State/province [253] 0 0
Tyumen
Country [254] 0 0
Russian Federation
State/province [254] 0 0
Voronezh
Country [255] 0 0
Russian Federation
State/province [255] 0 0
Yaroslavl
Country [256] 0 0
Slovakia
State/province [256] 0 0
Kosice
Country [257] 0 0
Slovakia
State/province [257] 0 0
Levice
Country [258] 0 0
Slovakia
State/province [258] 0 0
Nitra
Country [259] 0 0
Slovakia
State/province [259] 0 0
Poprad
Country [260] 0 0
Slovakia
State/province [260] 0 0
Trnava
Country [261] 0 0
South Africa
State/province [261] 0 0
Amanzimtoti
Country [262] 0 0
South Africa
State/province [262] 0 0
Bloemfontein
Country [263] 0 0
South Africa
State/province [263] 0 0
Cape Town
Country [264] 0 0
South Africa
State/province [264] 0 0
Durban
Country [265] 0 0
South Africa
State/province [265] 0 0
Johannesburg
Country [266] 0 0
South Africa
State/province [266] 0 0
Port Elizabeth
Country [267] 0 0
South Africa
State/province [267] 0 0
Pretoria
Country [268] 0 0
South Africa
State/province [268] 0 0
Randburg
Country [269] 0 0
South Africa
State/province [269] 0 0
Scottburgh
Country [270] 0 0
South Africa
State/province [270] 0 0
Umhlanga Rocks
Country [271] 0 0
Spain
State/province [271] 0 0
Barcelona
Country [272] 0 0
Spain
State/province [272] 0 0
Madrid
Country [273] 0 0
Spain
State/province [273] 0 0
Santiago De Compostela
Country [274] 0 0
Spain
State/province [274] 0 0
Sevilla
Country [275] 0 0
Sweden
State/province [275] 0 0
Göteborg
Country [276] 0 0
Sweden
State/province [276] 0 0
Malmo
Country [277] 0 0
Sweden
State/province [277] 0 0
Malmö
Country [278] 0 0
Sweden
State/province [278] 0 0
Ostersund
Country [279] 0 0
Sweden
State/province [279] 0 0
Stockolm
Country [280] 0 0
Taiwan
State/province [280] 0 0
Kaohsiung
Country [281] 0 0
Taiwan
State/province [281] 0 0
Taichung
Country [282] 0 0
Taiwan
State/province [282] 0 0
Tainan Hsien
Country [283] 0 0
Taiwan
State/province [283] 0 0
Taipei
Country [284] 0 0
Thailand
State/province [284] 0 0
Bangkok-Noi
Country [285] 0 0
Thailand
State/province [285] 0 0
Bangkok
Country [286] 0 0
Thailand
State/province [286] 0 0
Muang
Country [287] 0 0
Turkey
State/province [287] 0 0
Edirne
Country [288] 0 0
Turkey
State/province [288] 0 0
Istanbul
Country [289] 0 0
Turkey
State/province [289] 0 0
Kocaeli
Country [290] 0 0
Ukraine
State/province [290] 0 0
Dnepropetrovsk
Country [291] 0 0
Ukraine
State/province [291] 0 0
Dnipropetrovsk
Country [292] 0 0
Ukraine
State/province [292] 0 0
Ivano-Frankivsk
Country [293] 0 0
Ukraine
State/province [293] 0 0
Kharkiv
Country [294] 0 0
Ukraine
State/province [294] 0 0
Kharkov
Country [295] 0 0
Ukraine
State/province [295] 0 0
Kiev
Country [296] 0 0
Ukraine
State/province [296] 0 0
Lutsk
Country [297] 0 0
Ukraine
State/province [297] 0 0
Odessa
Country [298] 0 0
Ukraine
State/province [298] 0 0
Ternopil
Country [299] 0 0
Ukraine
State/province [299] 0 0
Uzhgorod
Country [300] 0 0
Ukraine
State/province [300] 0 0
Zaporizhzhia
Country [301] 0 0
Venezuela
State/province [301] 0 0
Caracas
Country [302] 0 0
Venezuela
State/province [302] 0 0
Maracay

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective is to evaluate whether once weekly subcutaneous (SC) injection of
idrabiotaparinux sodium (biotinylated idraparinux) 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).
Trial website
https://clinicaltrials.gov/show/NCT00580216
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00580216