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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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0
2007-004817-33
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Secondary ID [2]
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0
EFC10295
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Universal Trial Number (UTN)
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Trial acronym
BOREALIS-AF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
0
0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE)
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Assessment method [1]
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Timepoint [1]
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From randomization up to the end of the treatment period (minimum of 6 months)
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Secondary outcome [1]
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Components of the primary study outcome measure:
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Assessment method [1]
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Timepoint [1]
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From randomization up to the end of the treatment period (minimum of 6 months)
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Secondary outcome [2]
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Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death
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Assessment method [2]
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Timepoint [2]
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From randomization up to the end of the treatment period (minimum of 6 months)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2010
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Sample size
Target
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Accrual to date
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Final
3773
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Investigational Site Number 036006 - Adelaide
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Recruitment hospital [2]
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Sanofi-Aventis Investigational Site Number 036003 - Auchenflower
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Sanofi-Aventis Investigational Site Number 036008 - Box Hill
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Sanofi-Aventis Investigational Site Number 036005 - Coffs Harbour
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Sanofi-Aventis Investigational Site Number 036001 - Kippa Ring
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Sanofi-Aventis Investigational Site Number 036002 - Kippa Ring
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Sanofi-Aventis Investigational Site Number 036009 - Launceston
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Sanofi-Aventis Investigational Site Number 036010 - Woden
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Recruitment postcode(s) [1]
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5035 - Adelaide
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4066 - Auchenflower
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3128 - Box Hill
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2450 - Coffs Harbour
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4021 - Kippa Ring
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7250 - Launceston
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Recruitment postcode(s) [7]
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2606 - Woden
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Recruitment outside Australia
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Tours Cedex 1
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Vandoeuvre Les Nancy Cedex
Query!
Country [123]
0
0
Greece
Query!
State/province [123]
0
0
Athens
Query!
Country [124]
0
0
Greece
Query!
State/province [124]
0
0
Chalkida
Query!
Country [125]
0
0
Greece
Query!
State/province [125]
0
0
Chios
Query!
Country [126]
0
0
Greece
Query!
State/province [126]
0
0
Elefsina
Query!
Country [127]
0
0
Guatemala
Query!
State/province [127]
0
0
Guatemala
Query!
Country [128]
0
0
India
Query!
State/province [128]
0
0
Ahmedabad
Query!
Country [129]
0
0
India
Query!
State/province [129]
0
0
Bangalore
Query!
Country [130]
0
0
India
Query!
State/province [130]
0
0
Chennai
Query!
Country [131]
0
0
India
Query!
State/province [131]
0
0
Coimbatore
Query!
Country [132]
0
0
India
Query!
State/province [132]
0
0
Lucknow
Query!
Country [133]
0
0
India
Query!
State/province [133]
0
0
Mumbai
Query!
Country [134]
0
0
India
Query!
State/province [134]
0
0
Mysore
Query!
Country [135]
0
0
India
Query!
State/province [135]
0
0
Nashik
Query!
Country [136]
0
0
India
Query!
State/province [136]
0
0
New Delhi
Query!
Country [137]
0
0
India
Query!
State/province [137]
0
0
Pune.
Query!
Country [138]
0
0
India
Query!
State/province [138]
0
0
Pune
Query!
Country [139]
0
0
India
Query!
State/province [139]
0
0
Secunderabad
Query!
Country [140]
0
0
Indonesia
Query!
State/province [140]
0
0
Jakarta
Query!
Country [141]
0
0
Israel
Query!
State/province [141]
0
0
Afula
Query!
Country [142]
0
0
Israel
Query!
State/province [142]
0
0
Ashkelon
Query!
Country [143]
0
0
Israel
Query!
State/province [143]
0
0
Givatayim
Query!
Country [144]
0
0
Israel
Query!
State/province [144]
0
0
Haifa
Query!
Country [145]
0
0
Israel
Query!
State/province [145]
0
0
Holon
Query!
Country [146]
0
0
Israel
Query!
State/province [146]
0
0
Nahariya
Query!
Country [147]
0
0
Israel
Query!
State/province [147]
0
0
Nazareth
Query!
Country [148]
0
0
Israel
Query!
State/province [148]
0
0
Rehovot
Query!
Country [149]
0
0
Israel
Query!
State/province [149]
0
0
Tel Aviv
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Ascoli Piceno
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Borgo San Lorenzo
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Chieti
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Fidenza
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Merate
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
Milano
Query!
Country [156]
0
0
Italy
Query!
State/province [156]
0
0
Novara
Query!
Country [157]
0
0
Italy
Query!
State/province [157]
0
0
Padova
Query!
Country [158]
0
0
Italy
Query!
State/province [158]
0
0
Palermo
Query!
Country [159]
0
0
Italy
Query!
State/province [159]
0
0
Pavia
Query!
Country [160]
0
0
Italy
Query!
State/province [160]
0
0
Perugia
Query!
Country [161]
0
0
Italy
Query!
State/province [161]
0
0
San Daniele Del Friuli
Query!
Country [162]
0
0
Italy
Query!
State/province [162]
0
0
Sassari
Query!
Country [163]
0
0
Italy
Query!
State/province [163]
0
0
Torino
Query!
Country [164]
0
0
Italy
Query!
State/province [164]
0
0
Treviso
Query!
Country [165]
0
0
Korea, Republic of
Query!
State/province [165]
0
0
Anyang
Query!
Country [166]
0
0
Korea, Republic of
Query!
State/province [166]
0
0
Daegu
Query!
Country [167]
0
0
Korea, Republic of
Query!
State/province [167]
0
0
Goyang
Query!
Country [168]
0
0
Korea, Republic of
Query!
State/province [168]
0
0
Gwangju
Query!
Country [169]
0
0
Korea, Republic of
Query!
State/province [169]
0
0
Seongnam
Query!
Country [170]
0
0
Korea, Republic of
Query!
State/province [170]
0
0
Seoul
Query!
Country [171]
0
0
Lithuania
Query!
State/province [171]
0
0
Kaunas
Query!
Country [172]
0
0
Lithuania
Query!
State/province [172]
0
0
Vilnius
Query!
Country [173]
0
0
Malaysia
Query!
State/province [173]
0
0
Kuching
Query!
Country [174]
0
0
Malaysia
Query!
State/province [174]
0
0
Penang
Query!
Country [175]
0
0
Malaysia
Query!
State/province [175]
0
0
Taiping
Query!
Country [176]
0
0
Mexico
Query!
State/province [176]
0
0
Acapulco
Query!
Country [177]
0
0
Mexico
Query!
State/province [177]
0
0
Aguascalientes
Query!
Country [178]
0
0
Mexico
Query!
State/province [178]
0
0
Guadalajara
Query!
Country [179]
0
0
Mexico
Query!
State/province [179]
0
0
Mexico Df
Query!
Country [180]
0
0
Mexico
Query!
State/province [180]
0
0
Monterrey
Query!
Country [181]
0
0
Mexico
Query!
State/province [181]
0
0
San Luis Potosi
Query!
Country [182]
0
0
Mexico
Query!
State/province [182]
0
0
Veracruz
Query!
Country [183]
0
0
Morocco
Query!
State/province [183]
0
0
Marrakech
Query!
Country [184]
0
0
Morocco
Query!
State/province [184]
0
0
Meknes
Query!
Country [185]
0
0
Netherlands
Query!
State/province [185]
0
0
Almelo
Query!
Country [186]
0
0
Netherlands
Query!
State/province [186]
0
0
Amsterdam
Query!
Country [187]
0
0
Netherlands
Query!
State/province [187]
0
0
Breda
Query!
Country [188]
0
0
Netherlands
Query!
State/province [188]
0
0
Delft
Query!
Country [189]
0
0
Netherlands
Query!
State/province [189]
0
0
Den Haag
Query!
Country [190]
0
0
Netherlands
Query!
State/province [190]
0
0
Ede
Query!
Country [191]
0
0
Netherlands
Query!
State/province [191]
0
0
Eindhoven
Query!
Country [192]
0
0
Netherlands
Query!
State/province [192]
0
0
Gouda
Query!
Country [193]
0
0
Netherlands
Query!
State/province [193]
0
0
Harderwijk
Query!
Country [194]
0
0
Netherlands
Query!
State/province [194]
0
0
Heerlen
Query!
Country [195]
0
0
Netherlands
Query!
State/province [195]
0
0
Hengelo
Query!
Country [196]
0
0
Netherlands
Query!
State/province [196]
0
0
Hoogeveen
Query!
Country [197]
0
0
Netherlands
Query!
State/province [197]
0
0
Hoorn
Query!
Country [198]
0
0
Netherlands
Query!
State/province [198]
0
0
Leeuwarden
Query!
Country [199]
0
0
Netherlands
Query!
State/province [199]
0
0
Nijmegen
Query!
Country [200]
0
0
Netherlands
Query!
State/province [200]
0
0
Rotterdam
Query!
Country [201]
0
0
Netherlands
Query!
State/province [201]
0
0
Sittard-Geleen
Query!
Country [202]
0
0
Netherlands
Query!
State/province [202]
0
0
Sneek
Query!
Country [203]
0
0
Netherlands
Query!
State/province [203]
0
0
Tilburg
Query!
Country [204]
0
0
Netherlands
Query!
State/province [204]
0
0
Venlo
Query!
Country [205]
0
0
Netherlands
Query!
State/province [205]
0
0
Zoetermeer
Query!
Country [206]
0
0
Netherlands
Query!
State/province [206]
0
0
Zwolle
Query!
Country [207]
0
0
New Zealand
Query!
State/province [207]
0
0
Christchurch
Query!
Country [208]
0
0
New Zealand
Query!
State/province [208]
0
0
Dunedin
Query!
Country [209]
0
0
New Zealand
Query!
State/province [209]
0
0
Nelson
Query!
Country [210]
0
0
Norway
Query!
State/province [210]
0
0
Bergen
Query!
Country [211]
0
0
Norway
Query!
State/province [211]
0
0
Flekkefjord
Query!
Country [212]
0
0
Norway
Query!
State/province [212]
0
0
Lørenskog
Query!
Country [213]
0
0
Norway
Query!
State/province [213]
0
0
Oslo
Query!
Country [214]
0
0
Panama
Query!
State/province [214]
0
0
Panama
Query!
Country [215]
0
0
Peru
Query!
State/province [215]
0
0
Lima
Query!
Country [216]
0
0
Philippines
Query!
State/province [216]
0
0
Quezon City
Query!
Country [217]
0
0
Poland
Query!
State/province [217]
0
0
Chojnice
Query!
Country [218]
0
0
Poland
Query!
State/province [218]
0
0
Gdansk
Query!
Country [219]
0
0
Poland
Query!
State/province [219]
0
0
Gdynia-Redlowo
Query!
Country [220]
0
0
Poland
Query!
State/province [220]
0
0
Katowice
Query!
Country [221]
0
0
Poland
Query!
State/province [221]
0
0
Lodz
Query!
Country [222]
0
0
Poland
Query!
State/province [222]
0
0
Lublin
Query!
Country [223]
0
0
Poland
Query!
State/province [223]
0
0
Ostrowiec Swietokrzyski
Query!
Country [224]
0
0
Poland
Query!
State/province [224]
0
0
Pulawy
Query!
Country [225]
0
0
Poland
Query!
State/province [225]
0
0
Torun
Query!
Country [226]
0
0
Poland
Query!
State/province [226]
0
0
Tychy
Query!
Country [227]
0
0
Poland
Query!
State/province [227]
0
0
Warszawa
Query!
Country [228]
0
0
Poland
Query!
State/province [228]
0
0
Wroclaw
Query!
Country [229]
0
0
Portugal
Query!
State/province [229]
0
0
Amadora
Query!
Country [230]
0
0
Portugal
Query!
State/province [230]
0
0
Braga
Query!
Country [231]
0
0
Portugal
Query!
State/province [231]
0
0
Coimbra
Query!
Country [232]
0
0
Portugal
Query!
State/province [232]
0
0
Setubal
Query!
Country [233]
0
0
Puerto Rico
Query!
State/province [233]
0
0
San Juan
Query!
Country [234]
0
0
Russian Federation
Query!
State/province [234]
0
0
Barnaul
Query!
Country [235]
0
0
Russian Federation
Query!
State/province [235]
0
0
Chelyabinsk
Query!
Country [236]
0
0
Russian Federation
Query!
State/province [236]
0
0
Ekaterinburg
Query!
Country [237]
0
0
Russian Federation
Query!
State/province [237]
0
0
Kemerovo
Query!
Country [238]
0
0
Russian Federation
Query!
State/province [238]
0
0
Moscow
Query!
Country [239]
0
0
Russian Federation
Query!
State/province [239]
0
0
Nizhny Novgorod
Query!
Country [240]
0
0
Russian Federation
Query!
State/province [240]
0
0
Nizniy Novgorod
Query!
Country [241]
0
0
Russian Federation
Query!
State/province [241]
0
0
Novosibirsk-117
Query!
Country [242]
0
0
Russian Federation
Query!
State/province [242]
0
0
Novosibirsk
Query!
Country [243]
0
0
Russian Federation
Query!
State/province [243]
0
0
Penza
Query!
Country [244]
0
0
Russian Federation
Query!
State/province [244]
0
0
Perm
Query!
Country [245]
0
0
Russian Federation
Query!
State/province [245]
0
0
Petrozavodsk
Query!
Country [246]
0
0
Russian Federation
Query!
State/province [246]
0
0
Rostov-Na-Donu
Query!
Country [247]
0
0
Russian Federation
Query!
State/province [247]
0
0
Ryazan
Query!
Country [248]
0
0
Russian Federation
Query!
State/province [248]
0
0
Saint-Petersburg
Query!
Country [249]
0
0
Russian Federation
Query!
State/province [249]
0
0
Samara
Query!
Country [250]
0
0
Russian Federation
Query!
State/province [250]
0
0
Saratov
Query!
Country [251]
0
0
Russian Federation
Query!
State/province [251]
0
0
St-Petersburg
Query!
Country [252]
0
0
Russian Federation
Query!
State/province [252]
0
0
Tomsk
Query!
Country [253]
0
0
Russian Federation
Query!
State/province [253]
0
0
Tyumen
Query!
Country [254]
0
0
Russian Federation
Query!
State/province [254]
0
0
Voronezh
Query!
Country [255]
0
0
Russian Federation
Query!
State/province [255]
0
0
Yaroslavl
Query!
Country [256]
0
0
Slovakia
Query!
State/province [256]
0
0
Kosice
Query!
Country [257]
0
0
Slovakia
Query!
State/province [257]
0
0
Levice
Query!
Country [258]
0
0
Slovakia
Query!
State/province [258]
0
0
Nitra
Query!
Country [259]
0
0
Slovakia
Query!
State/province [259]
0
0
Poprad
Query!
Country [260]
0
0
Slovakia
Query!
State/province [260]
0
0
Trnava
Query!
Country [261]
0
0
South Africa
Query!
State/province [261]
0
0
Amanzimtoti
Query!
Country [262]
0
0
South Africa
Query!
State/province [262]
0
0
Bloemfontein
Query!
Country [263]
0
0
South Africa
Query!
State/province [263]
0
0
Cape Town
Query!
Country [264]
0
0
South Africa
Query!
State/province [264]
0
0
Durban
Query!
Country [265]
0
0
South Africa
Query!
State/province [265]
0
0
Johannesburg
Query!
Country [266]
0
0
South Africa
Query!
State/province [266]
0
0
Port Elizabeth
Query!
Country [267]
0
0
South Africa
Query!
State/province [267]
0
0
Pretoria
Query!
Country [268]
0
0
South Africa
Query!
State/province [268]
0
0
Randburg
Query!
Country [269]
0
0
South Africa
Query!
State/province [269]
0
0
Scottburgh
Query!
Country [270]
0
0
South Africa
Query!
State/province [270]
0
0
Umhlanga Rocks
Query!
Country [271]
0
0
Spain
Query!
State/province [271]
0
0
Barcelona
Query!
Country [272]
0
0
Spain
Query!
State/province [272]
0
0
Madrid
Query!
Country [273]
0
0
Spain
Query!
State/province [273]
0
0
Santiago De Compostela
Query!
Country [274]
0
0
Spain
Query!
State/province [274]
0
0
Sevilla
Query!
Country [275]
0
0
Sweden
Query!
State/province [275]
0
0
Göteborg
Query!
Country [276]
0
0
Sweden
Query!
State/province [276]
0
0
Malmo
Query!
Country [277]
0
0
Sweden
Query!
State/province [277]
0
0
Malmö
Query!
Country [278]
0
0
Sweden
Query!
State/province [278]
0
0
Ostersund
Query!
Country [279]
0
0
Sweden
Query!
State/province [279]
0
0
Stockolm
Query!
Country [280]
0
0
Taiwan
Query!
State/province [280]
0
0
Kaohsiung
Query!
Country [281]
0
0
Taiwan
Query!
State/province [281]
0
0
Taichung
Query!
Country [282]
0
0
Taiwan
Query!
State/province [282]
0
0
Tainan Hsien
Query!
Country [283]
0
0
Taiwan
Query!
State/province [283]
0
0
Taipei
Query!
Country [284]
0
0
Thailand
Query!
State/province [284]
0
0
Bangkok-Noi
Query!
Country [285]
0
0
Thailand
Query!
State/province [285]
0
0
Bangkok
Query!
Country [286]
0
0
Thailand
Query!
State/province [286]
0
0
Muang
Query!
Country [287]
0
0
Turkey
Query!
State/province [287]
0
0
Edirne
Query!
Country [288]
0
0
Turkey
Query!
State/province [288]
0
0
Istanbul
Query!
Country [289]
0
0
Turkey
Query!
State/province [289]
0
0
Kocaeli
Query!
Country [290]
0
0
Ukraine
Query!
State/province [290]
0
0
Dnepropetrovsk
Query!
Country [291]
0
0
Ukraine
Query!
State/province [291]
0
0
Dnipropetrovsk
Query!
Country [292]
0
0
Ukraine
Query!
State/province [292]
0
0
Ivano-Frankivsk
Query!
Country [293]
0
0
Ukraine
Query!
State/province [293]
0
0
Kharkiv
Query!
Country [294]
0
0
Ukraine
Query!
State/province [294]
0
0
Kharkov
Query!
Country [295]
0
0
Ukraine
Query!
State/province [295]
0
0
Kiev
Query!
Country [296]
0
0
Ukraine
Query!
State/province [296]
0
0
Lutsk
Query!
Country [297]
0
0
Ukraine
Query!
State/province [297]
0
0
Odessa
Query!
Country [298]
0
0
Ukraine
Query!
State/province [298]
0
0
Ternopil
Query!
Country [299]
0
0
Ukraine
Query!
State/province [299]
0
0
Uzhgorod
Query!
Country [300]
0
0
Ukraine
Query!
State/province [300]
0
0
Zaporizhzhia
Query!
Country [301]
0
0
Venezuela
Query!
State/province [301]
0
0
Caracas
Query!
Country [302]
0
0
Venezuela
Query!
State/province [302]
0
0
Maracay
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Sanofi
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
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Trial website
https://clinicaltrials.gov/study/NCT00580216
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Trial related presentations / publications
Buller HR, Halperin J, Hankey GJ, Pillion G, Prins MH, Raskob GE. Comparison of idrabiotaparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: the Borealis-Atrial Fibrillation Study. J Thromb Haemost. 2014 Jun;12(6):824-30. doi: 10.1111/jth.12546.
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Public notes
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Sanofi
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Results publications and other study-related documents
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Journal
Buller HR, Halperin J, Hankey GJ, Pillion G, Prins...
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https://clinicaltrials.gov/study/NCT00580216
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