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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
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
3773
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
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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/study/NCT00580216
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.
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/study/NCT00580216