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)


Tracking Information

Start Date  ICMJEDecember 2007
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2008)		composite of all strokes or non central nervous system (CNS) systemic embolic events (SE) [ Time Frame: end of study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: December 21, 2007)		composite of all strokes or non central nervous system (CNS) systemic embolic events (SE) [ Time Frame: end of study ]
Change HistoryComplete list of historical versions of study NCT00580216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: September 19, 2008)
  • separate components of the primary study outcome [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • composite (stroke or non CNS SE or major bleeding or death) [ Time Frame: end of study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: December 21, 2007)
  • separate components of the primary study outcome [ Time Frame: end of study ]
  • composite (stroke or non CNS SE or major bleeding or death) [ Time Frame: end of study ]

Descriptive Information

Brief Title  ICMJEEvaluation of Weekly Subcutaneous Biotinylated Idraparinux Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
Official Title  ICMJEA 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
Brief Summary

The objective of this study is to evaluate wether the new investigational, neutralizable blood thinner (anticoagulant) "biotinylated idraparinux", administered once weekly under the skin, is at least as efficient to prevent clots in brain and in the other organs than the standard of care with warfarin an oral anticoagulant whose doses are adjusted according to a regular monitoring of a blood coagulation test (INR) in patients with heart rhythm disorder called "atrial fibrillation".

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJEAtrial Fibrillation
Intervention  ICMJE
  • Drug: SSR126517E "biotinylated idraparinux"
    once-weekly subcutaneous injection
  • Drug: warfarin
    oral INR adjusted-dose
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: SSR126517E "biotinylated idraparinux"
  • 2: Active Comparator
    Intervention: Drug: warfarin

Recruitment Information

Estimated Enrollment  ICMJE9600
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 Transient Ischemic Attack within previous 5 days
  • Transient atrial fibrillation 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
  • Pregnant or childbearing potential without proper contraceptive measures or breast feeding.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For site information, send an email with site number toGV-Contact-us@sanofi-aventis.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belarus,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Costa Rica,   Croatia,   Czech Republic,   Denmark,   Egypt,   Estonia,   Finland,   France,   Greece,   Guatemala,   India,   Indonesia,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   Morocco,   Netherlands,   New Zealand,   Norway,   Panama,   Peru,   Philippines,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   Venezuela

Administrative Information

NCT ID  ICMJENCT00580216
Responsible PartyICD Study Director, sanofi-aventis
Study ID Numbers  ICMJEEFC10295, EudraCT 2007-004817-33
Study Sponsor  ICMJESanofi-Aventis
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:ICDSanofi-Aventis
Information Provided BySanofi-Aventis