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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:
Sanofi
ClinicalTrials.gov Identifier:
NCT00580216
First received: December 21, 2007
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

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".


Condition Intervention Phase
Atrial Fibrillation
 Drug: SSR126517E "biotinylated idraparinux"
Drug: warfarin
 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:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • composite of all strokes or non central nervous system (CNS) systemic embolic events (SE) [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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: 1 Drug: SSR126517E "biotinylated idraparinux"
once-weekly subcutaneous injection
Active Comparator: 2 Drug: warfarin
oral INR adjusted-dose

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

  Show 538 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00580216     History of Changes
Other Study ID Numbers: EFC10295, EudraCT 2007-004817-33
Study First Received: December 21, 2007
Last Updated: April 27, 2011
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 May 22, 2013