Evaluation of Weekly Subcutaneous Biotinylated Idraparinux Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation - Full Text View

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 )

First Received on December 21, 2007. Last Updated on April 27, 2011 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00580216

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 III

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin SR 34006 Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

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-Aventis:

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 February 09, 2012