Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation



Status:Terminated
Conditions:Atrial Fibrillation, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2007
End Date:October 2010

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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

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).

The end of the study is defined by a common study end date for all participants, defined as
9 months (39 weeks) after the last participant randomized.

All participants will receive oral warfarin (or matching placebo) and weekly SC injections
of idrabiotaparinux sodium (or matching placebo) up to 6 months before the common study end
date. All participants are expected to be treated for at least 6 months.

All participants will have then an 6-month observational period after cessation of study
treatment.

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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