Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
