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

Phase 3

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Drug: Idrabiotaparinux sodium; Drug: Warfarin; Drug: Placebo (for warfarin); Drug: Placebo (for idrabiotaparinux); Drug: Placebo (for avidin); Drug: Avidin

• Registration Number: NCT00580216
• Lead Sponsor: Sanofi

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-24
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-19
• Disposition First Submitted QC: 2016-02-19
• Last Update Submitted: 2016-02-19
• Disposition First Posted: 2016-03-21
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3773

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Idrabiotaparinux	Placebo (for warfarin)	Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).
Warfarin	Placebo (for idrabiotaparinux)	Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
Warfarin	Placebo (for avidin)	Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
Idrabiotaparinux	Idrabiotaparinux sodium	Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).
Warfarin	Warfarin	Warfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
Idrabiotaparinux	Avidin	Idrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).

Primary Outcome Measures

Name	Time	Method
Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE)	From randomization up to the end of the treatment period (minimum of 6 months)

Secondary Outcome Measures

Name	Time	Method
Components of the primary study outcome measure:	From randomization up to the end of the treatment period (minimum of 6 months)
Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death	From randomization up to the end of the treatment period (minimum of 6 months)

Trial Locations

Locations (538)

Sanofi-Aventis Investigational Site Number 840227; 🇺🇸 Mobile, Alabama, United States

Sanofi-Aventis Investigational Site Number 840209; 🇺🇸 Tucson, Arizona, United States

Sanofi-Aventis Investigational Site Number 840255; 🇺🇸 Little Rock, Arkansas, United States

Sanofi-Aventis Investigational Site Number 840224; 🇺🇸 Little Rock, Arkansas, United States

Sanofi-Aventis Investigational Site Number 840179; 🇺🇸 Mountain Home, Arkansas, United States

Sanofi-Aventis Investigational Site Number 840270; 🇺🇸 Beverly Hills, California, United States

Sanofi-Aventis Investigational Site Number 840278; 🇺🇸 Beverly Hills, California, United States

Sanofi-Aventis Investigational Site Number 840241; 🇺🇸 Burbank, California, United States

Sanofi-Aventis Investigational Site Number 840010; 🇺🇸 Corona, California, United States

Sanofi-Aventis Investigational Site Number 840195; 🇺🇸 Encino, California, United States

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