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

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).

Conditions

• Atrial Fibrillation

Interventions

DRUG

Idrabiotaparinux sodium

Pre-filled syringes containing: * 0.5 mL for the 3.0 mg dosage; * 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old); * 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years). Subcutaneous injection

DRUG

Warfarin

Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month) Oral administration

DRUG

Placebo (for idrabiotaparinux)

Matching pre-filled syringes containing: * 0.5 mL for the 3.0 mg dosage; * 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old); * 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years). Subcutaneous injection

DRUG

Placebo (for warfarin)

Warfarin matching capsules Oral administration

DRUG

Avidin

Vial containing 105 mg of lyophilized powder for dilution Intravenous infusion for 30 minutes

DRUG

Placebo (for avidin)

Vial containing 105 mg of matching lyophilized powder for dissolution Intravenous infusion for 30 minutes

Sponsors & Collaborators

• Sanofi

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2010-10-31

Completion

2010-10-31

Countries

• United States
• Argentina
• Australia
• Austria
• Belarus
• Brazil
• Bulgaria
• Canada
• Chile
• Colombia
• Costa Rica
• Croatia
• Czechia
• Denmark
• Egypt
• Estonia
• Finland
• France
• Greece
• Guatemala
• India
• Indonesia
• Israel
• Italy
• Lithuania
• Malaysia
• Mexico
• Morocco
• Netherlands
• New Zealand
• Norway
• Panama
• Peru
• Philippines
• Poland
• Portugal
• Puerto Rico
• Russia
• Slovakia
• South Africa
• South Korea
• Spain
• Sweden
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine
• Venezuela

Study Locations