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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT00580216

Run by

Sanofi

People needed

3773

Starts

2007-12-01

Expected to finish

2010-10-01

Last updated by the study team

2016-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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.
• 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.

Where it is running

• 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
• Sanofi-Aventis Investigational Site Number 840033 — Loma Linda, California, United States
• Sanofi-Aventis Investigational Site Number 840184 — Long Beach, California, United States
• Sanofi-Aventis Investigational Site Number 840183 — Los Banos, California, United States
• Sanofi-Aventis Investigational Site Number 840272 — Northridge, California, United States
• Sanofi-Aventis Investigational Site Number 840213 — Orange, California, United States
• Sanofi-Aventis Investigational Site Number 840009 — Redondo Beach, California, United States
• Sanofi-Aventis Investigational Site Number 840298 — Riverside, California, United States
• Sanofi-Aventis Investigational Site Number 840264 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840275 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840103 — Santa Ana, California, United States
• Sanofi-Aventis Investigational Site Number 840002 — Santa Rosa, California, United States
• Sanofi-Aventis Investigational Site Number 840111 — Torrance, California, United States
• Sanofi-Aventis Investigational Site Number 840118 — Visalia, California, United States
• Sanofi-Aventis Investigational Site Number 840268 — Bridgeport, Connecticut, United States
• Sanofi-Aventis Investigational Site Number 840246 — Bay Pines, Florida, United States
• Sanofi-Aventis Investigational Site Number 840227 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.