The AMADEUS Trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation
The AMADEUS Trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation
This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.
The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.
Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.
Inclusion Criteria:
ECG-documented atrial fibrillation (AF) and an indication for long-term vitamin K antagonist (VKA) therapy based on the presence of at least one of the following risk factors:
Written informed consent
Exclusion Criteria:
Fort Lauderdale, Florida, United States
Dallas, Texas, United States
Bondi Junction, Cairns, Camperdown, Miranda, Perth, Australia
South Australia, Tasmania, Victoria, Australia
St. John's, Newfoundland and Labrador, Canada
Faaborg, Fredericia, Frederiksberg, Frederikshavn, Hellerup, Denmark
Herlev, Hillerod, Holstebro, Horsens, Kalundborg, Kobenhavn, Denmark
Kolding, Nykobing Mors, Odense, Skive, Svendborg, Denmark
Bourg En Bresse, Dreux, Lille, Marseille, Maubeuge, Mulhouse, France
Nantes, Nice, Paris, Poitiers, Rennes, Saint Denis, France
Saint-Etienne, Toulouse, France
Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia, Italy
Torino, Treviso, Italy
Almelo, Amersfoort, Breda, Boxmeer, Delft, Dordrecht, Netherlands
Eindhoven, Enschede, Gorinchem, Gouda, Groningen, Harderwijk, Netherlands
Heerlen, Hilversum, Rotterdam, Sneek, Spijkenisse, Tiel, Netherlands
Auckland, Christchurch, Hastings, New Zealand
Kielce, Krakow, Opole, Plock, Siedlce, Warszawa, Wroclaw, Poland
Exeter, Dundee, Glasgow, Merseyside, Wirral, United Kingdom
Newscastle Upon Tyne, United Kingdom