Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00070655

Collaborator

(none)

4,673

Enrollment

Locations

Duration (Months)

55.6

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: SR34006 (idraparinux sodium) Injection Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

4673 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Composite of all strokes and non-CNS systemic embolism. []

Secondary Outcome Measures

Separate components of the primary study outcome. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism
hypertension requiring drug treatment
left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure)
age >75 years
age between 65-75 years plus diabetes mellitus, or
age between 65-75 years plus symptomatic coronary artery disease (previous myocardial infarction (MI) or angina pectoris)

Written informed consent

Exclusion Criteria:

Legal lower age limitations (country specific)
Indication for VKA other than AF, including prosthetic heart valves, venous thromboembolism, and planned cardioversion
Transient AF caused by a reversible disorder
Active bleeding or high risk of bleeding
Recent (<15 days) or anticipated invasive procedures with potential for uncontrolled bleeding, including major surgery
Participation in another pharmacotherapeutic study within the prior 30 days
Creatinine clearance <10 mL/min, severe hepatic disease, or bacterial endocarditis
Uncontrolled hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg
Pregnancy or childbearing potential without proper contraceptive measures
Breastfeeding
Any other contraindication listed in the labeling of warfarin or acenocoumarol

Contacts and Locations

Locations

	Site	City	State	Country
1	Cardiology, P.C.	Birmingham	Alabama	United States
2	Oracle Research, a Division of: The Heart Center, P.C.	Huntsville	Alabama	United States
3	Arizona Heart Institute Mesa	Mesa	Arizona	United States
4	Saguaro Clinical Research	Tucson	Arizona	United States
5	Southern Arizona Veterans Affairs Health Care System	Tucson	Arizona	United States
6	Office of Dr. Bowden, D.O.	Healdsburg	California	United States
7	Jerry L. Pettis VA Medical Center	Loma Linda	California	United States
8	Kenneth W. Carr, M.D. Cardiology	Oceanside	California	United States
9	Richard A. Levy, M.D.	San Francisco	California	United States
10	Cardiology Specialists of Orange County	Santa Ana	California	United States
11	Aurora Denver Cardiology Associates	Aurora	Colorado	United States
12	Denver Health and Hospital Authority Adult Medicine Clinic	Denver	Colorado	United States
13	Denver Health and Hospital Authority Eastside Health Clinic	Denver	Colorado	United States
14	Denver Health Medical Center	Denver	Colorado	United States
15	Florida Arrhythmia Consultants	Fort Lauderdale	Florida	United States
16	North Broward Hospital District Cardiovascular Research Institute	Fort Lauderdale	Florida	United States
17	Jacksonville Cardiovascular Clinic	Jacksonville	Florida	United States
18	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States
19	Cardiovascular Center of Sarasota	Sarasota	Florida	United States
20	Wellington Green Family Practice	Wellington	Florida	United States
21	Beacon Medical Research	Indianapolis	Indiana	United States
22	Heart & Vascular Clinic/Advanced Medical Research	Covington	Louisiana	United States
23	The Clinic (Lake Charles Medical & Surgical Clinic)	Lake Charles	Louisiana	United States
24	IMG Healthcare, LLC	New Orleans	Louisiana	United States
25	Baystate Medical Center	Springfield	Massachusetts	United States
26	New Mexico Heart Institute, PA	Albuquerque	New Mexico	United States
27	University of New Mexico Hospital	Albuquerque	New Mexico	United States
28	Practice of James A. Underberg @ Murray Hill Medical Group	New York	New York	United States
29	Duke University Medical Center	Durham	North Carolina	United States
30	The Oregon Health and Science University	Portland	Oregon	United States
31	Blackstone Cardiology Associates, P.C.	Pawtucket	Rhode Island	United States
32	Austin Heart, P.A.	Austin	Texas	United States
33	Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates	Dallas	Texas	United States
34	South Texas Cardiovascular Consultants	San Antonio	Texas	United States
35	LDS Hospital	Salt Lake City	Utah	United States
36	Physicians Office Building (POB)	Salt Lake City	Utah	United States
37	McGuire VA Medical Center	Richmond	Virginia	United States
38	Swedish Medical Center	Seattle	Washington	United States
39	Inland Cardiology	Spokane	Washington	United States
40	Marshfield Clinic	Marshfield	Wisconsin	United States
41	St. Joseph's Hospital	Marshfield	Wisconsin	United States
42		Bondi Junction, Cairns, Camperdown, Miranda, Perth		Australia
43	Concord Repartiation General Hospital	Concord		Australia
44		South Australia, Tasmania, Victoria		Australia
45	Cardiology Consultant's Group	Calgary	Alberta	Canada
46	Foothills Medical Centre	Calgary	Alberta	Canada
47	Heart Health Institute	Calgary	Alberta	Canada
48	University of Calgary	Calgary	Alberta	Canada
49	Dr. M.P.J. Senaratne Professional Corporation	Edmonton	Alberta	Canada
50	West Coast Cardiology Research	New Westminster	British Columbia	Canada
51	Cardiac Arrhythmia Trials	Victoria	British Columbia	Canada
52	Health Care Corporation of St. John's Health Sciences Centre	St. John's	Newfoundland and Labrador	Canada
53	Zoom International Inc.	St. Jerome	Quebec	Canada
54	Moose Jaw Cardiac Centre	Moose Jaw	Saskatchewan	Canada
55	Royal University Hospital	Saskatoon	Saskatchewan	Canada
56	Saskatoon Medical Specialists	Saskatoon	Saskatchewan	Canada
57	Specialists Internal Medicine	Saskatoon	Saskatchewan	Canada
58	Dr. Joesph J. Javier	Yorkton	Saskatchewan	Canada
59	Yorkton Regional Health Centre	Yorkton	Saskatchewan	Canada
60		Faaborg, Fredericia, Frederiksberg, Frederikshavn, Hellerup		Denmark
61		Herlev, Hillerod, Holstebro, Horsens, Kalundborg, Kobenhavn		Denmark
62		Kolding, Nykobing Mors, Odense, Skive, Svendborg		Denmark
63		Bourg En Bresse, Dreux, Lille, Marseille, Maubeuge, Mulhouse		France
64		Nantes, Nice, Paris, Poitiers, Rennes, Saint Denis		France
65		Saint-Etienne, Toulouse		France
66	A.O. "Instituti Ospitalieri di Cremona"	Cremona		Italy
67		Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia		Italy
68	Azienda Ospedaliera San Paolo	Milano		Italy
69	Azienda Ospedaliera di Parma	Parma		Italy
70	U.O. di Medicina Interna II	Parma		Italy
71	Centro Emostasi e Trombosi	Rimini		Italy
72		Torino, Treviso		Italy
73		Varese		Italy
74		Almelo, Amersfoort, Breda, Boxmeer, Delft, Dordrecht		Netherlands
75		Eindhoven, Enschede, Gorinchem, Gouda, Groningen, Harderwijk		Netherlands
76		Heerlen, Hilversum, Rotterdam, Sneek, Spijkenisse, Tiel		Netherlands
77	Academisch Ziekenhuis Maastricht	Maastricht		Netherlands
78		Auckland, Christchurch, Hastings		New Zealand
79		Kielce, Krakow, Opole, Plock, Siedlce, Warszawa, Wroclaw		Poland
80	University Hospital of Wales	Cardiff		United Kingdom
81		Exeter, Dundee, Glasgow, Merseyside, Wirral		United Kingdom
82	University of Glasgow	Glasgow		United Kingdom
83	Freeman Hospital	Newscastle Upon Tyne		United Kingdom
84	New Cross Hospital	Wolverhampton		United Kingdom