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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00070655




Registration number
NCT00070655
Ethics application status
Date submitted
6/10/2003
Date registered
9/10/2003
Date last updated
6/04/2011

Titles & IDs
Public title
Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation (AMADEUS)
Scientific 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
Secondary ID [1] 0 0
SR34006
Secondary ID [2] 0 0
EFC5134
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR34006 (idraparinux sodium) Injection
Treatment: Drugs - vitamin K antagonist (warfarin or acenocoumarol) tablets

Treatment: Drugs: SR34006 (idraparinux sodium) Injection


Treatment: Drugs: vitamin K antagonist (warfarin or acenocoumarol) tablets


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of all strokes and non-CNS systemic embolism.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Separate components of the primary study outcome.
Timepoint [1] 0 0

Eligibility
Key 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:

1. previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism

2. hypertension requiring drug treatment

3. left ventricular dysfunction (left ventricular ejection fraction <45% or
symptomatic congestive heart failure)

4. age >75 years

5. age between 65-75 years plus diabetes mellitus, or

6. age between 65-75 years plus symptomatic coronary artery disease (previous
myocardial infarction (MI) or angina pectoris)

- Written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bondi Junction, Cairns, Camperdown, Miranda, Perth
Recruitment hospital [2] 0 0
Concord Repartiation General Hospital - Concord
Recruitment hospital [3] 0 0
- South Australia, Tasmania, Victoria
Recruitment postcode(s) [1] 0 0
- Bondi Junction, Cairns, Camperdown, Miranda, Perth
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- South Australia, Tasmania, Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
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United States of America
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Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
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United States of America
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Louisiana
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United States of America
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Massachusetts
Country [9] 0 0
United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Rhode Island
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
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United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Newfoundland and Labrador
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Canada
State/province [23] 0 0
Saskatchewan
Country [24] 0 0
Denmark
State/province [24] 0 0
Faaborg, Fredericia, Frederiksberg, Frederikshavn, Hellerup
Country [25] 0 0
Denmark
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Herlev, Hillerod, Holstebro, Horsens, Kalundborg, Kobenhavn
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Denmark
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Kolding, Nykobing Mors, Odense, Skive, Svendborg
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France
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Bourg En Bresse, Dreux, Lille, Marseille, Maubeuge, Mulhouse
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France
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Nantes, Nice, Paris, Poitiers, Rennes, Saint Denis
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France
State/province [29] 0 0
Saint-Etienne, Toulouse
Country [30] 0 0
Italy
State/province [30] 0 0
Cremona
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Italy
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Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
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Italy
State/province [33] 0 0
Parma
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Italy
State/province [34] 0 0
Rimini
Country [35] 0 0
Italy
State/province [35] 0 0
Torino, Treviso
Country [36] 0 0
Italy
State/province [36] 0 0
Varese
Country [37] 0 0
Netherlands
State/province [37] 0 0
Almelo, Amersfoort, Breda, Boxmeer, Delft, Dordrecht
Country [38] 0 0
Netherlands
State/province [38] 0 0
Eindhoven, Enschede, Gorinchem, Gouda, Groningen, Harderwijk
Country [39] 0 0
Netherlands
State/province [39] 0 0
Heerlen, Hilversum, Rotterdam, Sneek, Spijkenisse, Tiel
Country [40] 0 0
Netherlands
State/province [40] 0 0
Maastricht
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New Zealand
State/province [41] 0 0
Auckland, Christchurch, Hastings
Country [42] 0 0
Poland
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Kielce, Krakow, Opole, Plock, Siedlce, Warszawa, Wroclaw
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United Kingdom
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Cardiff
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United Kingdom
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Exeter, Dundee, Glasgow, Merseyside, Wirral
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United Kingdom
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Glasgow
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United Kingdom
State/province [46] 0 0
Newscastle Upon Tyne
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United Kingdom
State/province [47] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00070655
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications