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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
4673
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
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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
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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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
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Denmark
State/province [25] 0 0
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
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Saint-Etienne, Toulouse
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Italy
State/province [30] 0 0
Cremona
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Italy
State/province [31] 0 0
Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
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Italy
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Parma
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Italy
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Rimini
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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
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Maastricht
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New Zealand
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Auckland, Christchurch, Hastings
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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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00070655