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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
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
Country [16] 0 0
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
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Denmark
State/province [25] 0 0
Herlev, Hillerod, Holstebro, Horsens, Kalundborg, Kobenhavn
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Denmark
State/province [26] 0 0
Kolding, Nykobing Mors, Odense, Skive, Svendborg
Country [27] 0 0
France
State/province [27] 0 0
Bourg En Bresse, Dreux, Lille, Marseille, Maubeuge, Mulhouse
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France
State/province [28] 0 0
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
State/province [31] 0 0
Merate, Milano, Padova, Pavia, Piacenza, Reggio Emilia
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Parma
Country [34] 0 0
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
Country [41] 0 0
New Zealand
State/province [41] 0 0
Auckland, Christchurch, Hastings
Country [42] 0 0
Poland
State/province [42] 0 0
Kielce, Krakow, Opole, Plock, Siedlce, Warszawa, Wroclaw
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Cardiff
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Exeter, Dundee, Glasgow, Merseyside, Wirral
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Glasgow
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Newscastle Upon Tyne
Country [47] 0 0
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/study/NCT00070655
Trial related presentations / publications
Ding WY, Lip GYH, Shantsila A. Relationship between Chronic Kidney Disease, Time-in-Therapeutic Range, and Adverse Outcomes in Atrial Fibrillation: A post hoc Analysis from the AMADEUS Trial. Cerebrovasc Dis. 2022;51(1):29-35. doi: 10.1159/000517608. Epub 2021 Jul 28.
Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.
Amadeus Investigators; Bousser MG, Bouthier J, Buller HR, Cohen AT, Crijns H, Davidson BL, Halperin J, Hankey G, Levy S, Pengo V, Prandoni P, Prins MH, Tomkowski W, Torp-Pedersen C, Wyse DG. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, open-label, non-inferiority trial. Lancet. 2008 Jan 26;371(9609):315-21. doi: 10.1016/S0140-6736(08)60168-3. Erratum In: Lancet. 2008 Dec 13;372(9655):2022.. Thorp-Pedersen, C [corrected to Torp-Pedersen, C].
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/study/NCT00070655