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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00070655

Purpose

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	Intervention	Phase
Atrial Fibrillation	Drug: SR34006 (idraparinux sodium) Injection Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners Vitamin K

Drug Information available for: Vitamin K Warfarin Idraparinux sodium SR 34006 Warfarin sodium Acenocoumarol Warfarin potassium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Composite of all strokes and non-CNS systemic embolism.

Secondary Outcome Measures:

Separate components of the primary study outcome.

Enrollment:	4673
Study Start Date:	September 2003
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070655

Show 84 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Amadeus Investigators; Bousser MG, Bouthier J, Büller HR, Cohen AT, Crijns H, Davidson BL, Halperin J, Hankey G, Levy S, Pengo V, Prandoni P, Prins MH, Tomkowski W, Thorp-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.

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00070655 History of Changes
Other Study ID Numbers:	EFC5134, SR34006
Study First Received:	October 6, 2003
Last Updated:	April 5, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Acenocoumarol
Warfarin
Vitamin K
Vitamins
Anticoagulants
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on February 12, 2012