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

Tracking Information

First Received Date ^ICMJE

October 6, 2003

Last Updated Date

April 28, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Composite of all strokes and non-CNS systemic embolism.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00070655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Separate components of the primary study outcome.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Safety/Efficacy Study

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: SR34006 (idraparinux sodium) Injection
Drug: vitamin K antagonist (warfarin or acenocoumarol) tablets

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada, Denmark, France, Italy, Netherlands, New Zealand, Poland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00070655

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

EFC5134, SR34006

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP