Atrial Fibrillation Clinical Trial
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
| Verified date | April 2011 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 4673 |
| Est. completion date | March 2006 |
| Est. primary completion date | March 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Concord Repartiation General Hospital | Concord | |
| Canada | Cardiology Consultant's Group | Calgary | Alberta |
| Canada | Foothills Medical Centre | Calgary | Alberta |
| Canada | Heart Health Institute | Calgary | Alberta |
| Canada | University of Calgary | Calgary | Alberta |
| Canada | Dr. M.P.J. Senaratne Professional Corporation | Edmonton | Alberta |
| Canada | Moose Jaw Cardiac Centre | Moose Jaw | Saskatchewan |
| Canada | West Coast Cardiology Research | New Westminster | British Columbia |
| Canada | Royal University Hospital | Saskatoon | Saskatchewan |
| Canada | Saskatoon Medical Specialists | Saskatoon | Saskatchewan |
| Canada | Specialists Internal Medicine | Saskatoon | Saskatchewan |
| Canada | Zoom International Inc. | St. Jerome | Quebec |
| Canada | Health Care Corporation of St. John's Health Sciences Centre | St. John's | Newfoundland and Labrador |
| Canada | Cardiac Arrhythmia Trials | Victoria | British Columbia |
| Canada | Dr. Joesph J. Javier | Yorkton | Saskatchewan |
| Canada | Yorkton Regional Health Centre | Yorkton | Saskatchewan |
| Italy | A.O. "Instituti Ospitalieri di Cremona" | Cremona | |
| Italy | Azienda Ospedaliera San Paolo | Milano | |
| Italy | Azienda Ospedaliera di Parma | Parma | |
| Italy | U.O. di Medicina Interna II | Parma | |
| Italy | Centro Emostasi e Trombosi | Rimini | |
| Netherlands | Academisch Ziekenhuis Maastricht | Maastricht | |
| United Kingdom | University Hospital of Wales | Cardiff | |
| United Kingdom | University of Glasgow | Glasgow | |
| United Kingdom | Freeman Hospital | Newscastle Upon Tyne | |
| United Kingdom | New Cross Hospital | Wolverhampton | |
| United States | New Mexico Heart Institute, PA | Albuquerque | New Mexico |
| United States | University of New Mexico Hospital | Albuquerque | New Mexico |
| United States | Aurora Denver Cardiology Associates | Aurora | Colorado |
| United States | Austin Heart, P.A. | Austin | Texas |
| United States | Cardiology, P.C. | Birmingham | Alabama |
| United States | Heart & Vascular Clinic/Advanced Medical Research | Covington | Louisiana |
| United States | Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates | Dallas | Texas |
| United States | Denver Health and Hospital Authority Adult Medicine Clinic | Denver | Colorado |
| United States | Denver Health and Hospital Authority Eastside Health Clinic | Denver | Colorado |
| United States | Denver Health Medical Center | Denver | Colorado |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Florida Arrhythmia Consultants | Fort Lauderdale | Florida |
| United States | North Broward Hospital District Cardiovascular Research Institute | Fort Lauderdale | Florida |
| United States | Office of Dr. Bowden, D.O. | Healdsburg | California |
| United States | Oracle Research, a Division of: The Heart Center, P.C. | Huntsville | Alabama |
| United States | Beacon Medical Research | Indianapolis | Indiana |
| United States | Jacksonville Cardiovascular Clinic | Jacksonville | Florida |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | The Clinic (Lake Charles Medical & Surgical Clinic) | Lake Charles | Louisiana |
| United States | Jerry L. Pettis VA Medical Center | Loma Linda | California |
| United States | Marshfield Clinic | Marshfield | Wisconsin |
| United States | St. Joseph's Hospital | Marshfield | Wisconsin |
| United States | Arizona Heart Institute Mesa | Mesa | Arizona |
| United States | IMG Healthcare, LLC | New Orleans | Louisiana |
| United States | Practice of James A. Underberg @ Murray Hill Medical Group | New York | New York |
| United States | Kenneth W. Carr, M.D. Cardiology | Oceanside | California |
| United States | Blackstone Cardiology Associates, P.C. | Pawtucket | Rhode Island |
| United States | The Oregon Health and Science University | Portland | Oregon |
| United States | McGuire VA Medical Center | Richmond | Virginia |
| United States | LDS Hospital | Salt Lake City | Utah |
| United States | Physicians Office Building (POB) | Salt Lake City | Utah |
| United States | South Texas Cardiovascular Consultants | San Antonio | Texas |
| United States | Richard A. Levy, M.D. | San Francisco | California |
| United States | Cardiology Specialists of Orange County | Santa Ana | California |
| United States | Cardiovascular Center of Sarasota | Sarasota | Florida |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | Inland Cardiology | Spokane | Washington |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | Saguaro Clinical Research | Tucson | Arizona |
| United States | Southern Arizona Veterans Affairs Health Care System | Tucson | Arizona |
| United States | Wellington Green Family Practice | Wellington | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States, Australia, Canada, Denmark, France, Italy, Netherlands, New Zealand, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite of all strokes and non-CNS systemic embolism. | |||
| Secondary | Separate components of the primary study outcome. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
| Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
| Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
| Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
| Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
| Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
| Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
| Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
| Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
| Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
| Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
| Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
| Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
| Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
| Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
| Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
| Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
| Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
| Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |