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A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation Clinical research trials and A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation. A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation  A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation
A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation
For Condition: Atrial Fibrillation
Status: Recruiting
Sponsor(s): Organon ,
Synopsis: 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, SanOrg34006 (International Nonproprietary Name - idraparinux sodium), with warfarin or acenocoumarol tablets. Assignment to either SanOrg34006 (idraparinux sodium) Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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: (a.) previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism (b.) hypertension requiring drug treatment (c.) left ventricular dysfunction (left ventricular ejection fraction <45% or symptomatic congestive heart failure) (d.) age >75 years (e.) age between 65-75 years plus diabetes mellitus, or (f.) 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 - Any other contraindication listed in the labeling of warfarin or acenocoumarol
Total Enrollment:
Location and Contact Information:
The Clinic (Lake Charles Medical & Surgical Clinic) *Recruiting*
Lake Charles, Louisiana,
United States
Recruiting
Health Care Corporation of St. John's Health Sciences Centre *Recruiting*
St. John's, Newfoundland and Labrador,
Canada
Recruiting
South Texas Cardiovascular Consultants *Recruiting*
San Antonio, Texas,
United States
Recruiting
Beacon Medical Research *Recruiting*
Indianapolis, Indiana,
United States
Recruiting
Cardiology Consultant's Group *Recruiting*
Calgary, Alberta,
Canada
Recruiting
Marshfield Clinic *Recruiting*
Marshfield, Wisconsin,
United States
Recruiting
Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates *Recruiting*
Dallas, Texas,
United States
Recruiting
Blackstone Cardiology Associates, P.C. *Recruiting*
Pawtucket, Rhode Island,
United States
Recruiting
Jerry L. Pettis VA Medical Center *Recruiting*
Loma Linda, California,
United States
Recruiting
Denver Health and Hospital Authority Eastside Health Clinic *Recruiting*
Denver, Colorado,
United States
Recruiting
Duke University Medical Center *Recruiting*
Durham, North Carolina,
United States
Recruiting
Saskatoon Medical Specialists *Recruiting*
Saskatoon, Saskatchewan,
Canada
Recruiting
Jacksonville Center for Clinical Research *Recruiting*
Jacksonville, Florida,
United States
Recruiting
Moose Jaw Cardiac Centre *Recruiting*
Moose Jaw, Saskatchewan,
Canada
Recruiting
Richard A. Levy, M.D. *Recruiting*
San Francisco, California,
United States
Recruiting
Physicians Office Building (POB) *Recruiting*
Salt Lake City, Utah,
United States
Recruiting
Heart & Vascular Clinic/Advanced Medical Research *Recruiting*
Covington, Louisiana,
United States
Recruiting
Wellington Green Family Practice *Recruiting*
Wellington, Florida,
United States
Recruiting
Baystate Medical Center *Recruiting*
Springfield, Massachusetts,
United States
Recruiting
Inland Cardiology *Recruiting*
Spokane, Washington,
United States
Recruiting
St. Joseph's Hospital *Recruiting*
Marshfield, Wisconsin,
United States
Recruiting
North Broward Hospital District Cardiovascular Research Institute *Recruiting*
Ft. Lauderdale, Florida,
United States
Recruiting
IMG Healthcare, LLC *Recruiting*
New Orleans, Louisiana,
United States
Recruiting
Dr. Joesph J. Javier *Recruiting*
Yorkton, Saskatchewan,
Canada
Recruiting
New Mexico Heart Institute, PA *Recruiting*
Albuquerque, New Mexico,
United States
Recruiting
Yorkton Regional Health Centre *Recruiting*
Yorkton, Saskatchewan,
Canada
Recruiting
Cardiology, P.C. *Recruiting*
Birmingham, Alabama,
United States
Recruiting
West Coast Cardiology Research *Recruiting*
New Westminster, British Columbia,
Canada
Recruiting
Cardiovascular Center of Sarasota *Recruiting*
Sarasota, Florida,
United States
Recruiting
University of New Mexico Hospital *Recruiting*
Albuquerque, New Mexico,
United States
Recruiting
Aurora Denver Cardiology Associates *Recruiting*
Aurora, Colorado,
United States
Recruiting
Kenneth W. Carr, M.D. Cardiology *Recruiting*
Oceanside, California,
United States
Recruiting
Zoom International Inc. *Recruiting*
St. Jerome, Quebec,
Canada
Recruiting
Cardiac Arrhythmia Trials *Recruiting*
Victoria, British Columbia,
Canada
Recruiting
Saguaro Clinical Research *Recruiting*
Tucson, Arizona,
United States
Recruiting
Denver Health Medical Center *Recruiting*
Denver, Colorado,
United States
Recruiting
Arizona Heart Institute Mesa *Recruiting*
Mesa, Arizona,
United States
Recruiting
Oracle Research, a Division of: The Heart Center, P.C. *Recruiting*
Huntsville, Alabama,
United States
Recruiting
Denver Health and Hospital Authority Adult Medicine Clinic *Recruiting*
Denver, Colorado,
United States
Recruiting
Specialists Internal Medicine *Recruiting*
Saskatoon, Saskatchewan,
Canada
Recruiting
Office of Dr. Bowden, D.O. *Recruiting*
Healdsburg, California,
United States
Recruiting
LDS Hospital *Recruiting*
Salt Lake City, Utah,
United States
Recruiting
Jacksonville Cardiovascular Clinic *Recruiting*
Jacksonville, Florida,
United States
Recruiting
The Oregon Health and Science University *Recruiting*
Portland, Oregon,
United States
Recruiting
Austin Heart, P.A. *Recruiting*
Austin, Texas,
United States
Recruiting
Heart Health Institute *Recruiting*
Calgary, Alberta,
Canada
Recruiting
Florida Arrhythmia Consultants *Recruiting*
Ft. Lauderdale, Florida,
United States
Recruiting
Practice of James A. Underberg @ Murray Hill Medical Group *Recruiting*
New York City, New York,
United States
Recruiting
Cardiology Specialists of Orange County *Recruiting*
Santa Ana, California,
United States
Recruiting
Dr. M.P.J. Senaratne Professional Corporation *Recruiting*
Edmonton, Alberta,
Canada
Recruiting
Additional Information:
Study ID Numbers: 64720;
Study Start Date: September 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070655
Other Atrial Fibrillation Studies:
1. Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)
2. Compare the effects of amiodarone, sotalol, and placebo in maintaining sinus rhythm in patients with atrial fibrillation converted to sinus rhythm
3. A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation
4. Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial
5. Efficacy and Safety Evaluation of Azimilide or Sotalol vs placebo for Treatment of Patients With Atrial Fibrillation.
Related Studies:
Other Atrial Fibrillation Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
A safety and efficacy trial evaluating the use of SanOrg34006 compared to warfarin or acenocoumarol in patients with atrial fibrillation
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