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A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI) Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI) Clinical research trials and A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI) healthcare trials happen in a lot of of localities across the United States of America. 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 / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI). A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI) Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive 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 fondaparinux in percutaneous coronary intervention (PCI) clinical trial. Human subjects often receive the most effective healthcare possible for their A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI) condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI) A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI)
A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI)
For Condition: Coronary Disease,Myocardial Infarction
Status: Completed
Sponsor(s): Organon ,
Synopsis: The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria - Scheduled for PCI, including PCI for non-ST elevation acute coronary syndromes (ACS), primary PCI for ST elevation myocardial infarction (MI) or elective PCI (with planned overnight stay in hospital). (Patients undergoing diagnostic heart catherization who are suitable candidates for "ad hoc" PCI are also eligible). Exclusion criteria: - Age < 21 years - Activated Clotting Time (ACT) > 200 seconds immediately prior to PCI - Use of low molecular weight heparin (LMWH) in the previous 6 hours before PCI - Currently receiving an oral anticoagulant (OAC) agent with an INR > 1.8 - Thrombolytic therapy for ST elevation MI in the previous 24 hours before PCI - Active internal bleeding or history of hemorrhagic diathesis - Thrombocytopenia (platelet count < 100 x 10-9/L) - Pregnant women or women of childbearing potential who are not using an effective method of contraception - Known allergy to unfractionated heparin, fondaparinux, aspirin or clopidogrel - Absolute contra-indication to anticoagulation - Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment or prior participation in this study.
Total Enrollment: 300
Location and Contact Information:
CHU de Rangueil
Toulouse, Cedex, 31043
France
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
University of Chicago - Section of Cardiology
Chicago, Illinois, 60637
United States
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
The Methodist Hospital
Houston, Texas, 77030
United States
CHU de Caen
Caen, Cedex, 14033
France
Ocala Research Institute, Inc.
Ocala, Florida, 34480
United States
QE II Health Sciences Centre, New Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7
Canada
Hopital Bichat
Paris, , 75018
France
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Canada
Foothills Hospital
Calgary, Alberta, T2N 2T9
Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Canada
Hopital Europeen Georges Pompidou
Paris, , 75015
France
Vancouver Hospital & Health Sciences Centre
Vancouver, British Columbia, V5Z 1M9
Canada
Greenville Hospital System
Greenville, South Carolina, 29605
United States
Hopital Jean Minjoz
Besancon, Cedex, 25030
France
Hopital du Bocage
Dijon, Cedex, 21034
France
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Canada
Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario, M4N 3M5
Canada
HGH-McMaster Clinic
Hamilton, Ontario, L81 2X2
Canada
Centre Hospitalier de Lagny-Marne La Vallee
Lagny, sur Marne, 77405
France
University of Michigan, Dept. of Internal Medicine
Ann Arbor, Michigan, 48109
United States
University of Alberta Hospital
Edmonton, Alberta, T6G 2R7
Canada
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Additional Information:
Study ID Numbers: 63133 (ASPIRE-Pilot);
Study Start Date: April 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060554
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A safety and efficacy trial evaluating the use of fondaparinux in percutaneous coronary intervention (PCI)
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