A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
Myocardial Infarction, Coronary Disease
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Elective PCI, Heart catherization, Acute coronary syndromes
Eligibility 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.
Sites / Locations
- Ocala Research Institute, Inc.
- University of Chicago - Section of Cardiology
- UMass Memorial Medical Center
- University of Michigan, Dept. of Internal Medicine
- Greenville Hospital System
- Vanderbilt University Medical Center
- The Methodist Hospital
- University of Virginia Health System
- Foothills Hospital
- University of Alberta Hospital
- Vancouver Hospital & Health Sciences Centre
- QE II Health Sciences Centre, New Halifax Infirmary
- HGH-McMaster Clinic
- University of Ottawa Heart Institute
- Sunnybrook & Women's College Health Sciences Center
- St. Michael's Hospital
- Toronto General Hospital
- Montreal Heart Institute
- Hopital du Sacre-Coeur de Montreal
- Hopital Jean Minjoz
- CHU de Caen
- Hopital du Bocage
- CHU de Rangueil
- Centre Hospitalier de Lagny-Marne La Vallee
- Hopital Europeen Georges Pompidou
- Hopital Bichat