A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
Withdrawn before enrolling · Phase 2
Conditions studied: Myocardial Infarction, Coronary Disease
In brief
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.
Key facts
- Study ID
- NCT00060554
- Run by
- Schering-Plough
- People needed
- 300
- Starts
- 2003-04-01
- Last updated by the study team
- 2009-11-03
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Ocala Research Institute, Inc. — Ocala, Florida, United States
- University of Chicago - Section of Cardiology — Chicago, Illinois, United States
- UMass Memorial Medical Center — Worcester, Massachusetts, United States
- University of Michigan, Dept. of Internal Medicine — Ann Arbor, Michigan, United States
- Greenville Hospital System — Greenville, South Carolina, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- The Methodist Hospital — Houston, Texas, United States
- University of Virginia Health System — Charlottesville, Virginia, United States
- Foothills Hospital — Calgary, Alberta, Canada
- University of Alberta Hospital — Edmonton, Alberta, Canada
- Vancouver Hospital & Health Sciences Centre — Vancouver, British Columbia, Canada
- QE II Health Sciences Centre, New Halifax Infirmary — Halifax, Nova Scotia, Canada
- HGH-McMaster Clinic — Hamilton, Ontario, Canada
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada
- Sunnybrook & Women's College Health Sciences Center — Toronto, Ontario, Canada
- St. Michael's Hospital — Toronto, Ontario, Canada
- Toronto General Hospital — Toronto, Ontario, Canada
- Montreal Heart Institute — Montreal, Quebec, Canada
- Hopital du Sacre-Coeur de Montreal — Montreal, Quebec, Canada
- Hopital Jean Minjoz — Besançon, Cedex, France
- CHU de Caen — Caen, Cedex, France
- Hopital du Bocage — Dijon, Cedex, France
- CHU de Rangueil — Toulouse, Cedex, France
- Centre Hospitalier de Lagny-Marne La Vallee — Lagny, Sur Marne, France
- Hopital Europeen Georges Pompidou — Paris, France
Full record on ClinicalTrials.gov
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