A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN) - Tabular View

Tracking Information
First Received Date ^ICMJE	May 7, 2003
Last Updated Date	November 2, 2009
Start Date ^ICMJE	April 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00060554 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
Official Title ^ICMJE
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Myocardial Infarction Coronary Disease
Intervention ^ICMJE	Drug: fondaparinux sodium Drug: heparin Procedure: percutaneous coronary intervention (PCI)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	300
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, France

Administrative Information
NCT ID ^ICMJE	NCT00060554
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	63133 (ASPIRE-Pilot)
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP