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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00060554 |
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Date of registration:
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07/05/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
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Scientific title:
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Date of first enrolment:
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April 2003 |
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Target sample size:
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300 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00060554 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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France
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myocardial Infarction
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Coronary Disease
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Intervention(s)
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Drug: heparin
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Procedure: percutaneous coronary intervention (PCI)
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Drug: fondaparinux sodium
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Secondary ID(s)
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63133 (ASPIRE-Pilot)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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