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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: |
NCT00133731 |
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Date of registration:
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23/08/2005 |
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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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The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
SEPIA-PCI |
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Scientific title:
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A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin, in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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947 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00133731 |
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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 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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Belgium
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Canada
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Czech Republic
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France
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Germany
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Netherlands
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Slovakia
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South Africa
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Spain
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United States
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Contacts
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Name:
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ICD CSD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years of age or older
- Due to undergo non-urgent percutaneous coronary intervention (PCI)
- Planned treatment with aspirin and clopidogrel
Exclusion Criteria:
- Recent acute coronary syndrome
- Patients at risk for, or with prior recent, bleeding
- Patients have received recent prior treatment with an anticoagulant
- Creatinine clearance > 30 ml/min
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Angioplasty, Transluminal, Percutaneous Coronary
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Intervention(s)
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Drug: Unfractionated Heparin
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Drug: Otamixaban (XRP0673)
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Procedure: Percutaneous Coronary Intervention
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Primary Outcome(s)
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Death, myocardial infarction, and urgent and non-urgent target vessel revascularization
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Secondary Outcome(s)
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Bleeding events
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Secondary ID(s)
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XRP0673
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DRI6199
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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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