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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00317395 |
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Date of registration:
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21/04/2006 |
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Primary sponsor: |
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Public title:
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Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
SEPIA-ACS1 |
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Scientific title:
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A Randomized, Double-blind, Triple-dummy, Dose-ranging Study, Including an Active Control of Unfractionated Heparin and Eptifibatide, to Evaluate the Clinical Efficacy and Safety of Otamixaban, in Patients With Non-ST Elevation Acute Coronary Syndrome and Planned Early Invasive Strategy |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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3241 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00317395 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Austria
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Brazil
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Bulgaria
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Canada
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Chile
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Colombia
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Croatia
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Czech Republic
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Denmark
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Estonia
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Finland
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France
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Germany
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Greece
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Hungary
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India
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Israel
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Italy
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Korea, Republic of
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Malaysia
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Mexico
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Netherlands
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Poland
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Portugal
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Romania
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Russian Federation
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Singapore
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Slovakia
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South Africa
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Spain
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Switzerland
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Taiwan
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Thailand
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Turkey
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United States
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Venezuela
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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-Aventis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Ischemic discomfort at rest = 10 minutes within 24 hours of randomization
- Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation
(> upper limit of normal [ULN])
- No ST elevation Myocardial Infarction (STEMI)
- Planned coronary angiography followed when indicated by a Percutaneous Coronary
Intervention (PCI) on Day 1 to Day 3
Exclusion Criteria:
- Inability to undergo coronary angiography or PCI by Day 3
- Prior PCI within 30 days
- Acute STEMI
- Cardiogenic shock
- Anticoagulant treatment for > 24 hours prior to randomization
- Prior treatment with fondaparinux since ACS onset
- Requirement for oral anticoagulant (OAC) prior to Day 30
- 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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Coronary Disease
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Intervention(s)
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Drug: eptifibatide
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Drug: Otamixaban (XRP0673)
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Drug: unfractionated heparin
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Primary Outcome(s)
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Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
[Time Frame: within 7 days following randomization]
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Secondary Outcome(s)
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Incidence of all bleedings
[Time Frame: within 7 days and 30 days following randomization]
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Incidence of TIMI significant bleeding
[Time Frame: within 7 days following randomization]
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Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding
[Time Frame: within 7 days and 30 days following randomization]
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Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
[Time Frame: within 30 days, 90 days and 180 days following randomization]
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Secondary ID(s)
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DRI6624
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XRP0673A/2003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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