Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-01 @ 11:35 PM
Study NCT ID:
NCT00317395
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2006-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
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Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2009 Sep 5;374(9692):787-95. doi: 10.1016/S0140-6736(09)61454-9. Epub 2009 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous \\[IV\\] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy.\n\nSecondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic discomfort at rest ≥ 10 minutes within 24 hours of randomization\n* Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation (\\> upper limit of normal \\[ULN\\])\n* No ST elevation Myocardial Infarction (STEMI)\n* Planned coronary angiography followed when indicated by a Percutaneous Coronary Intervention (PCI) on Day 1 to Day 3\n\nExclusion Criteria:\n\n* Inability to 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'OTHER', 'domain': 'HMR'}, {'id': '2006-000506-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Otamixaban Dose 1', 'description': 'dosage regimen 1', 'interventionNames': ['Drug: Otamixaban (XRP0673)']}, {'type': 'EXPERIMENTAL', 'label': 'Otamixaban Dose 2', 'description': 'dosage regimen 2', 'interventionNames': ['Drug: Otamixaban (XRP0673)']}, {'type': 'EXPERIMENTAL', 'label': 'Otamixaban Dose 3', 'description': 'dosage regimen 3', 'interventionNames': ['Drug: Otamixaban (XRP0673)']}, {'type': 'EXPERIMENTAL', 'label': 'Otamixaban Dose 4', 'description': 'dosage regimen 4', 'interventionNames': ['Drug: Otamixaban (XRP0673)']}, {'type': 'EXPERIMENTAL', 'label': 'Otamixaban Dose 5', 'description': 'dosage regimen 5', 'interventionNames': ['Drug: Otamixaban (XRP0673)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'UFH/Eptifibatide', 'interventionNames': ['Drug: unfractionated heparin', 'Drug: eptifibatide']}], 'interventions': 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