Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of Otamixaban With Unfractionated Heparin + Eptifibatide, in Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy

Not Applicable

• Conditions: -I20-I21; I20; I21

• Registration Number: PER-025-10
• Lead Sponsor: sanofi-aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• Patients with Acute Coronary Syndrome without STE segment elevation
• Patients in whom coronary angiography is planned (followed by PCI, when indicated) as soon as possible (after at least 2 hours of treatment with the study medication) and within 36 hours (no later than Day 3 , if justified)
• Informed consent obtained in writing

Exclusion Criteria

• High probability of not being available for follow-up on Day 180
• Age <18 years (or legal age in the country)
• Pregnancy, demonstrated by a positive urine pregnancy test, performed before randomization (applicable only to women with the potential to conceive, that is, premenopausal or postmenopausal women for <2 years)
• Treatment with other investigating agents (including placebo) or devices within 30 days prior to randomization, or planned use of investigating agents or devices during the study
• Breastfeeding
• A revascularization procedure has already been performed for the qualifying event.
• Acute MI with ST segment elevation
• Patients who have received a curative dose of an anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours before randomization.
• Inability to suspend the current anticoagulation to make the transition to Research Products according to the time specified for the transition.
• Patients who cannot be treated with acetylsalicylic acid and clopidogrel (or with any other oral antiplatelet agent) according to their local product information.
• Patients who cannot be treated with eptifibatide according to the national product information (when available). In countries where eptifibatide is not approved, the reference product information to be considered will be the European product information or the product information in the USA (see Appendix H and Appendix I).
• Patients who cannot be treated with unfractionated heparin according to national product information
• Allergy to otamixaban

Study & Design

• Study Type: Interventional
• Study Design: Not specified