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
- Conditions
- (imminent) Myocardial InfarctionAcute Coronary Syndrome10011082
- Registration Number
- NL-OMON35026
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 145
- Patient with non ST-segment elevation Acute Coronary Syndrome with the following symptoms:
- Ischemic symptoms (chest pain or equivalent) at rest >=10 minutes within 24 hours of randomization
-One of the two following criteria:
*New ST-segment depression >=0.1 mV (>=1 mm), or transient (<30 minutes) ST-segment elevation >=0.1 mV (>=1 mm) in at least 2 contiguous leads on the ECG, OR
*Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal
- Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified)
7.3.1.1 General
- High likelihood of being unavailable for the Day 180 follow up
- Age <18 years old
- Pregnancy, as evidenced by a positive urine pregnancy test performed prior to
randomization (applicable only to women of childbearing potential, ie, women who are
pre-menopausal or <2 years post-menopausal)/ Breastfeeding
- Treatment with other investigational agents (including placebo) or devices within 30 days
prior to randomization, or planned use of investigational agents or devices during the study
duration
- Revascularization procedure already performed for the qualifying event.
- Acute ST-segment elevation MI
- Patient having received curative dose of anticoagulant treatment (including UFH, LMWH,
or bivalirudin) for more than 24 hours prior to randomization.
- Inability to discontinue current anticoagulation in order to transition to Investigational
Products according to the specified transition timing
- Patient who cannot be treated with aspirin and clopidogrel (or any other oral antiplatelet
agent), eptifibatide or UFH according to the national labeling
- Allergy to otamixaban
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>All-cause death + Myocardial infarction from randomization to day 7.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- All-cause death + myocardial infarction + any stroke from randomization to<br /><br>day 7<br /><br>- Rehospitalization or prolongation of hospitalization due to a new episode of<br /><br>myocardial ischemia / myocardial infarction from randomization to day 30<br /><br>- All cause death from randomization to day 30<br /><br>- Safety of otamixaban as compared to UFH + eptifibatide<br /><br>- Procedural thrombotic complications during the index PCI</p><br>