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 - TAO
- Conditions
- Acute coronary syndromeMedDRA version: 9.1Level: LLTClassification code 10051592
- Registration Number
- EUCTR2009-016568-36-IT
- Lead Sponsor
- sanofi-aventis recherche & de`veloppement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10930
Pazienti con sindrome coronarica acuta senza sopraslivellamento del tratto ST, che presentino sintomi di ischemia cardiaca: I 01. Dolore toracico o equivalente comparso a riposo, con una durata > 10 minuti nelle 24 ore precedenti la randomizzazione E I 02. uno dei seguenti criteri I02A Nuovo sottoslivellamento del tratto ST > 0,1 mV (> 1 mm), oppure un sopraslivellamento transitorio (< 30 minuti) del tratto ST > 0,1 mV (> 1 mm) in almeno due derivazioni contigue del tracciato elettrocardiografico, OPPURE I02B Aumento degli enzimi cardiaci nelle 24 ore precedenti la randomizzazione: troponina T, troponina I oppure CK-MB al di sopra dei limiti superiori di normalita`. E I 03. Angiografia coronarica programmata seguita, se necessario, da procedura di rivascolarizzazione (PCI) da effettuarsi appena possibile (dopo almeno due ore di trattamento con il farmaco in studio) ed entro le 36 ore (al piu` tardi al giorno 3, se clinicamente giustificato). E I 04. consenso informato scritto firmato dal paziente
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Cardiovascular E 06. Revascularization procedure already performed for the qualifying event. E 07. Acute ST-segment elevation MI Related to prior or concomitant treatments E 08. Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization. E 09. Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing E 10. Patients who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling Exclusion criteria related to the active comparator and/or mandatory background therapies Related to eptifibatide E 11. Patient who cannot be treated with eptifibatide according to the national labeling (when available).In countries where eptifibatide is not approved the reference label to be considered will be either the European labeling or the US labeling. Related to unfractionated heparin E 12. Patient who cannot be treated with unfractionated heparin according to the national labeling Related to otamixaban E 13. Allergy to otamixaban
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method