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

Phase 1

• Conditions: Acute coronary syndrome scheduled to undergo an early invasive strategy.; MedDRA version: 12.1Level: LLTClassification code 10051592Term: Acute coronary syndrome

• Registration Number: EUCTR2009-016568-36-SK
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-04
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13220

Inclusion Criteria

Patient with non ST-segment elevation Acute Coronary Syndrome with the following symptoms:

I 01. Ischemic symptoms (chest pain or equivalent) at rest =10 minutes within 24 hours of randomization

AND
I 02.One of the two following criteria:
I 02A. 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
I 02B. 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

AND
I 03. 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)

AND
I 04. Informed consent obtained in writing

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

Exclusion Criteria

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, or who have been treated by fondaparinux or abciximab.
E 09. Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing

Exclusion criteria related to the active comparator and/or mandatory background therapies

Related to mandatory background therapies
E 10. Patients who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling

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

Exclusion criteria related to the current knowledge of a sanofi-aventis compound
E 13. Allergy to otamixaban

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified