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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	15 July 2013
Main ID:	EUCTR2009-016568-36-IT
Date of registration:	27/04/2010
Prospective Registration:	Yes
Primary sponsor:	sanofi-aventis recherche & de`veloppement
Public title:	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
Scientific title:	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
Date of first enrolment:	04/05/2010
Target sample size:	10930
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016568-36
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Austria	Belgium	Bulgaria	Czech Republic	Estonia	France	Germany	Greece
Hungary	Italy	Latvia	Lithuania	Netherlands	Portugal	Spain	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
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

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. 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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Acute coronary syndrome
MedDRA version: 9.1 Level: LLT Classification code 10051592

Intervention(s)

Product Name: OTAMIXABAN
Product Code: XRP0673
Pharmaceutical Form: Solution for injection
INN or Proposed INN: otamixaban
CAS Number: 219672-50-1
Current Sponsor code: XRP0673
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Product Name: otamixaban
Product Code: XRP0673
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: otamixaban
CAS Number: 219672-50-1
Current Sponsor code: XRP0673
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: INTEGRILIN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Eptifibatide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Trade Name: INTEGRILIN*IV 100ML 0,75MG/ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Eptifibatide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: .75-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: HEPARINE CHOAY 25 000 UI/5 ml
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Heparin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 5000-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To demonstrate the superior efficacy (composite of all-cause death + Myocardial infarction) of otamixaban to unfractionated heparin (UFH) + eptifibatide

Secondary Objective: To demonstrate the superior efficacy ( composite of all-cause death + Myocardial infarction+ any stroke) of otamixaban as compared to UFH + eptifibatide To document the effect of otamixaban on Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH+ eptifibatide To document the effect on mortality (all cause mortality) of otamixaban as compared to UFH+ eptifibatide To document the safety of otamixaban as compared to UFH + eptifibatide To document the effect of otamixaban on Thrombotic procedural complications during the index PCI as compared to UFH + eptifibatide

Primary end point(s): Adjudicated composite of all-cause death and new myocardial infarction (MI) from randomization (Day 1) to Day 7. This endpoint will be analyzed from randomization (Day 1) to Day 30 as a sensitivity analysis

Secondary Outcome(s)

Secondary ID(s)

EFC6204 - TAO

2009-016568-36-HU

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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