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

• Register: EUCTR
• Last refreshed on: 27 May 2013
• Main ID: EUCTR2009-016568-36-HU
• Date of registration: 02/02/2010
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis recherche & développement
• 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: 10/03/2010
• 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

Countries of recruitment

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

Key inclusion & exclusion criteria

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.
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 scheduled to undergo an early invasive strategy.
MedDRA version: 12.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome

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 bolus use (Noncurrent)

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 drip use (Noncurrent)

Trade Name: INTEGRILIN 2 mg/ml
Product Name: INTEGRILIN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: EPTIFIBATIDE
CAS Number: 188627-80-7
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 bolus use (Noncurrent)

Trade Name: INTEGRILIN 0.75 mg/ml
Product Name: INTEGRILIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: EPTIFIBATIDE
CAS Number: 188627-80-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.75-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous drip use (Noncurrent)

Trade Name: HEPARINE CHOAY 25 000 UI/5 ml
Product Name: HEPARIN SODIUM
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: HEPARIN SODIUM
CAS Number: 01/08/9041
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 5000-
Pharmaceutical form of the placebo: Solution for injection
Route of administration

Primary Outcome(s)

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.

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

Secondary ID(s)

EFC6204