Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01076764
• Date of registration: 25/02/2010
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing 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
• Date of first enrolment: April 2010
• Target sample size: 13220
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01076764
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jordan, Korea, Republic of, Latvia, Lebanon, Lithuania, Macedonia, The Former Yugoslav Republic of, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United States, Vietnam

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

Patient with non ST-segment elevation Acute Coronary Syndrome with:

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

AND

2. 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
electrocardiogram,

- 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

3. 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

4. Informed consent obtained in writing.

Exclusion criteria:

- 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 or who have been
treated by abciximab.

- Inability to discontinue current anticoagulation in order to transition to
Investigational Products according to the specified transition timing.

- Patient who can not be treated by aspirin and clopidogrel (or any other oral
antiplatelet agent) according to their local labeling.

- 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 is either the European labeling or the US labeling

- Patient who cannot be treated with unfractionated heparin according to the national
labeling.

- Allergy to otamixaban.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome

Intervention(s)

Drug: Otamixaban (XRP0673)

Drug: Unfractionated Heparin matching placebo

Drug: Eptifibatide

Drug: Eptifibatide matching placebo

Drug: Unfractionated Heparin

Drug: Otamixaban matching placebo

Primary Outcome(s)

Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor) [Time Frame: from day 1 to day 7]

Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction [Time Frame: from randomization (day 1) to day 7]

Secondary Outcome(s)

Adjudicated all-cause death [Time Frame: from day 1 to day 30]

Adjudicated Procedural thrombotic complications during the index PCI [Time Frame: during index PCI]

Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction [Time Frame: from day 1 to day 30]

Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke [Time Frame: from day 1 to day 7]

Secondary ID(s)

2009-016568-36

EFC6204

Source(s) of Monetary Support

Please refer to primary and secondary sponsors