Current partner codePEPTIDESDE
NCT01076764·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

13,220

Locations

607

Results

Not posted

Publications

5

Study summary

What the protocol is testing.

Primary Objective: * To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide Secondary Objectives: * To demonstrate the superior efficacy (composite of all-cause death + MI + 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 death) 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 Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

Full detailed description

Up to the interim analysis, patients are randomized to one of the Otamixaban arms or the control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized to the continued Otamixaban arm (per Data Monitoring Committee (DMC) decision based on interim analysis results) or the control arm (UFH + Eptifibatide). Except the DMC, all participants will remain blinded to this decision until the end of study. The total duration of the study period per subject will range between 30 days and 180 days. Study end date being the Day 30 visit of the last randomized patient, follow up will be until Day 180 or study end date whichever comes first.

Interventions

Treatment arms and agents.

DRUG

Otamixaban

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

Placebo (for Otamixaban)

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

UFH

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

Placebo (for UFH)

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

Eptifibatide

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

DRUG

Placebo (for Eptifibatide)

Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion

Timeline

From registration to results.

  1. First posted

    Feb 26, 2010

  2. Study start

    Apr 2010

  3. Primary completion

    May 2013

  4. Study completion

    May 2013

  5. Results posted

    Not reported

  6. Registry updated

    May 4, 2016

Outcomes

What the study measures.

Primary outcomes

Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction

Time frame · from randomization (day 1) to day 7

Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)

Time frame · from day 1 to day 7

Secondary outcomes

Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke

Time frame · from day 1 to day 7

Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction

Time frame · from day 1 to day 30

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion criteria: Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) 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.

Study locations

607 registered sites.

Argentina · Australia · Austria · Belarus · Belgium · Brazil · Bulgaria · Canada · Chile · Colombia · Croatia · Czechia · Egypt · Estonia · France · Germany · Greece · Hong Kong · Hungary · India · Indonesia · Israel · Italy · Jordan · Latvia · Lebanon · Lithuania · Malaysia · Mexico · Montenegro · Netherlands · New Zealand · North Macedonia · Norway · Panama · Peru · Poland · Portugal · Romania · Russia · Serbia · Singapore · Slovakia · South Africa · South Korea · Spain · Switzerland · Taiwan · Thailand · Tunisia · Turkey (Türkiye) · Ukraine · United Kingdom · United States · Vietnam. Showing up to 24 locations stored in the fast local snapshot.

Investigational Site Number 840015

Huntsville, Alabama, United States

Investigational Site Number 840569

Phoenix, Arizona, United States

Investigational Site Number 840703

Phoenix, Arizona, United States

Investigational Site Number 840101

Anaheim, California, United States

Investigational Site Number 840151

Anaheim, California, United States

Investigational Site Number 840213

Beverly Hills, California, United States

Investigational Site Number 840572

Huntington Beach, California, United States

Investigational Site Number 840201

Long Beach, California, United States

Investigational Site Number 840071

Los Angeles, California, United States

Investigational Site Number 840557

Los Angeles, California, United States

Investigational Site Number 840903

Northridge, California, United States

Investigational Site Number 840065

San Francisco, California, United States

Investigational Site Number 840561

Santa Rosa, California, United States

Investigational Site Number 840721

Littleton, Colorado, United States

Investigational Site Number 840551

Bridgeport, Connecticut, United States

Investigational Site Number 840166

New Haven, Connecticut, United States

Investigational Site Number 840520

Washington D.C., District of Columbia, United States

Investigational Site Number 840185

Fort Lauderdale, Florida, United States

Investigational Site Number 840028

Jacksonville, Florida, United States

Investigational Site Number 840047

Lake Mary, Florida, United States

Investigational Site Number 840500

Melbourne, Florida, United States

Investigational Site Number 840706

Miami, Florida, United States

Investigational Site Number 840009

Ocala, Florida, United States

Investigational Site Number 840146

Ocala, Florida, United States

Publications

Results and literature.

PMID 23194481Steg PG, Mehta SR, Pollack CV Jr, Bode C, Gaudin C, Fanouillere K, Moryusef A, Wiviott SD, Sabatine MS. Design and rationale of the treatment of acute coronary syndromes with otamixaban trial: a double-blind triple-dummy 2-stage randomized trial comparing otamixaban to unfractionated heparin and eptifibatide in non-ST-segment elevation acute coronary syndromes with a planned early invasive strategy. Am Heart J. 2012 Dec;164(6):817-24.e13. doi: 10.1016/j.ahj.2012.10.001. Epub 2012 Nov 7.PMID 23995608Steg PG, Mehta SR, Pollack CV Jr, Bode C, Cohen M, French WJ, Hoekstra J, Rao SV, Ruzyllo W, Ruiz-Nodar JM, Sabate M, Widimsky P, Kiss RG, Navarro Estrada JL, Hod H, Kerkar P, Guneri S, Sezer M, Ruda M, Nicolau JC, Cavallini C, Ebrahim I, Petrov I, Kim JH, Jeong MH, Ramos Lopez GA, Laanmets P, Kovar F, Gaudin C, Fanouillere KC, Minini P, Hoffman EB, Moryusef A, Wiviott SD, Sabatine MS; TAO Investigators. Anticoagulation with otamixaban and ischemic events in non-ST-segment elevation acute coronary syndromes: the TAO randomized clinical trial. JAMA. 2013 Sep 18;310(11):1145-55. doi: 10.1001/jama.2013.277165.PMID 33518473Abtan J, Wiviott SD, Sorbets E, Popovic B, Elbez Y, Mehta SR, Sabatine MS, Bode C, Pollack CV, Cohen M, Moccetti T, Laanmets P, Faxon D, Okreglicki A, Ducrocq G, Steg PG; TAO investigators. Prevalence, clinical determinants and prognostic implications of coronary procedural complications of percutaneous coronary intervention in non-ST-segment elevation myocardial infarction: Insights from the contemporary multinational TAO trial. Arch Cardiovasc Dis. 2021 Mar;114(3):187-196. doi: 10.1016/j.acvd.2020.09.005. Epub 2021 Jan 29.PMID 33430604Dillinger JG, Ducrocq G, Elbez Y, Cohen M, Bode C, Pollack C Jr, Petrauskiene B, Henry P, Dorobantu M, French WJ, Wiviott SD, Sabatine MS, Mehta SR, Steg PG. Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Insights From the TAO Trial. Circ Cardiovasc Interv. 2021 Jan;14(1):e009759. doi: 10.1161/CIRCINTERVENTIONS.120.009759. Epub 2021 Jan 12.PMID 29895599Dillinger JG, Ducrocq G, Elbez Y, Cohen M, Bode C, Pollack C Jr, Nicolau JC, Henry P, Kedev S, Wiviott SD, Sabatine MS, Mehta SR, Steg PG. Activated Clotting Time to Guide Heparin Dosing in Non-ST-Segment-Elevation Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention and Treated With IIb/IIIa Inhibitors: Impact on Ischemic and Bleeding Outcomes: Insights From the TAO Trial. Circ Cardiovasc Interv. 2018 Jun;11(6):e006084. doi: 10.1161/CIRCINTERVENTIONS.118.006084.

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