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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01076764
First received: February 25, 2010
Last updated: May 16, 2013
Last verified: May 2013

February 25, 2010
May 16, 2013
April 2010
May 2013   (final data collection date for primary outcome measure)
  • Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction [ Time Frame: from randomization (day 1) to day 7 ] [ Designated as safety issue: No ]
  • Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor) [ Time Frame: from day 1 to day 7 ] [ Designated as safety issue: Yes ]
  • Efficacy: Adjucated composite of all-cause of death and new myocardial infarction [ Time Frame: from randomization (day 1) to day 7 ] [ Designated as safety issue: No ]
  • Safety: Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor) adjudicated by a blinded Clinical Events Adjudication Committee (CEAC) [ Time Frame: from day 1 to day 7 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01076764 on ClinicalTrials.gov Archive Site
  • Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke [ Time Frame: from day 1 to day 7 ] [ Designated as safety issue: No ]
  • Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction [ Time Frame: from day 1 to day 30 ] [ Designated as safety issue: No ]
  • Adjudicated all-cause death [ Time Frame: from day 1 to day 30 ] [ Designated as safety issue: No ]
  • Adjudicated Procedural thrombotic complications during the index PCI [ Time Frame: during index PCI ] [ Designated as safety issue: No ]
  • Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke [ Time Frame: from day 1 to day 7 ] [ Designated as safety issue: No ]
  • Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction [ Time Frame: from day 1 to day 30 ] [ Designated as safety issue: No ]
  • Adjudicated all-cause death [ Time Frame: from day 1 to day 30 ] [ Designated as safety issue: No ]
  • Procedural thrombotic complications during the index PCI [ Time Frame: during index PCI ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Otamixaban (XRP0673)

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

  • Drug: Otamixaban matching placebo

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

  • Drug: Unfractionated Heparin

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

  • Drug: Unfractionated Heparin matching placebo

    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: Eptifibatide matching placebo

    Pharmaceutical form: Intravenous (IV) solution

    Route of administration: IV bolus followed by continuous IV infusion

  • Experimental: Otamixaban - Dose 1

    From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:

    • Drug A: Otamixaban dose 1
    • Drug B: UFH matching placebo

    From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:

    • Drug C: Eptifibatide matching placebo
    Interventions:
    • Drug: Otamixaban (XRP0673)
    • Drug: Unfractionated Heparin matching placebo
    • Drug: Eptifibatide matching placebo
  • Experimental: Otamixaban - Dose 2

    From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:

    • Drug A: Otamixaban dose 2
    • Drug B: UFH matching placebo

    From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:

    • Drug C: Eptifibatide matching placebo
    Interventions:
    • Drug: Otamixaban (XRP0673)
    • Drug: Unfractionated Heparin matching placebo
    • Drug: Eptifibatide matching placebo
  • Active Comparator: UFH + Eptifibatide

    From randomization until the end of the PCI or, if no PCI, up to Day 4 or hospital discharge whichever comes first:

    • Drug A: Otamixaban matching placebo
    • Drug B: UFH

    From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:

    • Drug C: Eptifibatide
    Interventions:
    • Drug: Otamixaban matching placebo
    • Drug: Unfractionated Heparin
    • Drug: Eptifibatide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13220
May 2013
May 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Belarus,   Canada,   Chile,   Taiwan,   Colombia,   Croatia,   Czech Republic,   Estonia,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Indonesia,   Israel,   Italy,   Jordan,   Korea, Republic of,   Lebanon,   Latvia,   Lithuania,   Malaysia,   Mexico,   Montenegro,   Netherlands,   New Zealand,   Norway,   Panama,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Vietnam,   South Africa,   Spain,   Switzerland,   Thailand,   Tunisia,   Turkey,   Ukraine,   Macedonia, The Former Yugoslav Republic of,   Egypt,   United Kingdom,   United States
 
NCT01076764
EFC6204, 2009-016568-36
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP