Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy (TAO)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: Otamixaban (XRP0673) Drug: Otamixaban matching placebo Drug: Unfractionated Heparin Drug: Unfractionated Heparin matching placebo Drug: Eptifibatide Drug: Eptifibatide matching placebo |
Phase 3 |
| 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 |
| Official 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 |
- 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 ]
- 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 ]
| Enrollment: | 13220 |
| Study Start Date: | April 2010 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
|
Drug: Otamixaban (XRP0673)
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
|
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:
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
|
Drug: Otamixaban (XRP0673)
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
|
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:
From PCI (downstream use) until 18-24 hour post PCI or hospital discharge whichever comes first:
|
Drug: Otamixaban matching placebo
Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion Pharmaceutical form: Intravenous (IV) solution Route of administration: IV bolus followed by continuous IV infusion |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Patient with non ST-segment elevation Acute Coronary Syndrome with:
Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization,
AND
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
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
- 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.
Contacts and Locations
Show 607 Study Locations| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01076764 History of Changes |
| Other Study ID Numbers: | EFC6204, 2009-016568-36 |
| Study First Received: | February 25, 2010 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Myocardial Ischemia Angina, Unstable Infarction Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Ischemia Pathologic Processes |
Necrosis Calcium heparin Heparin Eptifibatide Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013