Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome (SEPIA-ACS1)

November 17, 2014 updated by: Sanofi

A Randomized, Double-blind, Triple-dummy, Dose-ranging Study, Including an Active Control of Unfractionated Heparin and Eptifibatide, to Evaluate the Clinical Efficacy and Safety of Otamixaban, in Patients With Non-ST Elevation Acute Coronary Syndrome and Planned Early Invasive Strategy

Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy.

Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3241

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis Administrative Office
  • Austria
      • Vienna, Austria
        • Sanofi-Aventis Administrative Office
  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis Administrative Office
  • Bulgaria
      • Sofia, Bulgaria
        • Sanofi-Aventis Administrative Office
  • Canada
    • Quebec
      • Laval, Quebec, Canada
        • Sanofi-Aventis Administrative Office
  • Chile
      • Santiago, Chile
        • Sanofi-Aventis Administrative Office
  • Colombia
      • Cali, Colombia
        • Sanofi-Aventis Administrative Office
  • Croatia
      • Zagreb, Croatia
        • Sanofi-Aventis Administrative Office
  • Czech Republic
      • Praha, Czech Republic
        • Sanofi-Aventis Administrative Office
  • Denmark
      • Horsholm, Denmark
        • Sanofi-Aventis Administrative Office
  • Estonia
      • Tatari, Estonia
        • Sanofi-Aventis Administrative Office
  • Finland
      • Helsinki, Finland
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Greece
      • Athens, Greece
        • Sanofi-Aventis Administrative Office
  • Hungary
      • Budapest, Hungary
        • Sanofi-Aventis Administrative Office
  • India
      • Mumbai, India
        • Sanofi-Aventis Administrative Office
  • Israel
      • Netanya, Israel
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milano, Italy
        • Sanofi-Aventis Administrative Office
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Sanofi-Aventis Administrative Office
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Sanofi-Aventis Administrative Office
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis Administrative Office
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis Administrative Office
  • Poland
      • Warszawa, Poland
        • Sanofi-Aventis Administrative Office
  • Portugal
      • Porto Salvo, Portugal
        • Sanofi-Aventis Administrative Office
  • Romania
      • Bucuresti, Romania
        • Sanofi-Aventis Administrative Office
  • Russian Federation
      • Moscow, Russian Federation
        • Sanofi-Aventis Administrative Office
  • Singapore
      • Singapore, Singapore
        • Sanofi-Aventis Administrative Office
  • Slovakia
      • Bratislava, Slovakia
        • Sanofi-Aventis Administrative Office
  • South Africa
      • Midrand, South Africa
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • Switzerland
      • Geneva, Switzerland
        • Sanofi-Aventis Administrative Office
  • Taiwan
      • Taipei, Taiwan
        • Sanofi-Aventis Administrative Office
  • Thailand
      • Bangkok, Thailand
        • Sanofi-Aventis Administrative Office
  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ischemic discomfort at rest ≥ 10 minutes within 24 hours of randomization
  • Electrocardiogram (ECG) criteria for non-ST elevation ACS or cardiac enzyme elevation (> upper limit of normal [ULN])
  • No ST elevation Myocardial Infarction (STEMI)
  • Planned coronary angiography followed when indicated by a Percutaneous Coronary Intervention (PCI) on Day 1 to Day 3

Exclusion Criteria:

  • Inability to undergo coronary angiography or PCI by Day 3
  • Prior PCI within 30 days
  • Acute STEMI
  • Cardiogenic shock
  • Anticoagulant treatment for > 24 hours prior to randomization
  • Prior treatment with fondaparinux since ACS onset
  • Requirement for oral anticoagulant (OAC) prior to Day 30
  • Creatinine clearance < 30 ml/min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Otamixaban Dose 1
dosage regimen 1
Drug: Otamixaban (XRP0673)
intravenous administration
Experimental: Otamixaban Dose 2
dosage regimen 2
Drug: Otamixaban (XRP0673)
intravenous administration
Experimental: Otamixaban Dose 3
dosage regimen 3
Drug: Otamixaban (XRP0673)
intravenous administration
Experimental: Otamixaban Dose 4
dosage regimen 4
Drug: Otamixaban (XRP0673)
intravenous administration
Experimental: Otamixaban Dose 5
dosage regimen 5
Drug: Otamixaban (XRP0673)
intravenous administration
Active Comparator: UFH/Eptifibatide
Drug: unfractionated heparin
intravenous administration
Drug: eptifibatide
intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
Time Frame: within 7 days following randomization
within 7 days following randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding
Time Frame: within 7 days and 30 days following randomization
within 7 days and 30 days following randomization
Quadruple efficacy composite of all-cause death, new myocardial infarction, severe recurrent ischemia requiring urgent revascularization and in-hospital bailout use of glycoprotein GPIIb/IIIa inhibitor
Time Frame: within 30 days, 90 days and 180 days following randomization
within 30 days, 90 days and 180 days following randomization
Incidence of TIMI significant bleeding
Time Frame: within 7 days following randomization
within 7 days following randomization
Incidence of all bleedings
Time Frame: within 7 days and 30 days following randomization
within 7 days and 30 days following randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

April 21, 2006

First Submitted That Met QC Criteria

April 21, 2006

First Posted (Estimate)

April 24, 2006

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI6624
  • XRP0673A/2003 (Other Identifier: HMR)
  • 2006-000506-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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