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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Otamixaban (XRP0673)
unfractionated heparin
eptifibatide
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Non ST elevation Acute Coronary Syndrome, Early invasive strategy, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Otamixaban Dose 1

Otamixaban Dose 2

Otamixaban Dose 3

Otamixaban Dose 4

Otamixaban Dose 5

UFH/Eptifibatide

Arm Description

dosage regimen 1

dosage regimen 2

dosage regimen 3

dosage regimen 4

dosage regimen 5

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding
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
Incidence of TIMI significant bleeding
Incidence of all bleedings

Full Information

First Posted
April 21, 2006
Last Updated
November 17, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00317395
Brief Title
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
Acronym
SEPIA-ACS1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Non ST elevation Acute Coronary Syndrome, Early invasive strategy, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Otamixaban Dose 1
Arm Type
Experimental
Arm Description
dosage regimen 1
Arm Title
Otamixaban Dose 2
Arm Type
Experimental
Arm Description
dosage regimen 2
Arm Title
Otamixaban Dose 3
Arm Type
Experimental
Arm Description
dosage regimen 3
Arm Title
Otamixaban Dose 4
Arm Type
Experimental
Arm Description
dosage regimen 4
Arm Title
Otamixaban Dose 5
Arm Type
Experimental
Arm Description
dosage regimen 5
Arm Title
UFH/Eptifibatide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Otamixaban (XRP0673)
Intervention Description
intravenous administration
Intervention Type
Drug
Intervention Name(s)
unfractionated heparin
Intervention Description
intravenous administration
Intervention Type
Drug
Intervention Name(s)
eptifibatide
Intervention Description
intravenous administration
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Incidence of TIMI significant bleeding
Time Frame
within 7 days following randomization
Title
Incidence of all bleedings
Time Frame
within 7 days and 30 days following randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Buenos Aires
Country
Argentina
Facility Name
Sanofi-Aventis Administrative Office
City
Vienna
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis Administrative Office
City
Sofia
Country
Bulgaria
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Cali
Country
Colombia
Facility Name
Sanofi-Aventis Administrative Office
City
Zagreb
Country
Croatia
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-Aventis Administrative Office
City
Tatari
Country
Estonia
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Athens
Country
Greece
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Mumbai
Country
India
Facility Name
Sanofi-Aventis Administrative Office
City
Netanya
Country
Israel
Facility Name
Sanofi-Aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Seoul
Country
Korea, Republic of
Facility Name
Sanofi-Aventis Administrative Office
City
Kuala Lumpur
Country
Malaysia
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Singapore
Country
Singapore
Facility Name
Sanofi-Aventis Administrative Office
City
Bratislava
Country
Slovakia
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Geneva
Country
Switzerland
Facility Name
Sanofi-Aventis Administrative Office
City
Taipei
Country
Taiwan
Facility Name
Sanofi-Aventis Administrative Office
City
Bangkok
Country
Thailand
Facility Name
Sanofi-Aventis Administrative Office
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
19717184
Citation
Sabatine MS, Antman EM, Widimsky P, Ebrahim IO, Kiss RG, Saaiman A, Polasek R, Contant CF, McCabe CH, Braunwald E. Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2009 Sep 5;374(9692):787-95. doi: 10.1016/S0140-6736(09)61454-9. Epub 2009 Aug 28. Erratum In: Lancet. 2009 Oct 31;374(9700):1502.
Results Reference
result

Learn more about this trial

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

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