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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00317395

Collaborator

(none)

3,241

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Drug: Otamixaban (XRP0673) Drug: unfractionated heparin Drug: eptifibatide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

3241 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

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

Outcome Measures

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 [within 7 days following randomization]

Secondary Outcome Measures

Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleeding [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 [within 30 days, 90 days and 180 days following randomization]
Incidence of TIMI significant bleeding [within 7 days following randomization]
Incidence of all bleedings [within 7 days and 30 days following randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Buenos Aires		Argentina
3	Sanofi-Aventis Administrative Office	Vienna		Austria
4	Sanofi-Aventis Administrative Office	Sao Paulo		Brazil
5	Sanofi-Aventis Administrative Office	Sofia		Bulgaria
6	Sanofi-Aventis Administrative Office	Laval	Quebec	Canada
7	Sanofi-Aventis Administrative Office	Santiago		Chile
8	Sanofi-Aventis Administrative Office	Cali		Colombia
9	Sanofi-Aventis Administrative Office	Zagreb		Croatia
10	Sanofi-Aventis Administrative Office	Praha		Czech Republic
11	Sanofi-Aventis Administrative Office	Horsholm		Denmark
12	Sanofi-Aventis Administrative Office	Tatari		Estonia
13	Sanofi-Aventis Administrative Office	Helsinki		Finland
14	Sanofi-Aventis Administrative Office	Paris		France
15	Sanofi-Aventis Administrative Office	Berlin		Germany
16	Sanofi-Aventis Administrative Office	Athens		Greece
17	Sanofi-Aventis Administrative Office	Budapest		Hungary
18	Sanofi-Aventis Administrative Office	Mumbai		India
19	Sanofi-Aventis Administrative Office	Netanya		Israel
20	Sanofi-Aventis Administrative Office	Milano		Italy
21	Sanofi-Aventis Administrative Office	Seoul		Korea, Republic of
22	Sanofi-Aventis Administrative Office	Kuala Lumpur		Malaysia
23	Sanofi-Aventis Administrative Office	Mexico		Mexico
24	Sanofi-Aventis Administrative Office	Gouda		Netherlands
25	Sanofi-Aventis Administrative Office	Warszawa		Poland
26	Sanofi-Aventis Administrative Office	Porto Salvo		Portugal
27	Sanofi-Aventis Administrative Office	Bucuresti		Romania
28	Sanofi-Aventis Administrative Office	Moscow		Russian Federation
29	Sanofi-Aventis Administrative Office	Singapore		Singapore
30	Sanofi-Aventis Administrative Office	Bratislava		Slovakia
31	Sanofi-Aventis Administrative Office	Midrand		South Africa
32	Sanofi-Aventis Administrative Office	Barcelona		Spain
33	Sanofi-Aventis Administrative Office	Geneva		Switzerland
34	Sanofi-Aventis Administrative Office	Taipei		Taiwan
35	Sanofi-Aventis Administrative Office	Bangkok		Thailand
36	Sanofi-Aventis Administrative Office	Istanbul		Turkey