FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00317395
Acronym
SEPIA-ACS1
Enrollment
3241
Registered
2006-04-24
Start date
2006-06-30
Completion date
2009-03-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

Non ST elevation Acute Coronary Syndrome, Early invasive strategy, Percutaneous Coronary Intervention

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).

Interventions

DRUGOtamixaban (XRP0673)

intravenous administration

DRUGunfractionated heparin

intravenous administration

DRUGeptifibatide

intravenous administration

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 inhibitorwithin 7 days following randomization

Secondary

MeasureTime frame
Net clinical benefit: composite of the primary efficacy end point and Thrombolysis in Myocardial Infarction (TIMI) significant bleedingwithin 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 inhibitorwithin 30 days, 90 days and 180 days following randomization
Incidence of TIMI significant bleedingwithin 7 days following randomization
Incidence of all bleedingswithin 7 days and 30 days following randomization

Countries

Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026