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Completed

NCT Number: NCT00317395

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

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).

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTAMIXABAN (XRP0673)

Drug

intravenous administration

Unfractionated heparin

Drug

intravenous administration

Eptifibatide

Drug

intravenous administration

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Incidence of TIMI significant bleeding

    Time frame: within 7 days following randomization

  4. Incidence of all bleedings

    Time frame: within 7 days and 30 days following randomization

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: SEPIA-ACS1

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Apr 24, 2006
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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