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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00317395
First received: April 21, 2006
Last updated: August 30, 2010
Last verified: August 2010

April 21, 2006
August 30, 2010
June 2006
October 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Quadruple efficacy composite of all-cause death, new myocardial infarction (MI), severe recurrent ischemia requiring urgent revascularization and in-hospital bailout,use of GPIIb/IIIa inhibitor within 7 days following randomization
Complete list of historical versions of study NCT00317395 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of TIMI significant bleeding [ Time Frame: within 7 days following randomization ] [ Designated as safety issue: Yes ]
  • Incidence of all bleedings [ Time Frame: within 7 days and 30 days following randomization ] [ Designated as safety issue: Yes ]
  • Net clinical benefit: composite of the primary efficacy end point and TIMI significant bleeding at D7 and D30
  • Primary efficacy end point at D30, D90 and D180
  • Safety: TIMI significant bleeding, all bleedings, all AE and SAE at D7 and D30.
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Coronary Disease
  • Drug: Otamixaban (XRP0673)
    intravenous administration
  • Drug: unfractionated heparin
    intravenous administration
  • Drug: eptifibatide
    intravenous administration
  • Experimental: Otamixaban Dose 1
    dosage regimen 1
    Intervention: Drug: Otamixaban (XRP0673)
  • Experimental: Otamixaban Dose 2
    dosage regimen 2
    Intervention: Drug: Otamixaban (XRP0673)
  • Experimental: Otamixaban Dose 3
    dosage regimen 3
    Intervention: Drug: Otamixaban (XRP0673)
  • Experimental: Otamixaban Dose 4
    dosage regimen 4
    Intervention: Drug: Otamixaban (XRP0673)
  • Experimental: Otamixaban Dose 5
    dosage regimen 5
    Intervention: Drug: Otamixaban (XRP0673)
  • Active Comparator: UFH/Eptifibatide
    Interventions:
    • Drug: unfractionated heparin
    • Drug: eptifibatide
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. Epub 2009 Aug 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3241
March 2009
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Austria,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey
 
NCT00317395
DRI6624, XRP0673A/2003
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP