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

Purpose

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	Intervention	Phase
Coronary Disease	Drug: Otamixaban (XRP0673) Drug: unfractionated heparin Drug: eptifibatide	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Coronary Artery Disease Heart Attack

Drug Information available for: Heparin Eptifibatide

U.S. FDA Resources

Further study details as provided by Sanofi:

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 [ Time Frame: within 7 days following randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	3241
Study Start Date:	June 2006
Study Completion Date:	March 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317395

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Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Canada, Quebec
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Colombia
Sanofi-Aventis Administrative Office
Cali, Colombia
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
Estonia
Sanofi-Aventis Administrative Office
Tatari, Estonia
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
India
Sanofi-Aventis Administrative Office
Mumbai, India
Israel
Sanofi-Aventis Administrative Office
Netanya, Israel
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
Slovakia
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Thailand
Sanofi-Aventis Administrative Office
Bangkok, Thailand
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

ICD CSD

Sanofi

More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00317395 History of Changes
Other Study ID Numbers:	DRI6624, XRP0673A/2003
Study First Received:	April 21, 2006
Last Updated:	August 30, 2010
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:

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

Additional relevant MeSH terms:

Coronary Disease
Coronary Artery Disease
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

Calcium heparin
Heparin
Eptifibatide
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013

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