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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00317395

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 II

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: Eptifibatide Otamixaban Heparin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

Show 36 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided by Sanofi-Aventis

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 - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

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 February 09, 2012