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

Sponsored by:	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-STE 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 (XRP0673A) Drug: unfractionated heparin Drug: eptifibatide	Phase II

MedlinePlus related topics: Blood Thinners Coronary Artery Disease Heart Attack

Drug Information available for: Heparin Eptifibatide Otamixaban

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Quadruple efficacy composite of all-cause death, new myocardial infarction (MI), 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: at Day 7 (D7) and D30 ] [ Designated as safety issue: No ]
Same as primary efficacy end point but at different timepoints [ Time Frame: at D30, D90 and D180 ] [ Designated as safety issue: No ]
Safety: TIMI significant bleeding, all bleedings, all adverse events (AE) and serious adverse events (SAE) [ Time Frame: at D7 and D30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3240
Study Start Date:	October 2006
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dosage regimen 1	Drug: Otamixaban (XRP0673A) intravenous administration
2: Experimental dosage regimen 2	Drug: Otamixaban (XRP0673A) intravenous administration
3: Experimental dosage regimen 3	Drug: Otamixaban (XRP0673A) intravenous administration
4: Experimental dosage regimen 4	Drug: Otamixaban (XRP0673A) intravenous administration
5: Experimental dosage regimen 5	Drug: Otamixaban (XRP0673A) intravenous administration
6: Active Comparator	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 acute coronary syndrome (NSTE 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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DRI6624, XRP0673A/2003
Study First Received:	April 21, 2006
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00317395
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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Heparin, Low-Molecular-Weight
Vascular Diseases
Ischemia
Arteriosclerosis

Calcium heparin
Coronary Disease
Acute Coronary Syndrome
Eptifibatide
Heparin
Coronary Artery Disease

Additional relevant MeSH terms:

Disease
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

Fibrin Modulating Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009