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Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy

2014-07-23 21:09:58 | BioPortfolio

Summary

Primary Objective:

- To demonstrate the superior efficacy (composite of all-cause death + myocardial infarction) of otamixaban to unfractionated heparin (UFH) + eptifibatide

Secondary Objectives:

- To demonstrate the superior efficacy ( composite of all-cause death + Myocardial infarction+ any stroke) of otamixaban as compared to UFH + eptifibatide

- To document the effect of otamixaban on Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH+ eptifibatide

- To document the effect on mortality (all cause mortality) of otamixaban as compared to UFH+ eptifibatide

- To document the safety of otamixaban as compared to UFH + eptifibatide

- To document the effect of otamixaban on Thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

Description

Study end date is the Day 30 visit of the last randomized patient. Follow up will be until the Day 180 (6 Months) phone call or Death or Study end Date whichever comes first.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Acute Coronary Syndrome

Intervention

eptifibatide, unfractionated heparin placebo, unfractionated heparin, otamixaban (XRP0673), eptifibatide placebo, otamixaban placebo

Location

Sanofi-Aventis Investigational Site Number 840015
Huntsville
Alabama
United States
35801

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:58-0400

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The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention

The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coag...

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Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

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PubMed Articles [1144 Associated PubMed Articles listed on BioPortfolio]

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Unfractionated heparin (UFH) is purported to reduce the risk of radial artery occlusion (RAO) after transradial cardiac catheterization. However, the efficacy and optimal dose remain unclear. This met...

Predicting Heparin Responsiveness in Children Before Cardiopulmonary Bypass: A Retrospective Cohort Study.

Inadequate or excess administration of unfractionated heparin for cardiopulmonary bypass (CPB) can cause significant harm. Age-dependent differences in the pharmacodynamics and pharmacokinetics of hep...

Anticoagulation Obtained Below the Arterial Clamp Using a Single Fixed Bolus of Heparin in Vascular Surgery: A Pilot Study.

No clear recommendations exist regarding the optimal dosing of unfractionated heparin (UFH) during vascular surgery. Moreover, little is known about the effect of the UFH bolus downstream of the arter...

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Vascular surgery patients often require anticoagulation with intravenous unfractionated heparin monitored via anti-Xa levels or the activated partial thromboplastin time (aPTT). This study compares th...

Medical and Biotech [MESH] Definitions

Heparin fractions with a molecular weight usually between 4000 and 6000 kD. These low-molecular-weight fractions are effective antithrombotic agents. Their administration reduces the risk of hemorrhage, they have a longer half-life, and their platelet interactions are reduced in comparison to unfractionated heparin. They also provide an effective prophylaxis against postoperative major pulmonary embolism.

Coagulant substances inhibiting the anticoagulant action of heparin.

A heparin fraction with a mean molecular weight of 4500 daltons. It is isolated from porcine mucosal heparin and used as an antithrombotic agent. (From Merck Index, 11th ed)

A group of simple proteins that yield basic amino acids on hydrolysis and that occur combined with nucleic acid in the sperm of fish. Protamines contain very few kinds of amino acids. Protamine sulfate combines with heparin to form a stable inactive complex; it is used to neutralize the anticoagulant action of heparin in the treatment of heparin overdose. (From Merck Index, 11th ed; Martindale, The Extra Pharmacopoeia, 30th ed, p692)

Low-molecular-weight fragment of heparin, having a 4-enopyranosuronate sodium structure at the non-reducing end of the chain. It is prepared by depolymerization of the benzylic ester of porcine mucosal heparin. Therapeutically, it is used as an antithrombotic agent. (From Merck Index, 11th ed)

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