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Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

2014-08-27 03:12:48 | BioPortfolio

Summary

Primary Objective:

- To evaluate cardiovascular outcomes with lixisenatide compared to placebo [composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina] in type 2 diabetic patients who experienced an acute coronary syndrome (ACS) event, at least 5 days and no more than 12 weeks prior to the screening visit.

Secondary Objectives:

- To assess the effect of lixisenatide compared to placebo on:

- composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure

- composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or hospitalization for coronary revascularization procedure

- urinary albumin excretion (based on the urinary albumin/creatinine ratio)

- hemoglobin glycosylated (HbA1c)

- fasting plasma glucose (FPG)

- body weight

- cardiovascular risk markers: high-sensitivity C-reactive protein (hs-CRP), brain natriuretic peptide (BNP), N-terminal prohormone brain natriuretic peptide (NT-proBNPs).

- To assess the safety and tolerability of lixisenatide.

Description

The estimated maximum study treatment duration will be approximately 41 months with about a 27 months of recruitment period.

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

lixisenatide (AVE0010), placebo

Status

Not yet recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:48-0400

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PubMed Articles [12087 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

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An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.

A congenital coronary vessel anomaly in which the left main CORONARY ARTERY originates from the PULMONARY ARTERY instead of from AORTA. The congenital heart defect typically results in coronary artery FISTULA; LEFT-SIDED HEART FAILURE and MITRAL VALVE INSUFFICIENCY during the first months of life.

Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.

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