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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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Medical and Biotech [MESH] Definitions

A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.

Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.

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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