Track topics on Twitter Track topics that are important to you
- 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.
- 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.
The estimated maximum study treatment duration will be approximately 41 months with about a 27 months of recruitment period.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Acute Coronary Syndrome
lixisenatide (AVE0010), placebo
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:12:48-0400
The primary objective of this study is to assess the efficacy of lixisenatide (AVE0010) on a composite endpoint of glycemic control (HbA1c) and body weight in comparison to sitagliptin as ...
The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with metformin in comparison to placebo, over a period of 24 weeks of treatment, followed by an ex...
The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with sulfonylurea without or with metformin in comparison to placebo, over a period of 24 weeks of...
The purpose of this study is to evaluate the benefits and risks of AVE0010 in monotherapy in comparison to placebo, over a period of 12 weeks of treatment. The primary objective is to ass...
The purpose of this study is to evaluate the benefits and risks of AVE0010 in association with pioglitazone with or without metformin in comparison to placebo, over a period of 24 weeks of...
Antithrombotic therapy and other secondary preventive measures such as lifestyle changes, lipid lowering and blood pressure control, along with coronary revascularization strategies, can markedly impr...
To evaluate the impacts of stent techniques on long-term clinical outcomes after percutaneous coronary intervention (PCI) using drug-eluting stents (DES) for coronary bifurcation lesions in patients w...
The objective of this investigation was to determine the etiology of perioperative acute coronary syndrome with a particular emphasis on thrombosis versus demand ischemia.
The atypical presentation of women with acute coronary syndrome (ACS) has been related to delayed diagnosis and treatment, which may explain worse outcome compared with men.
Atherosclerotic in carotids can determinate a poor prognosis in individuals after acute coronary syndrome (ACS). Thus, we aimed to evaluate mortality associated to carotid intima media thickness (CIMT...
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.
Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...