A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome event - ELIXA

sanofi-aventis Recherche & Développement0 个研究点目标入组 6,000 人开始时间: 2010年7月16日最近更新: 2015年4月7日

试验速览

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•. Men and women who experienced a spontaneous acute coronary syndrome (ACS) event [i.e., ST-segment elevation myocardial infarction (STEMI)] or non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina (USA)] with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or CK-MB) and the clinical presentation consistent with an acute coronary syndrome which leads to admission to an acute care facility, within 180 days following the ACS event and prior to screening.
•. Patients with a history of type 2 diabetes (for patients newly diagnosed, diagnosis will be based on the World Health Organization (WHO) criteria: i.e., either a fasting venous plasma glucose concentration = 7.0 mmol/L [126 mg/dL] or 2-hour post glucose load venous plasma glucose = 11.1 mmol/L [200 mg/dL], confirmed on 2 occasions) prior to the screening visit.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 3744
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2256

•. Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.
•. HbA1c <5.5 % or >11% measured at screening Visit (1 retest within a week of receipt of the result is permitted with the result of the last sample being decisive).
•. Required to use incretin-based agents (eg, GLP-1 agonists or DPP-4 inhibitors) other than the study drug during the doubleblind treatment period.
•. Patients who have undergone CABG surgery following the qualifying ACS event.
•. Patients who have undergone PCI within 15 days prior to screening.
•. Patients with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit.
•. History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
•. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases.

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