Featured Clinical Trial:

Type 2 Diabetes after Acute Coronary Syndrome (product/compound: lixisenatide)

ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside

Status:
Open for enrollment (accepting patients). Please contact us and mention Trial ID NCT01147250.

Condition: Acute Coronary Syndrome

Product Name/Compound: lixisenatide (AVE0010)

Full Study Title: 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

Study Summary: * 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 a spontaneous, biomarker-positive acute coronary syndrome (ACS) event, at least 5 days and no more than 90 days prior to the screening visit.

Eligible Participants:

Inclusion (Eligible):

• Men and women >= 30 years of age
• 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), at least 5 days and no more than 90 days prior to the screening visit, and providing that they are discharged from the acute care facility (i.e., emergency room, intensive care unit, etc).
• 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.

Exclusion (Not Eligible):

• For the entry into the run-in period:
  • glycated hemoglobin A1c (HbA1c) < 6.0% or > 10.0% on last value obtained prior to the screening visit
  • fasting plasma glucose > 13.9 mmol/L (> 250 mg/dL), on last value obtained prior to the screening visit.
  • patients who have undergone a coronary artery bypass graft surgery (CABG) within 90 days prior to screening, or a percutaneous intervention (PCI) within 30 days prior to screening.
  • patients with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit or 90 days after randomization visit.
• For the entry into the double-blind treatment period (randomization):
  • HbA1c < 6.0% or > 10.0% measured at screening visit fasting plasma glucose > 13.9 mmol/L (> 250 mg/dL) measured at screening visit.

Study Phase: Phase III (What are Phases?)

To receive information and updates for this trial:
Please contact us and mention the Trial ID below.

Trial ID (ClinicalTrials.gov): NCT01147250

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