Status:
COMPLETED
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
Lead Sponsor:
Sanofi
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
Primary Objective: \- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, ...
Detailed Description
The estimated maximum study duration for the first randomized participant was approximately 204 weeks (± 14 days), with a median follow-up over all participants of approximately 91 weeks, broken down ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men and women who experienced a spontaneous ACS event (i.e., ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation MI (NSTEMI) or unstable angina) with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or Creatinine Kinase (CK)-MB) and the clinical presentation consistent with an ACS which lead to admission to an acute care facility, within 180 days following the ACS event and prior to screening.
- Participants with a history of type 2 diabetes (for participants newly diagnosed, diagnosis was 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 criteria:
- Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.
- Glycosylated hemoglobin (HbA1c) \<5.5 % or \>11% measured at screening visit.
- Required to use incretin-based agents (e.g., Glucagon-like peptide -1 (GLP-1) agonists or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the double-blind treatment period.
- Participants who had undergone coronary artery bypass graft (CABG) surgery following the qualifying ACS event.
- Participants who had undergone percutaneous coronary intervention (PCI) within 15 days prior to screening.
- Participants 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 (e.g., 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.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
6068 Patients enrolled
Trial Details
Trial ID
NCT01147250
Start Date
June 1 2010
End Date
February 1 2015
Last Update
December 20 2016
Active Locations (829)
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1
Investigational Site Number 840415
Birmingham, Alabama, United States, 35203
2
Investigational Site Number 840307
Foley, Alabama, United States, 36535
3
Investigational Site Number 840692
Mobile, Alabama, United States, 36604
4
Investigational Site Number 840037
Mobile, Alabama, United States, 36608