CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)
This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems.
• Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg/dL; or a 2-hour plasma glucose level of 140-199 mg/dL following a 75 g glucose load oral glucose tolerance test.
• Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation.
⁃ Coronary artery disease is fulfilled by at least one of (1), (2), or (3):
• History of myocardial infarction at least one month prior to randomization.
• History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.
• Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries.
⁃ Cerebrovascular disease is fulfilled by at least one of criteria (1) through (4):
• Documented prior ischemic stroke (at least one month prior to randomization),
• Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s),
• Asymptomatic carotid stenosis of at least 70% luminal diameter,
• History of carotid revascularization (surgical or catheter-based).
⁃ Peripheral arterial disease: Fulfilled by at least one of the following:
• History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia,
• Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85.
⁃ 3\. Renal function: Estimated glomerular filtration rate at least 45 mL/min/1.73 m2.
⁃ 4\. Informed consent has been fully executed, and participant agrees to study procedures.