The study is to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus undergoing percutaneous coronary intervention.
This is a single center, observational study designed to evaluate the efficacy of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention (PCI). 1424 subjects will be enrolled. All patients were divided into the SGLT-2 inhibitors group and other oral hypoglycemic agents group according to whether they were discharged with SGLT-2 inhibitors or not. The primary endpoint is adverse cardiovascular and cerebrovascular events (MACCE), composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and unplanned coronary revascularization at 12 months after the index PCI. The key secondary endpoints are changes in insulin resistance index and platelet reactivity at 3 months and change in glucose and lipid metabolism at 12 months after the index PCI.
Study Type
OBSERVATIONAL
Enrollment
1,424
dapagliflozin 10mg once daily dose canagliflozin100mg once daily dose empagliflozin 0mg once daily dose
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
RECRUITINGMajor adverse cardiovascular and cerebrovascular events (MACCEs)
MACCE, defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal myocardial stroke and unplanned coronary revascularization. Event rates are adjudicated by an endpoint committee based on the time to the first occurrence of MACCEs.
Time frame: 12 months
Changes of insulin resistance index
Changes of insulin resistance index at baseline prior to drug administration and at 3 months after the index PCI.
Time frame: 3 months
Changes of platelet reactivity
Changes of platelet reactivity at baseline prior to drug administration and at 3 months after the index PCI.
Time frame: 3 months
Changes of fasting plasma glucose (FPG) level
Changes of FPG level at baseline prior to drug administration and at 3 months after the index PCI.
Time frame: 12 months
Changes of glycated hemoglobin (HbA1c)
Changes of HbA1c at baseline prior to drug administration and at 12 months after the index PCI.
Time frame: 12 months
Changes of plasma lipid parameters
Changes of plasma lipid parameters including triglycerides, high-density lipoprotein cholesterol and low density lipoprotein cholesterol and total cholesterol at baseline prior to drug administration and at 12 months after the index PCI.
Time frame: 12 months
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