The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Efficacy of SGLT-2 Inhibitor After Stent Implantation in Patients With Coronary Heart Disease and Diabetes Mellitus：a Prospective Cohort Study

Conditions
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Coronary Artery Disease, Diabete Mellitus

Intervention / Treatment
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* Drug: SGLT2 inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention. Patients were provided informed consent before the procedure. Exclusion Criteria: History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy. History of one or more severe hypoglycemic episode within 6 months before screening Ongoing, inadequately controlled thyroid disorder. History of hepatitis B surface antigen or hepatitis C antibody positive Any history of or planned bariatric surgery. Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental<br>Subjects will be treated with SGLT-2 inhibitors (dapagliflozin, canagliflozin, empagliflozin) with or without conventional hypoglycemic drugs . | Drug: SGLT2 inhibitor<br>* dapagliflozin 10mg once daily dose canagliflozin100mg once daily dose empagliflozin 0mg once daily dose<br>* Other names: empagliflozin;|
| Control<br>Subjects will be only treated with conventional hypoglycemic drugs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of insulin resistance index | Changes of insulin resistance index at baseline prior to drug administration and at 3 months after the index PCI. | 3 months | 
| Changes of platelet reactivity | Changes of platelet reactivity at baseline prior to drug administration and at 3 months after the index PCI. | 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. | 12 months | 
| Changes of glycated hemoglobin (HbA1c) | Changes of HbA1c at baseline prior to drug administration and at 12 months after the index PCI. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, diabetes mellitus, percutaneous coronary intervention, SGLT-2 inhibitor, insulin resistance, platelet reactivity