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

Sponsor

Beijing Anzhen Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05333159

Collaborator

(none)

1,424

Enrollment

Location

Anticipated Duration (Months)

35.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Diabete Mellitus	Drug: SGLT2 inhibitor

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

1424 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental

Subjects will be treated with SGLT-2 inhibitors (dapagliflozin, canagliflozin, empagliflozin) with or without conventional hypoglycemic drugs .

Drug: SGLT2 inhibitor

dapagliflozin 10mg once daily dose canagliflozin100mg once daily dose empagliflozin 0mg once daily dose

Other Names:

dapagliflozin

canagliflozin

empagliflozin

Control

Subjects will be only treated with conventional hypoglycemic drugs.

Outcome Measures

Primary Outcome Measures

Major adverse cardiovascular and cerebrovascular events (MACCEs) [12 months]
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.

Secondary Outcome Measures

Changes of insulin resistance index [3 months]
Changes of insulin resistance index at baseline prior to drug administration and at 3 months after the index PCI.
Changes of platelet reactivity [3 months]
Changes of platelet reactivity at baseline prior to drug administration and at 3 months after the index PCI.
Changes of fasting plasma glucose (FPG) level [12 months]
Changes of FPG level at baseline prior to drug administration and at 3 months after the index PCI.
Changes of glycated hemoglobin (HbA1c) [12 months]
Changes of HbA1c at baseline prior to drug administration and at 12 months after the index PCI.
Changes of plasma lipid parameters [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.