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

Recruiting

• Conditions: Coronary Artery Disease; Diabete Mellitus
• Interventions: Drug: SGLT2 inhibitor

• Registration Number: NCT05333159
• Lead Sponsor: Beijing Anzhen Hospital

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.

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 Timeline

• Study Start: 2021-09-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Last Update Submitted: 2022-04-12
• Study First Posted: 2022-04-18
• Last Update Posted: 2022-04-18
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1424

Inclusion Criteria

1. Age ≥18 years
2. Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.
3. Patients were provided informed consent before the procedure.

Exclusion Criteria

1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
2. History of one or more severe hypoglycemic episode within 6 months before screening
3. Ongoing, inadequately controlled thyroid disorder.
4. History of hepatitis B surface antigen or hepatitis C antibody positive
5. Any history of or planned bariatric surgery.
6. Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	SGLT2 inhibitor	Subjects will be treated with SGLT-2 inhibitors (dapagliflozin, canagliflozin, empagliflozin) with or without conventional hypoglycemic drugs .

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 glycated hemoglobin (HbA1c)	12 months	Changes of HbA1c at baseline prior to drug administration and at 12 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 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.

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China