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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333159
• Other study ID #: KS2022016
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2022
• Source: Beijing Anzhen Hospital
• Contact: xiaofan Wu, MD
• Phone: 6445-6587
• Email: drwuxf[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1424
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabete Mellitus
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Drug:
• SGLT2 inhibitor
dapagliflozin 10mg once daily dose canagliflozin100mg once daily dose empagliflozin 0mg once daily dose

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Changes of platelet reactivity	Changes of platelet reactivity at baseline prior to drug administration and at 3 months after the index PCI.	3 months
Secondary	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
Secondary	Changes of glycated hemoglobin (HbA1c)	Changes of HbA1c at baseline prior to drug administration and at 12 months after the index PCI.	12 months
Secondary	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