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

Capital Medical University

Status: Enrolling

Conditions: Coronary Artery Disease; Diabete Mellitus

Treatments: Drug: SGLT2 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT05333159

KS2022016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,424 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,424 participants in 2 patient groups

Experimental

Description:

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

Treatment:

Drug: SGLT2 inhibitor

Control

Description:

Subjects will be only treated with conventional hypoglycemic drugs.