Clinical trial NCT05333159: The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.
Official title: Clinical Efficacy of SGLT-2 Inhibitor After Stent Implantation in Patients With Coronary Heart Disease and Diabetes Mellitus：a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Diabete Mellitus
Keywords: coronary artery disease
diabetes mellitus
percutaneous coronary intervention
SGLT-2 inhibitor
insulin resistance
platelet reactivity
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 1424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse cardiovascular and cerebrovascular events (MACCEs)
timeFrame: 12 months
Secondary outcomes:
measure: Changes of insulin resistance index
timeFrame: 3 months
measure: Changes of platelet reactivity
timeFrame: 3 months
measure: Changes of fasting plasma glucose (FPG) level
timeFrame: 12 months
measure: Changes of glycated hemoglobin (HbA1c)
timeFrame: 12 months
measure: Changes of plasma lipid parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: xiaofan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: