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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Diabete Mellitus
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1424

Contacts and Locations

• Study Contact: Name: xiaofan Wu, MD; Phone Number: 6445-6587; Email: drwuxf@163.com
• Study Contact Backup: Name: Yue Wang, MD; Phone Number: 18910714716; Email: 1091156087@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Anzhen Hospital
      • Contact: xiaofan Wu, MD; Phone Number: 6445-6587; Email: drwuxf@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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; empagliflozin; canagliflozin
Control; Subjects will be only treated with conventional hypoglycemic drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes of platelet reactivity	Changes of platelet reactivity at baseline prior to drug administration and at 3 months after the index PCI.	3 months
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
Changes of glycated hemoglobin (HbA1c)	Changes of HbA1c at baseline prior to drug administration and at 12 months after the index PCI.	12 months
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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: xiaofan Wu, MD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): December 30, 2024
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (ACTUAL): April 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery disease; insulin resistance; platelet reactivity; diabetes mellitus; SGLT-2 inhibitor
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Dapagliflozin; Empagliflozin; Sodium-Glucose Transporter 2 Inhibitors; Canagliflozin
• Other Study ID Numbers: KS2022016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes