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

NCT05333159 | Unknown FDA Drug

• 1 other identifier: KS2022016
• Study Type: observational
• Target: 1,424
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Diabete Mellitus

Keywords

coronary artery disease; diabetes mellitus; percutaneous coronary intervention; SGLT-2 inhibitor; insulin resistance; platelet reactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes of insulin resistance index

  3 months

• Changes of platelet reactivity

  3 months

• Changes of fasting plasma glucose (FPG) level

  12 months

• Changes of glycated hemoglobin (HbA1c)

  12 months

• Changes of plasma lipid parameters

  12 months

Study Arms (2)

Experimental

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

Drug: SGLT2 inhibitor

Control

Subjects will be only treated with conventional hypoglycemic drugs.

Interventions

SGLT2 inhibitor DRUG

dapagliflozin 10mg once daily dose canagliflozin100mg once daily dose empagliflozin 0mg once daily dose

Also known as: dapagliflozin, canagliflozin, empagliflozin

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus; Insulin Resistance

Interventions

Sodium-Glucose Transporter 2 Inhibitors; dapagliflozin; Canagliflozin; empagliflozin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• xiaofan Wu, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaofan Wu, MD

CONTACT

6445-6587; drwuxf@163.com

Yue Wang, MD

CONTACT

18910714716; 1091156087@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 18, 2022
• Study Start: September 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)