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

NCT ID: NCT05333159

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1424 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-12-30

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.

Conditions

Coronary Artery Disease; Diabete Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental

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

SGLT2 inhibitor

Intervention Type: DRUG

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

Control

Subjects will be only treated with conventional hypoglycemic drugs.

No interventions assigned to this group

Interventions

SGLT2 inhibitor

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

Intervention Type: DRUG

Other Intervention Names

dapagliflozin; canagliflozin; empagliflozin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaofan Wu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xiaofan Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiaofan Wu, MD

Role: CONTACT

drwuxf@163.com

6445-6587

Yue Wang, MD

Role: CONTACT

1091156087@qq.com

18910714716

Facility Contacts

xiaofan Wu, MD

Role: primary

drwuxf@163.com

6445-6587

Other Identifiers

KS2022016

Identifier Type: -

Identifier Source: org_study_id