Clinical trial

Real World Observation of SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients With Acute Myocardial Infarction, a Prospective, Multi-center Registry Study

Name

KC19OEDI0591

Description

Prospective trials performed on type 2 diabetes patients without established cardiovascular disease has shown that SGLT2 inhibitors reduce cardiovascular risk. No studies have yet examined the occurrence of cardiovascular disease in patients with acute myocardial infarction. The investigators designed the current study to evaluate the most ideal oral hypoglycemic agent in type 2 diabetes patients undergoing percutaneous coronary intervention for acute myocardial infarction. The investigators hypothesize that the use of SGLT-2 inhibitors will reduce cardiovascular events and modify left ventricular remodeling after myocardial infarctions.

Trial arms

Trial start

2020-08-01

Estimated PCD

2025-12-31

Trial end

2026-12-31

Status

Recruiting

Treatment

SGLT2 inhibitor

Patients started on SGLT2 inhibitors after PCI for AMI

Arms:

SGLT-2 inhibitor

Other names:

dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin

Size

1000

Primary endpoint

Major adverse cardiac and cerebrovascular events

2 years

Eligibility criteria

Inclusion Criteria: * Acute myocardial infarction who were treated with percutaneous coronary intervention * Type 2 diabetes mellitus * Started SGLT2 inhibitors \<1 month before/after PCI Exclusion Criteria: * Type 1 diabetes mellitus * Insulin / GLP-1 analogue users * Previous users of SGLT2 inhibitors * Pregnancy

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}

Updated at

2023-03-15

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication