NCT05770687

Brief Summary

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Aug 2020Dec 2026

Study Start

First participant enrolled

August 1, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

5.4 years

First QC Date

March 5, 2023

Last Update Submit

January 1, 2025

Conditions

Myocardial InfarctionDiabetes Mellitus, Type 2

Keywords

Percutaneous Coronary InterventionSGLT-2 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac and cerebrovascular events

    A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization

    2 years

Secondary Outcomes (14)

  • Cardiac death

    2 years

  • Nonfatal myocardial infarction

    2 years

  • Nonfatal stroke

    2 years

  • Hospitalization for heart failure

    2 years

  • Target lesion revascularization

    2 years

  • +9 more secondary outcomes

Study Arms (1)

SGLT-2 inhibitor

Patients with naive use of SGLT-2 inhibitors after PCI

Drug: SGLT2 inhibitor

Interventions

SGLT2 inhibitorDRUG

Patients started on SGLT2 inhibitors after PCI for AMI

Also known as: dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin
SGLT-2 inhibitor

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetes mellitus patients undergoing percutaneous coronary intervention for acute myocardial infarction

You may qualify if:

  • Acute myocardial infarction who were treated with percutaneous coronary intervention
  • Type 2 diabetes mellitus
  • Started SGLT2 inhibitors \<1 month before/after PCI

You may not qualify if:

  • Type 1 diabetes mellitus
  • Insulin / GLP-1 analogue users
  • Previous users of SGLT2 inhibitors
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionDiabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitorsdapagliflozinempagliflozinertugliflozinipragliflozin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • Kiyuk Chang, MD, PhD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiyuk Chang, MD, PhD

CONTACT

82-2-2258-1139kiyuk@catholic.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 15, 2023

Study Start

August 1, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

January 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)