Peri-treatment of SGLT-2 Inhibitor on Myocardial Infarct Size and Remodeling Index in Patients With Acute Myocardial Infarction and High Risk of Heart Failure Undergoing Percutaneous Coronary Intervention

NCT04899479 | Recruiting Phase 4 DMC

• 1 other identifier: PRESTIGE-AMI
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with acute myocardial infarction (AMI) and high risk of heart failure, and its mechanism. For this reason, we compared cardiac magnetic resonance imaging (CMR) parameters and clinical outcomes between the SGLT-2 inhibitor group and the control group to confirm the efficacy and safety of SGLT-2 inhibitors.

Conditions

Acute Myocardial Infarction; Heart Failure

Keywords

Percutaneous Coronary Intervention; Infarct size; Cardiac Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• Myocardial infract size (IS)

  IS measured using CMR

  at 6-month follow-up

• ∆Left ventricular end-systolic volume

  Difference of left ventricular end-systolic volume measured by CMR

  Between index hospitalization and 6-month follow-up

Secondary Outcomes (20)

• Acute kidney injury

  Within 3 days after index PCI

• Myocardial IS

  Within 3 days after index PCI

• Microvascular obstruction (MVO)

  Within 3 days after index PCI

• IS

  Within 3 days after index PCI

• ∆left ventricular end-diastolic volume

  Between index hospitalization and 6-month follow-up

Study Arms (2)

SGLT-2 inhibitor

EXPERIMENTAL

The SGLT-2 inhibitor group will receive SGLT-2 inhibitor once daily until the end of the study period.

Drug: SGLT2 inhibitor

Control

PLACEBO COMPARATOR

The control group will not receive any additional drugs.

Other: Control

Interventions

SGLT2 inhibitor DRUG

In patients with AMI and high risk of heart failure, 1:1 randomization will be performed to either SGLT2 inhibitor or control group.

SGLT-2 inhibitor

Control OTHER

In patients with AMI and high risk of heart failure, 1:1 randomization will be performed to either SGLT2 inhibitor or control group.

Control

Eligibility Criteria

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

You may qualify if:

• \) Subject must be at least 18 years of age 2) Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving SGLT-2 inhibitor and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure 3) Diagnosis of Type 1 myocardial infarction (MI) (ST-segment elevation MI \[STEMI\] or Non-ST-segment elevation MI \[NSTEMI\]) i) Detection of a rise and/or fall of cardiac troponin values with at least 1 value above the 99th percentile upper reference limit ii) Symptoms or electrocardiographic changes suggesting myocardial ischemia 4) High risk of heart failure (at least one of the two criteria below are met) i) Left ventricular ejection fraction \< 50% ii) Symptoms or signs of pulmonary congestion requiring treatment

You may not qualify if:

• \) Target lesion is not suitable for PCI by operator's decision 2) Patients requiring cardiopulmonary resuscitation due to cardiac arrest before randomization 3) Rescue PCI after thrombolysis or facilitated PCI 4) Previous MI 5) Previous history of heart failure 6) Patients who have been taking SGLT-2 inhibitor 7) Patients with glomerular filtration rate \< 30ml/min/1.73m2 or on dialysis 8) Type 1 diabetes mellitus (DM) 9) Known hypersensitivity or contraindications to study medications (SGLT-2 inhibitor) 10) Pregnant or lactating women 11) Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

Young Bin Song, MD, PhD

CONTACT

82-2-3410-1246; youngbin.song@gmail.com

Ki Hong Choi, MD

CONTACT

82-2-3410-6653; cardiokh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study, therefore, no masking will be performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization will be performed 1:1 between SGLT-2 inhibitor and control. Stratification will be done by DM and clinical presentation (STEMI vs. NSTEMI).

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: July 5, 2021
• Primary Completion: August 31, 2025
• Study Completion: December 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)