Evolocumab in STEMI

NCT06081803 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: EVO-STEMI_version 4.1
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the size of myocardial infarct between evolocumab and control groups in patients with ST segment elevation myocardial infarction who undergoing primary percutaneous coronary intervention(PCI). All study participants will undergo a cardiac MRI 4 weeks after primary reperfusion. The evolocumab group will receive 420 mg before PCI via subcutaneous injection.

Conditions

ST Elevation Myocardial Infarction

Keywords

PCSK9; percutaneous coronary intervention; Infarct size

Outcome Measures

Primary Outcomes (1)

• Myocardial infarct size

  assessed by cardiac MRI

  1 month after primary reperfusion

Secondary Outcomes (1)

• The incidence of MVO

  1 month after primary reperfusion

Other Outcomes (9)

• ST segment resolution

  1 hour after primary reperfusion

• Area under the curve of enzymatic infarct size

  within 48 hours after primary reperfusion

• Myocardial blush grade

  Immediate after primary reperfusion

Study Arms (2)

Evolocumab group

EXPERIMENTAL

Evolocumab 420mg subcutaneous injection before primary PCI

Drug: Repatha®

Control group

NO INTERVENTION

without Evolocumab 420mg before primary PCI

Interventions

Repatha® DRUG

Repatha® 140mg x 3 pens subcutaneous injection

Evolocumab group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Typical ischemic chest pain persists for more than 30 minutes
• An elevation of an ST segment greater than 1 mm in two consecutive leads or new-onset left bundle branch block
• Presenting more than 12 hours after the onset of symptoms

You may not qualify if:

• Previous history of myocardial infarction
• Previous history of coronary bypass surgery
• Cardiogenic shock that lasts more than 10 minutes or cardiac arrest
• Occlusion of the left main coronary artery
• Pregnant or have a plan of pregnancy
• Serum creatinine level is \>2.5mg/dL or dialysis is required

Sponsors & Collaborators

• Sejong General Hospital: lead
• Samsung Medical Center: collaborator
• National Health Insurance Service Ilsan Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Daegu Catholic University Medical Center: collaborator
• Catholic University of Korea Eunpyeong St. Mary's Hospital: collaborator

Study Sites (1)

Sejong General Hospital

Bucheon-si, 14574, South Korea

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Evolocumab group vs control group

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 13, 2023
• Study Start: December 5, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)