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Evolocumab in STEMI

Primary Purpose

ST Elevation Myocardial Infarction

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Repatha®
Sponsored by
Sejong General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring PCSK9, percutaneous coronary intervention, Infarct size

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Sejong General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Evolocumab group

Control group

Arm Description

Evolocumab 420mg subcutaneous injection before primary PCI

without Evolocumab 420mg before primary PCI

Outcomes

Primary Outcome Measures

Myocardial infarct size
assessed by cardiac MRI

Secondary Outcome Measures

The incidence of MVO
assessed by cardiac MRI

Full Information

First Posted
September 30, 2023
Last Updated
October 10, 2023
Sponsor
Sejong General Hospital
Collaborators
Samsung Medical Center, National Health Insurance Service Ilsan Hospital, Chonnam National University Hospital, Daegu Catholic University Medical Center, Inje University Ilsan Paik Hospital, Catholic University of Korea Eunpyeong St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06081803
Brief Title
Evolocumab in STEMI
Official Title
The Effect of Evolocumab on Infarct Size in Patients With ST-segment Elevation Myocardial Infarction; Prospective, Randomized, Open Label, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sejong General Hospital
Collaborators
Samsung Medical Center, National Health Insurance Service Ilsan Hospital, Chonnam National University Hospital, Daegu Catholic University Medical Center, Inje University Ilsan Paik Hospital, Catholic University of Korea Eunpyeong St. Mary's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The gold standard for the treatment of ST-segment elevation myocardial infarction (STEMI) is to rapidly restore myocardial blood flow through primary percutaneous coronary intervention (primary PCI) as soon as possible. While primary PCI achieves successful reperfusion of the infarct-related epicardial coronary artery in over 90% of these patients, only approximately 35% achieve ideal reperfusion to the myocardium level. This condition is termed myocardial no-reflow or microvascular obstruction (MVO). The primary pathophysiology of MVO includes severe inflammatory reactions within the ischemic vessel, distal embolization of thrombi, microthrombi formation in the microvasculature, and microvascular spasm, tissue peri-infarct edema, and intramyocardial hemorrhage. Previous studies has reported that the use of atorvastatin 80mg before PCI can reduce myocardial injury occurring during PCI in patients with acute coronary syndrome (ACS), and can improve microvascular blood flow in STEMI patients undergoing primary PCI. Furthermore, it has been reported to improve microvascular functional impairment evaluated by microvascular resistance index in non-ST-segment elevation acute coronary syndrome patients and exhibit anti-inflammatory effects. However, Two randomized trials atorvastatin 80mg did not reduce infarct size, which was primary endpoint in STEMI patients. Recently, strong LDL cholesterol-lowering agent, PCSK9 inhibitors, have been developed and used in clinical practice, and they seem to have pleiotropic effects similar to high-intensity statins, including anti-inflammatory and antithrombotic effects. In-vitro and vivo models have shown that the introduction of human PCSK9 increases platelet aggregation in normal adult plasma and that mice without PCSK9 exhibit decreased arterial thrombosis and thrombus stability when induced . Patients with higher levels of serum PCSK9 had higher platelet reactivity after antiplatelet therapy and an increased incidence of ischemic events following coronary intervention in ACS setting. This suggests that circulating PCSK9 contributes to arterial thrombus formation, and PCSK9 inhibition may improve this. Additionally, evolocumab is known to reduce Lp(a), which is well-known for its pro-atherosclerotic and pro-inflammatory effects, by approximately 30%. Also, Pharmaceutically, evolocumab exhibits maximum inhibitory effect against PCSK9 within just 4 hours of injection, potentially beneficial for patients with acute myocardial infarction who need a rapid effect before the infarction fully develops. In this clinical trial, we hypothesize that administering evolocumab before primary PCI in patients with acute STEMI may reduce MVO through its antiplatelet and anti-inflammatory effects and subsequently decrease the size of the myocardial infarction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
PCSK9, percutaneous coronary intervention, Infarct size

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Evolocumab group vs control group
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evolocumab group
Arm Type
Experimental
Arm Description
Evolocumab 420mg subcutaneous injection before primary PCI
Arm Title
Control group
Arm Type
No Intervention
Arm Description
without Evolocumab 420mg before primary PCI
Intervention Type
Drug
Intervention Name(s)
Repatha®
Intervention Description
Repatha® 140mg x 3 pens subcutaneous injection
Primary Outcome Measure Information:
Title
Myocardial infarct size
Description
assessed by cardiac MRI
Time Frame
1 month after primary reperfusion
Secondary Outcome Measure Information:
Title
The incidence of MVO
Description
assessed by cardiac MRI
Time Frame
1 month after primary reperfusion
Other Pre-specified Outcome Measures:
Title
ST segment resolution
Description
assessed by 12-leads ECG
Time Frame
1 hour after primary reperfusion
Title
Area under the curve of enzymatic infarct size
Time Frame
within 48 hours after primary reperfusion
Title
Myocardial blush grade
Description
assessed by coronary angiography
Time Frame
Immediate after primary reperfusion
Title
Corrected TIMI frame count
Description
assessed by coronary angiography
Time Frame
Immediate after primary reperfusion
Title
TIMI myocardial perfusion grade
Description
assessed by coronary angiography
Time Frame
Immediate after primary reperfusion
Title
The change of LDL-Cholesterol from baseline
Time Frame
1 month after primary reperfusion
Title
The change of Lipoprotein (a) from baseline
Time Frame
1 month after primary reperfusion
Title
Platelet reactivity on treatment
Description
Assessed by Verifynow
Time Frame
1 month after primary reperfusion
Title
Hs-CRP level
Time Frame
1 month after primary reperfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Jong Lee, MD, PhD
Phone
82-10-6217-9315
Email
untouchables00@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Su Jung Lee, RN
Phone
82-32-340-1812
Email
bjwwoki0827@daum.net
Facility Information:
Facility Name
Sejong General Hospital
City
Bucheon
ZIP/Postal Code
14574
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Jong Lee, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Evolocumab in STEMI

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