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Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI (EVALUATE-STEMI)

Primary Purpose

ST Elevation Myocardial Infarction (STEMI)

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Rosuvastatin 20 mg

Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction (STEMI) focused on measuring ST Elevation Myocardial Infarction, percutaneous coronary intervention, PCSK9 Inhibitors, left ventricular remodeling

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75 years Persistent chest pain or chest discomfort Onset within 12 hours ST-segment elevation ≥0.1 millivolt in two adjacent precordial leads, or a new-onset left bundle branch block with dynamic changes Primary PCI is planned Exclusion Criteria: Contraindications to Statins or PCSK9 inhibitors Prior intravenous thrombolytic therapy Prior use of Statins, PCSK9 inhibitors or Ezetimibe Cardiogenic shock Acute heart failure or pulmonary edema Prior chronic heart failure Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate <30ml/min/1.73m2, or on dialysis) Prolonged (> 20 minutes) cardiopulmonary resuscitation Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall) Malignant arrhythmias that are difficult to control with drugs Severe chronic obstructive pulmonary disease or respiratory failure Severe infection Neurological disorders Bleeding history of cerebrovascular, gastrointestinal, respiratory, urinary or other organs within the last month Active bleeding or bleeding diatheses Use of anticoagulants Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year Pregnant or lactating women

Sites / Locations

The People's Hospital of GongyiRecruiting
Kaifeng Central HospitalRecruiting
The People's Hospital of ChangyuanRecruiting
Hopeshine Minsheng Hospital of XinzhengRecruiting
The People's Hospital of XuchangRecruiting
Fuwai Central China Cardiovascular Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Intensive statin group

Combined intensive statin and PCSK9 inhibitor group

PCSK9 inhibitor alone group

Arm Description

Rosuvastatin, 20 mg per day after randomization

Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization

Evolocumab, 140 mg twice a month after randomization

Outcomes

Primary Outcome Measures

Change in left ventricular ejection fraction (LVEF)

Echocardiography Core Laboratory, blinded analysis

Secondary Outcome Measures

Change in left ventricular end diastolic/systolic diameter

Echocardiography Core Laboratory, blinded analysis

Change in left ventricular end diastolic/systolic volume

Echocardiography Core Laboratory, blinded analysis

A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure

Proportion of LDL-C < 1.4 mmol/L

Thrombolysis in Myocardial Infarction (TIMI) flow grade

Level of troponin

Number of patients with adverse events and serious adverse events

Full Information

NCT ID

NCT05613426

First Posted

October 18, 2022

Last Updated

June 25, 2023

Sponsor

Henan Institute of Cardiovascular Epidemiology

1. Study Identification

Unique Protocol Identification Number

NCT05613426

Brief Title

Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI

Acronym

EVALUATE-STEMI

Official Title

Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (EVALUATE-STEMI Trial): a Prospective, Multicenter, Open-label, Adjudicator-blinded, Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 3, 2023 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Henan Institute of Cardiovascular Epidemiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

For patients with anterior ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), whether early application of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors to rapidly reduce low-density lipoprotein cholesterol (LDL-C) before PCI could effectively inhibit left ventricular remodeling has been rarely reported. The aim of this study was to investigate the effect of early application of PCSK9 inhibitors Evolocumab to rapidly reduce LDL-C levels before primary PCI treatment on left ventricular remodeling in STEMI patients. Eligible patients were randomly randomized 1:1:1 to one of the following three groups immediately after enrollment: (1) Intensive statin group: rosuvastatin 20 mg per day, in addition to usual therapy; (2) Combined intensive statin and PCSK9 inhibitor group: rosuvastatin 20 mg per day and subcutaneous injection of evolocumab 140 mg twice a month, for at least 3 months, and preferably 6 months; (3) PCSK9 inhibitor alone group: subcutaneous injection of evolocumab 140 mg, twice a month for at least 3 months and preferably 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST Elevation Myocardial Infarction (STEMI)

Keywords

ST Elevation Myocardial Infarction, percutaneous coronary intervention, PCSK9 Inhibitors, left ventricular remodeling

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intensive statin group

Arm Type

Active Comparator

Arm Description

Rosuvastatin, 20 mg per day after randomization

Arm Title

Combined intensive statin and PCSK9 inhibitor group

Arm Type

Experimental

Arm Description

Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization

Arm Title

PCSK9 inhibitor alone group

Arm Type

Experimental

Arm Description

Evolocumab, 140 mg twice a month after randomization

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 20 mg

Intervention Description

Very early use of Rosuvastatin before primary PCI in anterior STEMI

Intervention Type

Drug

Intervention Name(s)

Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]

Intervention Description

Very early use of Evolocumab before primary PCI in anterior STEMI

Primary Outcome Measure Information:

Title

Change in left ventricular ejection fraction (LVEF)

Description

Echocardiography Core Laboratory, blinded analysis

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in left ventricular end diastolic/systolic diameter

Description

Echocardiography Core Laboratory, blinded analysis

Time Frame

Baseline and 12 weeks

Title

Change in left ventricular end diastolic/systolic volume

Description

Echocardiography Core Laboratory, blinded analysis

Time Frame

Baseline and 12 weeks

Title

A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure

Time Frame

12 weeks, 52 weeks

Title

Proportion of LDL-C < 1.4 mmol/L

Time Frame

One week, 12 weeks

Title

Thrombolysis in Myocardial Infarction (TIMI) flow grade

Time Frame

TIMI flow in culprit coronary artery at first coronary angiography, and immediately after primary PCI within 12 hours of onset

Title

Level of troponin

Time Frame

24 hours, 48 hours, and at hospital discharge, an average of 10 days after randomization

Title

Number of patients with adverse events and serious adverse events

Time Frame

At hospital discharge, an average of 10 days after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

You Zhang, Doctor

Phone

+86 37158681037

youzhangww@hotmail.com

Facility Information:

Facility Name

The People's Hospital of Gongyi

City

Gongyi

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lei Li

First Name & Middle Initial & Last Name & Degree

Lei Li

Facility Name

Kaifeng Central Hospital

City

Kaifeng

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jieyun Liu

First Name & Middle Initial & Last Name & Degree

Lei Qin

Facility Name

The People's Hospital of Changyuan

City

Xinxiang

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guangyan He

First Name & Middle Initial & Last Name & Degree

Ruiyang Chen

Facility Name

Hopeshine Minsheng Hospital of Xinzheng

City

Xinzheng

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanhong Li

First Name & Middle Initial & Last Name & Degree

Yanhong Li

Facility Name

The People's Hospital of Xuchang

City

Xuchang

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuya Zhou

First Name & Middle Initial & Last Name & Degree

Fei Xing, Master

Facility Name

Fuwai Central China Cardiovascular Hospital

City

Zhengzhou

State/Province

Henan

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junhui Zhang, Doctor

Phone

008637158681033

12. IPD Sharing Statement

Learn more about this trial

Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI

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