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

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

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.

Study Overview

• Status: Terminated
• Conditions: ST Elevation Myocardial Infarction (STEMI)
• Intervention / Treatment: Drug: Rosuvastatin 20 mg; Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Henan
    • Gongyi, Henan, China
      • The People's Hospital of Gongyi
    • Kaifeng, Henan, China
      • Kaifeng Central Hospital
    • Xinxiang, Henan, China
      • The People's Hospital of Changyuan
    • Xinzheng, Henan, China
      • Hopeshine Minsheng Hospital of Xinzheng
    • Xuchang, Henan, China
      • The People's Hospital of Xuchang
    • Zhengzhou, Henan, China
      • Fuwai Central China Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intensive statin group; Rosuvastatin, 20 mg per day after randomization	Drug: Rosuvastatin 20 mg; Very early use of Rosuvastatin before primary PCI in anterior STEMI
Experimental: Combined intensive statin and PCSK9 inhibitor group; Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization	Drug: Rosuvastatin 20 mg; Very early use of Rosuvastatin before primary PCI in anterior STEMI; Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]; Very early use of Evolocumab before primary PCI in anterior STEMI
Experimental: PCSK9 inhibitor alone group; Evolocumab, 140 mg twice a month after randomization	Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]; Very early use of Evolocumab before primary PCI in anterior STEMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in left ventricular ejection fraction (LVEF)	Echocardiography Core Laboratory, blinded analysis	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in left ventricular end diastolic/systolic diameter	Echocardiography Core Laboratory, blinded analysis	Baseline and 12 weeks
Change in left ventricular end diastolic/systolic volume	Echocardiography Core Laboratory, blinded analysis	Baseline and 12 weeks
A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure		12 weeks, 52 weeks
Proportion of LDL-C < 1.4 mmol/L		One week, 12 weeks
Thrombolysis in Myocardial Infarction (TIMI) flow grade		TIMI flow in culprit coronary artery at first coronary angiography, and immediately after primary PCI within 12 hours of onset
Level of troponin		24 hours, 48 hours, and at hospital discharge, an average of 10 days after randomization
Number of patients with adverse events and serious adverse events		At hospital discharge, an average of 10 days after randomization

Collaborators and Investigators

• Sponsor: Henan Institute of Cardiovascular Epidemiology

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): July 16, 2025
• Study Completion (Actual): May 16, 2026

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; PCSK9 Inhibitors; ST Elevation Myocardial Infarction; left ventricular remodeling
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Ventricular Remodeling; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Rosuvastatin Calcium; evolocumab
• Other Study ID Numbers: HenanICE202204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No