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

Phase 4

Recruiting

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

• Registration Number: NCT05613426
• Lead Sponsor: Henan Institute of Cardiovascular Epidemiology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-14
• Study Start: 2023-04-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive statin group	Rosuvastatin 20 mg	Rosuvastatin, 20 mg per day after randomization
Combined intensive statin and PCSK9 inhibitor group	Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]	Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization
PCSK9 inhibitor alone group	Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]	Evolocumab, 140 mg twice a month after randomization
Combined intensive statin and PCSK9 inhibitor group	Rosuvastatin 20 mg	Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization

Primary Outcome Measures

Name	Time	Method
Change in left ventricular ejection fraction (LVEF)	Baseline and 12 weeks	Echocardiography Core Laboratory, blinded analysis

Secondary Outcome Measures

Name	Time	Method
Change in left ventricular end diastolic/systolic diameter	Baseline and 12 weeks	Echocardiography Core Laboratory, blinded analysis
Change in left ventricular end diastolic/systolic volume	Baseline and 12 weeks	Echocardiography Core Laboratory, blinded analysis
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

Trial Locations

Locations (6)

The People's Hospital of Changyuan; 🇨🇳 Xinxiang, Henan, China

Hopeshine Minsheng Hospital of Xinzheng; 🇨🇳 Xinzheng, Henan, China

The People's Hospital of Xuchang; 🇨🇳 Xuchang, Henan, China

Fuwai Central China Cardiovascular Hospital; 🇨🇳 Zhengzhou, Henan, China

The People's Hospital of Gongyi; 🇨🇳 Gongyi, Henan, China

Kaifeng Central Hospital; 🇨🇳 Kaifeng, Henan, China