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

Henan Institute of Cardiovascular Epidemiology

Status and phase: Enrolling; Phase 4

Conditions: ST Elevation Myocardial Infarction (STEMI)

Treatments: Drug: Rosuvastatin 20 mg; Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]

Study type: Interventional

Funder types: Other

Identifiers

NCT05613426

HenanICE202204

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 3 patient groups

Intensive statin group

Active Comparator group

Description:

Rosuvastatin, 20 mg per day after randomization

Treatment:

Drug: Rosuvastatin 20 mg

Combined intensive statin and PCSK9 inhibitor group

Experimental group

Description:

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

Treatment:

Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]

Drug: Rosuvastatin 20 mg

PCSK9 inhibitor alone group

Experimental group

Description:

Evolocumab, 140 mg twice a month after randomization

Treatment:

Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]