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

ST Elevation Myocardial Infarction (STEMI) Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613426
• Other study ID #: HenanICE202204
• Status: Recruiting
• Phase: Phase 4
• Start date: April 3, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: You Zhang, Doctor
• Phone: +86 37158681037
• Email: youzhangww[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST Elevation Myocardial Infarction (STEMI)
• Ventricular Remodeling

Intervention

Drug:
• Rosuvastatin 20 mg
Very early use of Rosuvastatin before primary PCI in anterior STEMI
• Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]
Very early use of Evolocumab before primary PCI in anterior STEMI

Locations

Country	Name	City	State
China	The People's Hospital of Gongyi	Gongyi	Henan
China	Kaifeng Central Hospital	Kaifeng	Henan
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular ejection fraction (LVEF)	Echocardiography Core Laboratory, blinded analysis	Baseline and 12 weeks
Secondary	Change in left ventricular end diastolic/systolic diameter	Echocardiography Core Laboratory, blinded analysis	Baseline and 12 weeks
Secondary	Change in left ventricular end diastolic/systolic volume	Echocardiography Core Laboratory, blinded analysis	Baseline and 12 weeks
Secondary	A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure		12 weeks, 52 weeks
Secondary	Proportion of LDL-C < 1.4 mmol/L		One week, 12 weeks
Secondary	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
Secondary	Level of troponin		24 hours, 48 hours, and at hospital discharge, an average of 10 days after randomization
Secondary	Number of patients with adverse events and serious adverse events		At hospital discharge, an average of 10 days after randomization