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RECRUITING
NCT05613426
PHASE4

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

Sponsor: Henan Institute of Cardiovascular Epidemiology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2023-04-03

Completion Date

2026-12-30

Last Updated

2024-12-27

Healthy Volunteers

No

Interventions

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

Locations (6)

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, China