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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The People's Hospital of Gongyi
RECRUITING
Gongyi
Kaifeng Central Hospital
RECRUITING
Kaifeng
The People's Hospital of Changyuan
RECRUITING
Xinxiang
Hopeshine Minsheng Hospital of Xinzheng
RECRUITING
Xinzheng
The People's Hospital of Xuchang
RECRUITING
Xuchang
Fuwai Central China Cardiovascular Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
You Zhang, Doctor
youzhangww@hotmail.com
+86 37158681037
Time Frame
Start Date: 2023-04-03
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 330
Treatments
Active_comparator: Intensive statin group
Rosuvastatin, 20 mg per day after randomization
Experimental: Combined intensive statin and PCSK9 inhibitor group
Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization
Experimental: PCSK9 inhibitor alone group
Evolocumab, 140 mg twice a month after randomization
Sponsors
Leads: Henan Institute of Cardiovascular Epidemiology

This content was sourced from clinicaltrials.gov

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