Actively Recruiting
Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI
Led by Henan Institute of Cardiovascular Epidemiology · Updated on 2024-12-27
330
Participants Needed
6
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years
- Persistent chest pain or chest discomfort
- Symptoms started within 12 hours
- ST-segment elevation 30.1 millivolt in two adjacent precordial leads or new left bundle branch block with dynamic changes
- Planned primary percutaneous coronary intervention (PCI)
You will not qualify if you...
- 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 liver or kidney problems (alanine aminotransferase >5 times upper limit or eGFR <30 ml/min/1.73m2 or on dialysis)
- Prolonged cardiopulmonary resuscitation (>20 minutes)
- Mechanical complications such as ventricular septal perforation or ruptures
- Hard-to-control malignant arrhythmias
- Severe chronic obstructive pulmonary disease or respiratory failure
- Severe infection
- Neurological disorders
- Bleeding in various organs within last month
- Active bleeding or bleeding disorders
- Use of anticoagulants
- Malignant tumors or conditions with expected survival under 1 year
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
The People's Hospital of Gongyi
Gongyi, Henan, China
Actively Recruiting
2
Kaifeng Central Hospital
Kaifeng, Henan, China
Actively Recruiting
3
The People's Hospital of Changyuan
Xinxiang, Henan, China
Actively Recruiting
4
Hopeshine Minsheng Hospital of Xinzheng
Xinzheng, Henan, China
Actively Recruiting
5
The People's Hospital of Xuchang
Xuchang, Henan, China
Actively Recruiting
6
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
Research Team
Y
You Zhang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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