Actively Recruiting
Effect of Early and Rapid Cholesterol Lowering with Evolocumab on Heart Muscle Recovery in Anterior STEMI Patients Undergoing Primary PCI A Randomized Clinical Trial Evaluating Evolocumab and Rosuvastatin Treatments
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
Researchers are investigating whether early treatment with the drug evolocumab, a PCSK9 inhibitor, can quickly lower LDL cholesterol levels before primary percutaneous coronary intervention (PCI) and help prevent harmful changes in the heart's left ventricle in patients with anterior ST elevation myocardial infarction (STEMI). This Phase 4 trial compares the effects of evolocumab alone, rosuvastatin alone, and a combination of both drugs on heart remodeling after STEMI. Participants are randomly assigned to one of three groups: (1) rosuvastatin 20 mg daily with standard care; (2) rosuvastatin 20 mg daily plus evolocumab 140 mg subcutaneously twice a month; or (3) evolocumab 140 mg subcutaneously twice a month alone. Treatment lasts at least three months, preferably six. All treatments begin very early before the primary PCI procedure. During the study, participants will have their heart function measured by left ventricular ejection fraction (LVEF) at the start and after 12 weeks. Researchers will monitor cholesterol levels and heart remodeling effects. The total participation period includes these assessments and treatment monitoring to evaluate the impact of rapid cholesterol lowering on heart recovery after STEMI.
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
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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
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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