myocardial infarction
Conditions
Interventions
control group:without PCSK9 inhibitor evolocumab injected
evolocumab group:PCSK9 inhibitor evolocumab 140 mg subcutaneously injected once as soon as possible before revascularization + 14 days after the first dose
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the followings: 1. Male and female patients aged 18-75 years old. 2. Patients must be statins-na?ve in the previous 30 days. 3. Meeting the diagnostic criteria for acute MI, including non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI), and receiving coronary intervention therapy within 24 hours of onset. The diagnostic criteria for NSTEMI and STEMI should include cardiac marker levels exceeding the 99th percentile of upper limit of normal reference level (URL) at least once and at least one of the followings: ischemic symptoms; new onset ST-T change or left bundle branch block (LBBB); pathological Q waves; new imaging evidence of local cardiac wall motion abnormality or new loss of viable myocardium; coronary artery thrombosis found by angiography. The ST segment elevation is defined as new ST segment elevation at the J point of two adjacent leads. Except for the V2-V3 leads, all lead elevations should be >= 0.1 mV, and the V2-V3 leads should be elevated >= 0.25 mV for men = 0.2 mV for men >= 40 years old, and >= 0.15mV for women. The ST-segment depression and T-wave change are defined as new onset horizontal or down-slope ST-segment depression >= 0.05 mV, or inverted T wave >= 0.1mV when R wave is dominant on two adjacent leads. 4. Signing the informed consent form prior to any inspection or operation as specified in the program.
Exclusion criteria
Exclusion criteria: 1. Currently taking medication that may interact with the statin or PCSK9 inhibitor - evolocumab, and may increase the risk of rhabdomyolysis; 2. Currently taking cholesterol absorption inhibitors (Ezetimibe), fibrates, niacin and other lipid-lowering drugs; 3. Severe liver and renal dysfunction, e.g. estimated glomerulus filtration rate (eGFR) = 3 times URL; 4. Obstructive jaundice, active liver disease, chronic hepatitis; 5. Myopathy, creatine kinase (CK) >= 5 times URL or increased CK with unknown cause or intolerance for lipid-lowering therapy; 6. Patients with a positive pregnancy test, women of childbearing age and lactation who have not used contraception; 7. Malignant tumor, rheumatoid connective tissue disease; 8. Patients who are allergic to statins or the PCSK9 inhibitor - evolocumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major adverse cardiovascular events; | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary end point; | — |
Countries
China
Contacts
Public ContactWenbin Zhang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed