Status:
UNKNOWN
Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome
Lead Sponsor:
Tianjin Chest Hospital
Conditions:
Acute Coronary Syndrome
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is an open-label, multicenter, and randomized study(five hospitals).The purpose of this study is to assess the differences in the effects of the evolocumab added to moderate-intensity statin...
Eligibility Criteria
Inclusion
- Recent hospitalization for acute coronary syndrome: Complies with the diagnostic criteria for acute coronary syndrome (non-ST-segment elevation myocardial infarction, acute ST-segment elevation myocardial infarction, and unstable angina within 72 hours of onset)
- LDL-C level (meet one of the following conditions):
- Prior to the study, patients who received intensive statins for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥70 mg/dL (≥1.8 mmol/L) or non-HDL-C ≥100 mg /dL (≥2.6mmol/L) are included in the study;
- Prior to the study, patients who received moderate-intensity statin therapy for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥90 mg/dL (≥2.3 mmol/L) or non-HDL-C≥ 120mg/dL (≥3.1mmol/L) are included in the study;
- Prior to the study, patients who do not receive statin therapy or who do not continue to receive statin with LDL-C ≥ 125 mg/dL (≥ 3.2 mmol/L) or non-HDL-C ≥ 155 mg/dL (≥ 4.0 mmol/L).
- Being able to understand research requirements and sign informed consent
Exclusion
- Unstable clinical status (hemodynamics or ECG instability)
- Uncontrolled arrhythmia, defined as recurrent or symptomatic ventricular tachycardia and atrial fibrillation with rapid ventricular reaction that the drug cannot control within three months prior to screening
- Severe renal insufficiency, defined as estimated glomerular filtration rate\<30ml/min/1.73m2
- Active liver disease or liver dysfunction, whether it is on the patient's medical record or defined as an increase in alanine aminotransferase or aspartate aminotransferase more than 3 times above the upper limit of normal
- Records on statin or rosuvastatin (any dose) intolerance or other statin intolerance
- Known allergies to contrast agents, heparin, aspirin, ticagrelor or clopidogrel
- Known allergies to the supplements required for the use of the drug
- Patients who have been treated with evolocumab or other PCSK9 inhibitors
- Received cholesterol ester transfer protein inhibitors treatment 12 months prior to screening
- Received systemic steroid or cyclosporine treatment in the past 3 months
- Known infections, hemorrhages, metabolic or endocrine disorders as determined by the researchers
- Patients who have been included in other studies
- Patients with active malignant tumor in need of treatment
- Women with fertility (age \<50 years, menstruation in the past 12 months), did not receive tubal ligation, oophorectomy or hysterectomy
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04100434
Start Date
January 1 2021
End Date
June 1 2023
Last Update
November 24 2020
Active Locations (1)
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1
Tianjin Chest Hospital,
Tianjin, China, 300222