NCT04100434Unknown4 期
Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percent change in LDL-C
研究概览
简要总结
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 therapy and the moderate-intensity statin only therapy on the regulation of LDL-C levels in patients with acute phase acute coronary syndrome after four weeks of treatment. The primary outcome is the percentage change in LDL-C in weeks 4 and week 12 after treatment. The secondary outcome is the occurrence of MACE after 12 weeks and 1 year of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
the evolocumab plus statin therapy
Experimental
Patients with ACS are treated with atorvastatin (20mg) daily and evolocumab (140 mg) every two weeks throughout the study period
干预措施: Evolocumab (Drug)
结局指标
主要结局
Percent change in LDL-C
时间窗: 4 weeks
次要结局
- Major cardiovascular adverse events(4 weeks and 1 year)
研究者
Yin Liu,MD
Director of coronary care unit
Tianjin Chest Hospital
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3HyperlipidemiaNCT01984424Amgen511
已完成
2 期
Open Label Study of Long Term Evaluation Against LDL-C TrialHypercholesterolemiaNCT01439880Amgen1,324
尚未招募
Unknown
A comparative study of EVOlocumab and high-intensity statin for EARLY and intensive LDL-Cholesterol reduction in patients with acute coronary syndrome; Multi-center, prospective, randomized, double blinded, sham-procedure and placebo controlled trialKCT0009668BUCHEON SEJONG HOSPITA108
已完成
3 期
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label ExtensionDyslipidemiaNCT02867813Amgen5,035
已完成
3 期
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2HyperlipidemiaNCT01763905Amgen307