Prospective, Randomized, Single Center, Open Label Study Designed to Evaluate the Effect on Platelet Reactivity in Response to High Doses of Atorvastatin or Rosuvastatin Administered Before Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer
研究概览
简要总结
The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independent of this enzyme)in patients at least 5 days in therapy with aspirin and clopidogrel (with or without an undergoing treatment with statins) undergoing PCI for coronary disease with chronic stable angina and/or evidence of inducible myocardial ischemia.
详细描述
An initial assessment of platelet reactivity in response to the TRAP (thrombin receptor agonist), ADP and arachidonic acid (respectively, indicative of the response to clopidogrel and aspirin) will be performed with impedance aggregometry (Multiplate® analyzer system). Patients with a increased residual platelet reactivity to ADP test (AUC > 47) will receive a different antiplatelet therapy and will then be excluded from the study, the other will be randomized to 3 groups 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years
- •Patients with chronic stable angina
- •Patients with coronary artery disease or with de novo stent restenosis of native vessels.
- •Patients who are able to understand the significance of this study and to adhere to recruitment by signing the informed consent.
排除标准
- •Acute Coronary Syndromes with an enzymatic movement (STEMI, NSTEMI).
- •Allergy or intolerance to atorvastatin, rosuvastatin, aspirin, clopidogrel.
- •Altered basal level of transaminase or CPK.
- •Patient with history of hepatitis-acute/chronic.
- •Patients already receiving high-dose statins.
- •Contraindications to antiplatelet therapy.
- •Patients with acute inflammatory disease and/or underlying chronic (hepatitis, pneumonia, urinary tract, rectum ulcerative colitis etc.).
- •Patients with anemia (haemoglobin <8.5 mg/dl), leukocytosis (WBC> 12.000 mm3), leukopenia (WBC <3000 mm3), platelet count <100.000; hypersplenism.
- •Patients with malignant disease.
- •Patients enrolled in other studies not yet completed.
- •Patients with known allergy / intolerance to statins.
- •Pregnant women and women who are breastfeeding.
- •Patients with myopathy (muscle pain and unexplained repeated)
研究组 & 干预措施
Atorvastatin
Atorvastatin 80 mg
干预措施: Atorvastatin (Drug)
Rosuvastatin
Rosuvastatin 40 mg
干预措施: Rosuvastatin (Drug)
No statin loading dose
No statin loading dose
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under the Aggregation Curve (AUC) measured with the Multiplate 5.0 Analyzer
时间窗: Evaluation of platelet reactivity (in terms of AUC) two time points.
Evaluation of the effect of a loading dose (LD) of two different statins on platelet reactivity (atorvastatin and rosuvastatin) in terms of difference between AUC value before statin LD and after 12 hrs statin LD. The Area Under the Aggregation Curve (AUC) will be measured with the Multiplate 5.0 system.
次要结局
- Incidence of periprocedural myocardial infarction(CK and CK-MB evaluated before the procedure and two time points up to 12 hours)