The Effect of Serum LDL Lowering on Aspirin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Spearsman's correlation coefficients will be calculated to determine the relation between changes in lipid parameters and changes in LDL tendency to oxidation and platelet aggregation.
研究概览
简要总结
Aspirin resistance is the persistent platelet activation, demonstrated by platelet function tests (1).
The hypothesis is that:LDL lowering by statin in patients with aspirin resistance can improve the effect of aspirin due to the potential decreasing of cholesterol content in the platelet membranes.
Patients and methods:Forty hypercholesterolemic patients with aspirin resistance after 5 days of treatment with aspirin and high LDL and triglycerides<300 mg/dL, will be enrolled.
Ten healthy volunteers will be the control group.
详细描述
The patients will be treated by aspirin loading dose of 500mg and then 100 mg/day for other 4 days. For patients that will be entrolled in the regular working hours, platelet aggregation test and cholesterol content in platelet membranes will be done at baseline.
Blood tests for lipids, liver (ALT,AST,GGT,Alkaline phosphatase and bilirubin) and renal function tests (blood urea nitrogen and creatinine), complete blood count, general urine test and serum homocysteine will be done on the second day.
On the fifth day optical platelet aggregation test, cholesterol content in platelet membranes, platelet function in the PFA-100 system and soluble p-selectin in the plasma will be done If the patient has aspirin resistance (platelet aggregation 20% with epinephrine or 70% with ADP), LDL will be lowered in the plasma of 20 patients by hypolipidemic drugs (statin alone or combined with ezetimibe). Other 20 patients will continue to be treated by aspirin alone.
One month later, blood tests for lipids, liver (ALT,AST,GGT,Alkaline phosphatase and bilirubin) and renal function tests (blood urea nitrogen and creatinine), complete blood count, general urine test and serum homocysteine will be done for the second time and platelet activity will be tested again for all patients.
Platelet separation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hypercholesterolemic low-moderate risk patients without hypolipidemic drugs for at least one month.
- •Age ≥18 years on stable AHA step 1 diet.
- •For primary prevention, LDL > 130 mg/dL and for secondary prevention LDL>70 and <100mg/dL. .
- •CPK, ALT and AST < 1.5 x upper limit of normal at baseline.
排除标准
- •Women currently receiving cyclical hormones.
- •Treatment with hypolipidemic drugs during the last month.
- •Oral corticosteroids, NSAID, COX-1 inhibitors and other antiplatelet drugs.
- •Women with childbearing potential unless on safe contraception.
- •Psychiatric disease with defect in judgement.
- •Severe renal or hepatic diease.
- •Uncontrolled hypo- or hyperthyroidism.
- •Contraindication for ezetimibe or statin treatment.
结局指标
主要结局
Spearsman's correlation coefficients will be calculated to determine the relation between changes in lipid parameters and changes in LDL tendency to oxidation and platelet aggregation.
次要结局
未报告次要终点