Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer
研究概览
简要总结
To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute coronary syndrome endothelial function -as a surrogate parameter of NO bioavailability- and different markers of inflammation, oxidative stress and platelet activation will be assessed in patients with unstable angina.
详细描述
Trial Objectives To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute coronary syndrome, endothelial function -as a surrogate parameter of NO bioavailability- and different markers of inflammation, oxidative stress and platelet activation will be assessed in patients with unstable angina.
Trial Design Single center, double blind, double-dummy, randomized, parallel trial.
Endpoints
Primary Endpoint Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer.
Secondary Endpoints
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Acute coronary syndrome, unstable angina
- •planned percutaneous coronary intervention
- •Written informed consent
排除标准
- •- Age < 18 years or ≥75 years
- •Body weight < 60 kg
- •STEMI, NSTEMI
- •Cardiogenic shock at the time of randomization
- •Refractory ventricular arrhythmias
- •Congestive heart failure (NYHA IV)
- •Increased risk of bleeding
- •Active internal bleeding or history of hemorrhagic diathesis
- •History of TIA, ischemic or hemorrhagic stroke
- •Intracranial neoplasm, aneurysm and arteriovenous malformation
- •INR > 1.5 at screening
- •Platelets < 100,000/ml
- •Anemia (Hb < 10 g/dl) at screening
- •One or more doses of a thienopyridine 5 d or less before PCI
- •Oral anticoagulation which cannot be safely discontinued for the duration of the study
- •One or more doses of a thienopyridine 5 d or less before PCI
- •Treatment within the last 30 d with an investigational drug or are presently enrolled in another drug or device study
- •Women who are known to be pregnant, have given birth within the past 90 d, or are breast-feeding
- •Concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period
- •Known severe hepatic dysfunction
- •Any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence
- •Intolerance of or allergy to aspirin, ticlopidine, or clopidogrel
研究组 & 干预措施
Prasugrel
3 months treatment with 10 mg prasugrel
干预措施: Prasugrel (Drug)
Clopidogrel
3 months treatment with clopidogrel 75 mg
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Assessment of endothelial function (FMD) via high-resolution ultrasound (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer
时间窗: baseline and after 3 months
The primary endpoint is the change of endothelial function given in % from baseline to 3 months after therapy with prasugrel versus clopidogrel.
次要结局
未报告次要终点
研究者
Tanja Rudolph
Consultant
University of Cologne