NCT00229528已完成4 期
Dose Ranging Study of the Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.
研究概览
简要总结
COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. These platelets may be important in the initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the current study is designed to determine whether paroxetine will decrease COAT-platelet production in normal volunteers and patients with cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal volunteers (without heart disease)
- •patients with heart disease
- •between ages 18 & 65
排除标准
- •children less than 18 years
- •adults greater than 65 years
- •those who can not keep appointments
- •patients within 2 weeks of a coronary catheterization
- •patients within 6 months of unstable angina or myocardial infarction
- •individuals with allergies to paroxetine or similar medications
- •individuals having adverse events to paroxetine or similar medications
- •individuals with diagnosis of mania
- •individuals with a diagnosis of hypomania
- •individuals with a diagnosis of bipolar disorders
- •individuals with a diagnosis of depression
- •individuals with a diagnosis of panic disorders
- •individuals with a diagnosis of seizure disorders
- •individuals with a history of suicide attempts
- •individuals with a diagnosis of hyponatremia
- •individuals with active bleeding disorders
- •individuals with a diagnosis of narrow angle glaucoma
- •individuals with an estimated creatinine clearance of less that 30 ml/min
- •individuals taking potentially interacting medications
结局指标
主要结局
To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.
次要结局
- To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease.
研究者
研究点 (2)
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