Effect of Ticagrelor on Endothelial Function
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change from Baseline in Endothelial Function after 21 days of antiplatelet medication
研究概览
简要总结
This study is to assess the function of blood vessels while being treated with different types of blood thinners to determine the effect of these medications on blood vessels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Age>18 years old
- •At least two cardiovascular risk factors
- •Demonstrated endothelial dysfunction
- •Evidence of coronary artery disease
排除标准
- •Second (II) or third (III) degree heart block without a pacemaker
- •Known active pathological bleeding, history of stroke, or bleeding diathesis
- •Dyspnea classified as NYHA class III-IV
- •Need for oral anticoagulants
- •Clinically significant valvular heart disease
- •Any concurrent life threatening condition with a life expectancy less than 1 year
- •History or evidence of drug or alcohol abuse within the last 12 months
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- •History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs.
- •Latex allergy
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer Positive pregnancy test, breast feeding women or women of child bearing potential not using highly effective methods of contraception.
- •Patients who are also taking strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
- •patients taking antiplatelet medications which cannot be stopped
- •severe liver disease
研究组 & 干预措施
clopidogrel-ticagrelor
21 days clopidogrel followed by 21 days ticagrelor
干预措施: clopidogrel (Drug)
clopidogrel-ticagrelor
21 days clopidogrel followed by 21 days ticagrelor
干预措施: Ticagrelor (Drug)
ticagrelor-clopidogrel
ticagrelor for 21 days followed by clopidogrel for 21 days
干预措施: clopidogrel (Drug)
ticagrelor-clopidogrel
ticagrelor for 21 days followed by clopidogrel for 21 days
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Change from Baseline in Endothelial Function after 21 days of antiplatelet medication
时间窗: 21 days
The change in endothelial function from baseline will be assessed after 21 days of clopidogrel; the change in endothelial function from baseline will be assessed after 21 days of ticagrelor. This will be measured using RH-PAT units.
次要结局
- Acute change in endothelial function(2 hours)
研究者
Shahar Lavi
Principal Investigator
Lawson Health Research Institute