Evaluation of Platelet Effects of Chlorthalidone and Hydrochlorothiazide
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in mean fluorescence intensity of PAC-1
研究概览
简要总结
This will be a randomized, double-blinded, three-period crossover study of platelet activation and aggregation in 30 non-smoking healthy volunteers comparing chlorthalidone (CTD), hydrochlorothiazide (HCTZ), and aspirin (ASA; active control). The study hypothesis is that CTD has different effects on platelet activation and aggregation than HCTZ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women age 19 or older
- •Not currently taking any routinely scheduled prescription or over the counter medications or herbal supplements
- •No use of aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol, dipyridamole, NSAID medications, or herbal supplements within the previous 7 days and able to refrain from use during the study period
- •Systolic blood pressure > 110 mmHg and diastolic blood pressure > 60 mmHg
- •Non-smoker
排除标准
- •Previous adverse reaction or allergy to HCTZ, CTD, or ASA
- •Severe sulfonamide hypersensitivity (anaphylaxis or Stevens-Johnson syndrome)
- •Diagnosis of any chronic disease or condition
- •History of gout or hyperuricemia
- •History of pancreatitis
- •History of systemic lupus erythematosus (SLE)
- •History of hypokalemia requiring treatment
- •Pregnant or planning to become pregnant during the study period
- •Breastfeeding
- •History of hypotension
- •History of gastrointestinal bleeding
研究组 & 干预措施
Chlorthalidone 12.5 mg
Chlorthalidone 12.5 mg by mouth once daily for 2 weeks
干预措施: Chlorthalidone 12.5 mg (Drug)
Hydrochlorothiazide 25 mg
Hydrochlorothiazide 25 mg by mouth once daily for 2 weeks
干预措施: Hydrochlorothiazide 25 mg (Drug)
Aspirin 81 mg
Aspirin 81 mg by mouth once daily for 2 weeks
干预措施: Aspirin 81 mg (Drug)
结局指标
主要结局
Change in mean fluorescence intensity of PAC-1
时间窗: 2 weeks
The primary endpoint for this study will be the change in mean fluorescence intensity (MFI) of the platelet activation marker PAC-1 due to HCTZ, CTD, and aspirin.
次要结局
- Change in CD62P expression(2 weeks)
- Change in platelet aggregation(2 weeks)