COMT on Aspirin Platelets Effects (CAPE)
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- platelet aggregation
研究概览
简要总结
Specific Aim I: Examine the role of genetic variation in COMT on platelet function in a blinded, randomized, placebo controlled clinical trial of daily placebo or Aspirin (81mg) for 10 ± 3 days. Platelet function will be assessed with platelet aggregometry and by fluorescence-activated cell sorting (FACS) of platelet adhesion molecules P-selectin and GPIIb/IIIa in platelets activated with arachidonic acid, thrombin, collagen, epinephrine and ADP.
Specific Aim II: Examine the effects of platelet releasates harvested at the end of each treatment arm on angiogenesis.
详细描述
This is a randomized double-blinded, placebo controlled study. This study is designed to detect the variation in platelet function based on COMT variation and how these platelets respond to cancerous cells.
We expect to recruit 60 healthy participants with the intention of studying 45 participants to complete the protocol.
Individuals aged 18 to 40 years will be eligible to participate in this study if they do not have history of fainting/problems related to blood draws, major chronic medical illnesses, regular or current treatment of Aspirin™.
Examine the role of genetic variation in in catechol-O-methyltransferase (COMT) on platelet function in a randomized double-blinded placebo controlled clinical trial of daily Aspirin™ (81 mg) versus placebo over 10-14 days. Platelet function will be assessed with a platelet aggregometry and by fluorescence-activated cell sorting assessment of platelet adhesion molecule GPIIIb/IIIa and p-selectin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, 18-40 years
排除标准
- •taking aspirin. Smoking, pregnancy, history of cancer of cardiovascular disease. Mental illness.
研究组 & 干预措施
Aspirin
Aspirin (81mg) will be taken orally daily for 10-14 days.
干预措施: Aspirin 81 mg (Drug)
Placebo
Placebo pills that are visually identical to the Aspirin pills will be taken orally, daily for 10-14 days
干预措施: Placebo (Drug)
结局指标
主要结局
platelet aggregation
时间窗: At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.
Platelets will be activated with arachidonic acid, thrombin, collagen, ADP and epinephrine
次要结局
- % expression of P-selectin on resting and activated platelets(At end of treatment 10-14 days the platelets will be activated on the same day as blood collection.)
研究者
Kathryn Tayo Hall
Assistant Professor
Brigham and Women's Hospital