Evaluation of the Effect of Espresso on Platelet Aggregability in Patients with Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Platelet aggregation evaluated by Multiplate® ASPI
研究概览
简要总结
Discovered thousands of years ago, coffee is among the most consumed beverages in the world. The relationship between coffee and cardiovascular risk, more specifically coronary artery disease, is controversial. Platelet aggregation and its relationship with coffee is also controversial. The investigators propose this study to evaluate the relationship between coffee and platelet aggregability in patients with coronary artery disease.
详细描述
30 patients with coronary artery disease (proven by previous coronary angiography) will be selected at the Heart Institute (InCor USP) for the study. Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, one group will consume caffeinated coffee during 28 days, followed by decaffeinated coffee during more 28 days and another group will start with decaffeinated coffee followed by caffeinated. All participants will receive "Nespresso" coffee maker "Essenza" model. The coffee "Nespresso blend voluto" will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over). The investigators will evaluate platelet aggregation by Multiplate® (ASPI, ADP and arachidonic acid) and by optical aggregometry (ADP and arachidonic acid).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 80 years;
- •Coronary artery disease documented by coronary angiography;
- •Use of aspirin 100mg.
排除标准
- •Serum creatinine dosage > 2.5 mg/dl;
- •Hemoglobin <12 g/% for men and <11 g/% for women;
- •Platelets <100,000 or >400,000/mm3;
- •Leukocytosis >12,000/mm3;
- •Fasting glycemia >126mg/dl;
- •Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) with values above the upper limits of normality;
- •Consumption of more than 30 grams of alcohol per day;
- •Active smoking or ex-smoking for less than 2 years;
- •Use of P2Y12 inhibitor;
- •Ventricular dysfunction (left ventricular ejection fraction <45%).
结局指标
主要结局
Platelet aggregation evaluated by Multiplate® ASPI
时间窗: 8 weeks (±1)
Compare the inhibition of platelet aggregation evaluated by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period).
次要结局
- Platelet aggregation evaluated by Multiplate® ADP e Arachidonic acid(4 week (±1))
- Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid)(4 weeks (±1))
- Platelet aggregation evaluated by Multiplate® ADP(8 weeks (±1))
- Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) 1(8 weeks (±1))
研究者
Jose Carlos Nicolau
Director of Coronary Care Unit
University of Sao Paulo