Effects of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Evaluation of the Effect of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Dietary Supplement: Coffee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 to 80 years; Coronary artery disease documented by coronary angiography; Use of aspirin 100mg. Exclusion Criteria: 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%).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, open label, controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Caffeinated coffee<br>Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, they will consume caffeinated coffee during 28 days, followed by decaffeinated coffee during more 28 days. | Dietary Supplement: Coffee<br>* 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).<br>|
| Other: Decaffeinated coffee<br>Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, they will consume decaffeinated coffee during 28 days, followed by caffeinated coffee during more 28 days. | Dietary Supplement: Coffee<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation evaluated by Multiplate® ASPI | 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). | 8 weeks (±1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation evaluated by Multiplate® ADP e Arachidonic acid | Compare the inhibition of platelet aggregation evaluated by Multiplate® ADP and Arachidonic acid after 4 weeks of caffeinated coffee consumption with platelet aggregability after 4 weeks of decaffeinated coffee consumption. | 4 week (±1) | 
| Platelet aggregation evaluated by Multiplate® ADP | Compare the inhibition of platelet aggregation evaluated by Multiplate® ADP after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period). | 8 weeks (±1) | 
| Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) 1 | Compare platelet aggregability by optical aggregometry (ADP and arachidonic acid) after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period). | 8 weeks (±1) | 
| Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) | Compare the inhibition of platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) after 4 weeks of caffeinated coffee consumption with platelet aggregability after 4 weeks of decaffeinated coffee consumption. | 4 weeks (±1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, coffee, platelet aggregation, caffeine, aggregability