Clinical trial NCT04827251: Effects of Espresso on Platelet Aggregability in Patients with Coronary Artery Disease
Official title: Evaluation of the Effect of Espresso on Platelet Aggregability in Patients with Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
coffee
platelet aggregation
caffeine
aggregability
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2021-04-01
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, open label, controlled study
Primary purpose: OTHER

Brief summary: 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: 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).

Eligibility criteria: 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%).

Primary outcomes:
measure: Platelet aggregation evaluated by Multiplate® ASPI
timeFrame: 8 weeks (±1)
Secondary outcomes:
measure: Platelet aggregation evaluated by Multiplate® ADP e Arachidonic acid
timeFrame: 4 week (±1)
measure: Platelet aggregation evaluated by Multiplate® ADP
timeFrame: 8 weeks (±1)
measure: Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) 1
timeFrame: 8 weeks (±1)
measure: Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid)
timeFrame: 4 weeks (±1)
Other outcomes:
measure: Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Elderly (≥65 years) and non-elderly
timeFrame: 8 weeks (±1)
measure: Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Feminine and masculine genders
timeFrame: 8 weeks (±1)
measure: Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction
timeFrame: 8 weeks (±1)
measure: Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese
timeFrame: 8 weeks (±1)
measure: Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia
timeFrame: 8 weeks (±1)
measure: Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With of Beta-blocker and without
timeFrame: 8 weeks (±1)
measure: Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With statin and without
timeFrame: 8 weeks (±1)
measure: Delta change of platelet aggregation and Fraction of immature platelets (PFI)
timeFrame: 8 weeks (±1)
measure: Delta change of platelet aggregation and Small-LDL
timeFrame: 8 weeks (±1)
measure: Delta change of platelet aggregation and Fasting glycemia
timeFrame: 8 weeks (±1)
measure: Delta change of platelet aggregation and Glycated hemoglobin
timeFrame: 8 weeks (±1)
measure: Delta change of platelet aggregation and Lipid profile
timeFrame: 8 weeks (±1)
measure: Delta change of platelet aggregation and Lipoprotein a
timeFrame: 8 weeks (±1)
measure: Delta change of platelet aggregation and Sirtuins
timeFrame: 8 weeks (±1)
measure: Delta change of platelet aggregation and Advanced glycation final product (RAGE) receiver
timeFrame: 8 weeks (±1)
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute (InCor) / University of São Paulo
state: sao Paulo
Study officials:
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