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

NCT ID: NCT04827251

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-11-25

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).

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, open label, controlled study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Caffeinated coffee

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.

Group Type OTHER

Coffee

Intervention Type DIETARY_SUPPLEMENT

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).

Decaffeinated coffee

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.

Group Type OTHER

Coffee

Intervention Type DIETARY_SUPPLEMENT

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).

Interventions

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Coffee

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).

Intervention Type DIETARY_SUPPLEMENT

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%).
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Jose Carlos Nicolau

Director of Coronary Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heart Institute (InCor) / University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Reference Type BACKGROUND

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Reference Type BACKGROUND

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Other Identifiers

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SDC 4954/19/173

Identifier Type: -

Identifier Source: org_study_id

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