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

NCT04827251 | Completed

• 1 other identifier: SDC 4954/19/173
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; coffee; platelet aggregation; caffeine; aggregability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Platelet aggregation evaluated by Multiplate® ADP e Arachidonic acid

  4 week (±1)

• Platelet aggregation evaluated by Multiplate® ADP

  8 weeks (±1)

• Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) 1

  8 weeks (±1)

• Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid)

  4 weeks (±1)

Other Outcomes (15)

• Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Elderly (≥65 years) and non-elderly

  8 weeks (±1)

• Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Feminine and masculine genders

  8 weeks (±1)

• Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction

  8 weeks (±1)

Study Arms (2)

Caffeinated coffee

OTHER

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

Decaffeinated coffee

OTHER

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

Interventions

Coffee 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).

Caffeinated coffee; Decaffeinated coffee

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 to 80 years;
• Coronary artery disease documented by coronary angiography;
• Use of aspirin 100mg.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Heart Institute (InCor) / University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (24)

• Adriana Farah. Coffee: Emerging Health Effects and Disease Prevention. Coffee Constituints. 2012. John Wiley & Sons, Inc. Published by Blackwell Publishing Ltd.

  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coffee

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Coronary Care Unit

Model Details: This is a prospective, open label, controlled study

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 1, 2021
• Study Start: September 1, 2022
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

BR (1)