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Completed

NCT Number: NCT04827251

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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Institute (InCor) / University of São Paulo

São Paulo, 05403-000, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

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).

Primary outcomes

  1. Platelet aggregation evaluated by Multiplate® ASPI

    Time frame: 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).

Secondary outcomes

  1. Platelet aggregation evaluated by Multiplate® ADP e Arachidonic acid

    Time frame: 4 week (±1)

    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.

  2. Platelet aggregation evaluated by Multiplate® ADP

    Time frame: 8 weeks (±1)

    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).

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

    Time frame: 8 weeks (±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).

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

    Time frame: 4 weeks (±1)

    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.

Other outcomes

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

    Time frame: 8 weeks (±1)

    Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Elderly (≥65 years) and non-elderly

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

    Time frame: 8 weeks (±1)

    Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Feminine and masculine genders

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

    Time frame: 8 weeks (±1)

    Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction

  4. Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese

    Time frame: 8 weeks (±1)

    Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese

  5. Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia

    Time frame: 8 weeks (±1)

    Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia

  6. Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With of Beta-blocker and without

    Time frame: 8 weeks (±1)

    Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: With of Beta-blocker and without

  7. Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With statin and without

    Time frame: 8 weeks (±1)

    Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: With statin and without

  8. Delta change of platelet aggregation and Fraction of immature platelets (PFI)

    Time frame: 8 weeks (±1)

    Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fraction of immature platelets (PFI)

  9. Delta change of platelet aggregation and Small-LDL

    Time frame: 8 weeks (±1)

    Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Small-LDL

  10. Delta change of platelet aggregation and Fasting glycemia

    Time frame: 8 weeks (±1)

    Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fasting glycemia

  11. Delta change of platelet aggregation and Glycated hemoglobin

    Time frame: 8 weeks (±1)

    Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Glycated hemoglobin

  12. Delta change of platelet aggregation and Lipid profile

    Time frame: 8 weeks (±1)

    Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Lipid profile (total cholesterol, HDL [high-density lipoprotein], LDL [low-density lipoprotein], very low-density lipoprotein [VLDL] and triglycerides)

  13. Delta change of platelet aggregation and Lipoprotein a

    Time frame: 8 weeks (±1)

    Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Lipoprotein a - Lp(a)

  14. Delta change of platelet aggregation and Sirtuins

    Time frame: 8 weeks (±1)

    Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Sirtuins

  15. Delta change of platelet aggregation and Advanced glycation final product (RAGE) receiver

    Time frame: 8 weeks (±1)

    Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Advanced glycation final product (RAGE) receiver

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Evaluation of the Effect of Espresso on Platelet Aggregability in Patients with Coronary Artery Disease

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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