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

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ClinicalTrials.gov Identifier: NCT04827251
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : September 7, 2022
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Jose Carlos Nicolau, University of Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Dietary Supplement: Coffee Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, open label, controlled study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Effect of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Dietary Supplement: 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).
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.
 Dietary Supplement: 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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827251


Contacts
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Contact: Jose Carlos Nicolau, PhD 55112661-5850 jose.nicolau@incor.usp.br

Locations
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Brazil
Heart Institute (InCor) / University of São Paulo Recruiting
São Paulo, Sao Paulo, Brazil, 05403-000
Contact: Jose Carlos Nicolau, PhD    55 11 2661-5850    jose.nicolau@incor.usp.br   
Contact: Jose Carlos Nicolau    55 11 2661-5850    jose.nicolau@incor.usp.br   
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
More Information
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Publications:
Adriana Farah. Coffee: Emerging Health Effects and Disease Prevention. Coffee Constituints. 2012. John Wiley & Sons, Inc. Published by Blackwell Publishing Ltd.
Cavalcante et al. Influência da Cafeína no Comportamento da Pressão Arterial e da Agregação Plaquetária. Arq Bras Cardiol, volume 75 (nº 2), 97-101, 2000
Dhand, N. K., & Khatkar, M. S. (2014). Statulator: An online statistical calculator. Sample Size Calculator for Comparing Two Paired Means. Accessed 7 May 2019 at http://statulator.com/SampleSize/ss2PM.html

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Responsible Party: Jose Carlos Nicolau, Director of Coronary Care Unit, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04827251    
Other Study ID Numbers: SDC 4954/19/173
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Carlos Nicolau, University of Sao Paulo:
coronary artery disease
coffee
platelet aggregation
caffeine
aggregability
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases