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Coronary Artery DiseaseNCT04827251

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

A study testing Coffee in people with Coronary Artery Disease, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coffee
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteBrazil
Study dates
1 Sep 2022to 25 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
Show all 10Show fewer
  • 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%).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Heart Institute (InCor) / University of São Paulo

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

About this study

Official title: Evaluation of the Effect 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.

Read the 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).

Being tested
Coffee
Keywords
coronary artery disease, coffee, platelet aggregation, caffeine, aggregability
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CoffeeDietary 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).

Study groups in NCT04827251
Study groupRoleWhat they receive
Caffeinated coffeeOtherPatients 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.
Receives: Dietary Supplement: Coffee
Decaffeinated coffeeOtherPatients 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.
Receives: Dietary Supplement: Coffee

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 8 weeks (±1)

Secondary outcomes (4)

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

    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.

    Measured: 4 week (±1)

  2. Platelet aggregation evaluated by Multiplate® ADP

    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).

    Measured: 8 weeks (±1)

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

    Measured: 8 weeks (±1)

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

    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.

    Measured: 4 weeks (±1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start1 Sep 2022
  3. Primary completion25 Nov 2024
  4. Study completion25 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, open label, controlled study
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04827251
Sponsor's protocol ID
SDC 4954/19/173
Status last verified
Feb 2025
First submitted
19 Mar 2021
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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

  • Greenberg JA, Chow G, Ziegelstein RC. Caffeinated coffee consumption, cardiovascular disease, and heart valve disease in the elderly (from the Framingham Study). Am J Cardiol. 2008 Dec 1;102(11):1502-8. doi: 10.1016/j.amjcard.2008.07.046. Epub 2008 Sep 11.

    PubMed 19026304

  • Wu JN, Ho SC, Zhou C, Ling WH, Chen WQ, Wang CL, Chen YM. Coffee consumption and risk of coronary heart diseases: a meta-analysis of 21 prospective cohort studies. Int J Cardiol. 2009 Nov 12;137(3):216-25. doi: 10.1016/j.ijcard.2008.06.051. Epub 2008 Aug 15.

    PubMed 18707777

  • Lopez-Garcia E, van Dam RM, Willett WC, Rimm EB, Manson JE, Stampfer MJ, Rexrode KM, Hu FB. Coffee consumption and coronary heart disease in men and women: a prospective cohort study. Circulation. 2006 May 2;113(17):2045-53. doi: 10.1161/CIRCULATIONAHA.105.598664. Epub 2006 Apr 24.

    PubMed 16636169

  • Rosner SA, Akesson A, Stampfer MJ, Wolk A. Coffee consumption and risk of myocardial infarction among older Swedish women. Am J Epidemiol. 2007 Feb 1;165(3):288-93. doi: 10.1093/aje/kwk013. Epub 2006 Nov 16.

    PubMed 17110637

  • Happonen P, Voutilainen S, Salonen JT. Coffee drinking is dose-dependently related to the risk of acute coronary events in middle-aged men. J Nutr. 2004 Sep;134(9):2381-6. doi: 10.1093/jn/134.9.2381.

    PubMed 15333732

  • LaCroix AZ, Mead LA, Liang KY, Thomas CB, Pearson TA. Coffee consumption and the incidence of coronary heart disease. N Engl J Med. 1986 Oct 16;315(16):977-82. doi: 10.1056/NEJM198610163151601.

    PubMed 3762618

  • Andersen LF, Jacobs DR Jr, Carlsen MH, Blomhoff R. Consumption of coffee is associated with reduced risk of death attributed to inflammatory and cardiovascular diseases in the Iowa Women's Health Study. Am J Clin Nutr. 2006 May;83(5):1039-46. doi: 10.1093/ajcn/83.5.1039.

    PubMed 16685044

  • Greenberg JA, Dunbar CC, Schnoll R, Kokolis R, Kokolis S, Kassotis J. Caffeinated beverage intake and the risk of heart disease mortality in the elderly: a prospective analysis. Am J Clin Nutr. 2007 Feb;85(2):392-8. doi: 10.1093/ajcn/85.2.392.

    PubMed 17284734

  • Ding M, Bhupathiraju SN, Satija A, van Dam RM, Hu FB. Long-term coffee consumption and risk of cardiovascular disease: a systematic review and a dose-response meta-analysis of prospective cohort studies. Circulation. 2014 Feb 11;129(6):643-59. doi: 10.1161/CIRCULATIONAHA.113.005925. Epub 2013 Nov 7.

    PubMed 24201300

  • 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

  • Stefanello N, Spanevello RM, Passamonti S, Porciuncula L, Bonan CD, Olabiyi AA, Teixeira da Rocha JB, Assmann CE, Morsch VM, Schetinger MRC. Coffee, caffeine, chlorogenic acid, and the purinergic system. Food Chem Toxicol. 2019 Jan;123:298-313. doi: 10.1016/j.fct.2018.10.005. Epub 2018 Oct 3.

    PubMed 30291944

  • Olas B, Brys M. Effects of coffee, energy drinks and their components on hemostasis: The hypothetical mechanisms of their action. Food Chem Toxicol. 2019 May;127:31-41. doi: 10.1016/j.fct.2019.02.039. Epub 2019 Mar 4.

    PubMed 30844438

  • Natella F, Nardini M, Belelli F, Pignatelli P, Di Santo S, Ghiselli A, Violi F, Scaccini C. Effect of coffee drinking on platelets: inhibition of aggregation and phenols incorporation. Br J Nutr. 2008 Dec;100(6):1276-82. doi: 10.1017/S0007114508981459. Epub 2008 Apr 28.

    PubMed 18439332

  • Bydlowski SP, Yunker RL, Rymaszewski Z, Subbiah MT. Coffee extracts inhibit platelet aggregation in vivo and in vitro. Int J Vitam Nutr Res. 1987;57(2):217-23.

    PubMed 3115908

Questions about this trial

What is this clinical trial studying?

A study testing Coffee in people with Coronary Artery Disease, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Platelet aggregation evaluated by Multiplate® ASPI (time frame: 8 weeks (±1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04827251, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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