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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Coffee
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring coronary artery disease, coffee, platelet aggregation, caffeine, aggregability

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

  • Heart Institute (InCor) / University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Caffeinated coffee

Decaffeinated coffee

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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).
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.

Full Information

First Posted
March 19, 2021
Last Updated
May 14, 2023
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04827251
Brief Title
Effects of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease
Official Title
Evaluation of the Effect of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, coffee, platelet aggregation, caffeine, aggregability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, open label, controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caffeinated coffee
Arm Type
Other
Arm Description
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.
Arm Title
Decaffeinated coffee
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Coffee
Intervention Description
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 Outcome Measure Information:
Title
Platelet aggregation evaluated by Multiplate® ASPI
Description
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).
Time Frame
8 weeks (±1)
Secondary Outcome Measure Information:
Title
Platelet aggregation evaluated by Multiplate® ADP e Arachidonic acid
Description
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.
Time Frame
4 week (±1)
Title
Platelet aggregation evaluated by Multiplate® ADP
Description
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).
Time Frame
8 weeks (±1)
Title
Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) 1
Description
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).
Time Frame
8 weeks (±1)
Title
Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid)
Description
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.
Time Frame
4 weeks (±1)
Other Pre-specified Outcome Measures:
Title
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Elderly (≥65 years) and non-elderly
Description
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
Time Frame
8 weeks (±1)
Title
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Feminine and masculine genders
Description
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
Time Frame
8 weeks (±1)
Title
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction
Description
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
Time Frame
8 weeks (±1)
Title
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese
Description
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
Time Frame
8 weeks (±1)
Title
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia
Description
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
Time Frame
8 weeks (±1)
Title
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With of Beta-blocker and without
Description
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
Time Frame
8 weeks (±1)
Title
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With statin and without
Description
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
Time Frame
8 weeks (±1)
Title
Delta change of platelet aggregation and Fraction of immature platelets (PFI)
Description
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)
Time Frame
8 weeks (±1)
Title
Delta change of platelet aggregation and Small-LDL
Description
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Small-LDL
Time Frame
8 weeks (±1)
Title
Delta change of platelet aggregation and Fasting glycemia
Description
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fasting glycemia
Time Frame
8 weeks (±1)
Title
Delta change of platelet aggregation and Glycated hemoglobin
Description
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Glycated hemoglobin
Time Frame
8 weeks (±1)
Title
Delta change of platelet aggregation and Lipid profile
Description
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)
Time Frame
8 weeks (±1)
Title
Delta change of platelet aggregation and Lipoprotein a
Description
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)
Time Frame
8 weeks (±1)
Title
Delta change of platelet aggregation and Sirtuins
Description
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Sirtuins
Time Frame
8 weeks (±1)
Title
Delta change of platelet aggregation and Advanced glycation final product (RAGE) receiver
Description
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
Time Frame
8 weeks (±1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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%).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Carlos Nicolau, PhD
Phone
55112661-5850
Email
jose.nicolau@incor.usp.br
Facility Information:
Facility Name
Heart Institute (InCor) / University of São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Carlos Nicolau, PhD
Phone
55 11 2661-5850
Email
jose.nicolau@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Jose Carlos Nicolau
Phone
55 11 2661-5850
Email
jose.nicolau@incor.usp.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Adriana Farah. Coffee: Emerging Health Effects and Disease Prevention. Coffee Constituints. 2012. John Wiley & Sons, Inc. Published by Blackwell Publishing Ltd.
Results Reference
background
PubMed Identifier
19026304
Citation
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.
Results Reference
background
PubMed Identifier
18707777
Citation
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.
Results Reference
background
PubMed Identifier
16636169
Citation
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.
Results Reference
background
PubMed Identifier
17110637
Citation
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.
Results Reference
background
PubMed Identifier
15333732
Citation
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.
Results Reference
background
PubMed Identifier
3762618
Citation
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.
Results Reference
background
PubMed Identifier
16685044
Citation
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.
Results Reference
background
PubMed Identifier
17284734
Citation
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.
Results Reference
background
PubMed Identifier
24201300
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
30291944
Citation
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.
Results Reference
background
PubMed Identifier
30844438
Citation
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.
Results Reference
background
PubMed Identifier
18439332
Citation
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.
Results Reference
background
PubMed Identifier
3115908
Citation
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.
Results Reference
background
PubMed Identifier
2146967
Citation
Bak AA, van Vliet HH, Grobbee DE. Coffee, caffeine and hemostasis: results from two randomized studies. Atherosclerosis. 1990 Aug;83(2-3):249-55. doi: 10.1016/0021-9150(90)90170-n.
Results Reference
background
PubMed Identifier
10899090
Citation
Varani K, Portaluppi F, Gessi S, Merighi S, Ongini E, Belardinelli L, Borea PA. Dose and time effects of caffeine intake on human platelet adenosine A(2A) receptors : functional and biochemical aspects. Circulation. 2000 Jul 18;102(3):285-9. doi: 10.1161/01.cir.102.3.285.
Results Reference
background
PubMed Identifier
2977050
Citation
Ammaturo V, Perricone C, Canazio A, Ripaldi M, Ruggiano A, Zuccarelli B, Monti M. Caffeine stimulates in vivo platelet reactivity. Acta Med Scand. 1988;224(3):245-7. doi: 10.1111/j.0954-6820.1988.tb19368.x.
Results Reference
background
PubMed Identifier
30401532
Citation
Hattesen AL, Modrau IS, Nielsen DV, Hvas AM. The absorption of aspirin is reduced after coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2019 Mar;157(3):1059-1068. doi: 10.1016/j.jtcvs.2018.08.088. Epub 2018 Sep 27.
Results Reference
background
PubMed Identifier
24811298
Citation
Diffenderfer MR, Schaefer EJ. The composition and metabolism of large and small LDL. Curr Opin Lipidol. 2014 Jun;25(3):221-6. doi: 10.1097/MOL.0000000000000067.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
17447894
Citation
Michan S, Sinclair D. Sirtuins in mammals: insights into their biological function. Biochem J. 2007 May 15;404(1):1-13. doi: 10.1042/BJ20070140.
Results Reference
background
PubMed Identifier
10399917
Citation
Hofmann MA, Drury S, Fu C, Qu W, Taguchi A, Lu Y, Avila C, Kambham N, Bierhaus A, Nawroth P, Neurath MF, Slattery T, Beach D, McClary J, Nagashima M, Morser J, Stern D, Schmidt AM. RAGE mediates a novel proinflammatory axis: a central cell surface receptor for S100/calgranulin polypeptides. Cell. 1999 Jun 25;97(7):889-901. doi: 10.1016/s0092-8674(00)80801-6.
Results Reference
background
PubMed Identifier
18089847
Citation
Hudson BI, Carter AM, Harja E, Kalea AZ, Arriero M, Yang H, Grant PJ, Schmidt AM. Identification, classification, and expression of RAGE gene splice variants. FASEB J. 2008 May;22(5):1572-80. doi: 10.1096/fj.07-9909com. Epub 2007 Dec 18.
Results Reference
background

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

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