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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

Tracking Information
First Submitted Date  ICMJE March 19, 2021
First Posted Date  ICMJE April 1, 2021
Last Update Posted Date September 7, 2022
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date December 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2021)		 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
  • 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.
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 29, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease
Official Title  ICMJE Evaluation of the Effect of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a prospective, open label, controlled study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Coffee
  • 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.
    Intervention: Dietary Supplement: Coffee
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2021)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose Carlos Nicolau, PhD 55112661-5850 jose.nicolau@incor.usp.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04827251
Other Study ID Numbers  ICMJE SDC 4954/19/173
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Jose Carlos Nicolau, University of Sao Paulo
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Sao Paulo
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP