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
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
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
NCT ID
NCT04827251
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
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
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Effects of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease
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