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

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of the Effect of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04827251
• Other study ID #: SDC 4954/19/173
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 15, 2024

Study information

• Verified date: January 2024
• Source: University of Sao Paulo
• Contact: Jose Carlos Nicolau, PhD
• Phone: 55112661-5850
• Email: jose.nicolau[@]incor.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators propose this study to evaluate the relationship between coffee and platelet aggregability in patients with coronary artery disease.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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%).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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).

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) / University of São Paulo	São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (24)

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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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Elderly (=65 years) and non-elderly	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	8 weeks (±1)
Other	Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Feminine and masculine genders	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	8 weeks (±1)
Other	Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction	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	8 weeks (±1)
Other	Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Obese (BMI=30 Kg/m2) and non-obese	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	8 weeks (±1)
Other	Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia	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	8 weeks (±1)
Other	Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With of Beta-blocker and without	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	8 weeks (±1)
Other	Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With statin and without	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 weeks (±1)
Other	Delta change of platelet aggregation and Fraction of immature platelets (PFI)	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)	8 weeks (±1)
Other	Delta change of platelet aggregation and Small-LDL	Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Small-LDL	8 weeks (±1)
Other	Delta change of platelet aggregation and Fasting glycemia	Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fasting glycemia	8 weeks (±1)
Other	Delta change of platelet aggregation and Glycated hemoglobin	Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Glycated hemoglobin	8 weeks (±1)
Other	Delta change of platelet aggregation and Lipid profile	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)	8 weeks (±1)
Other	Delta change of platelet aggregation and Lipoprotein a	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)	8 weeks (±1)
Other	Delta change of platelet aggregation and Sirtuins	Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Sirtuins	8 weeks (±1)
Other	Delta change of platelet aggregation and Advanced glycation final product (RAGE) receiver	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	8 weeks (±1)
Primary	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).	8 weeks (±1)
Secondary	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.	4 week (±1)
Secondary	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).	8 weeks (±1)
Secondary	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).	8 weeks (±1)
Secondary	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.	4 weeks (±1)