"Potential Effect of Acute and Chronic Caffeine Administration on Platelet Reactivity in Patient With Coronary Artery Disease on Dual Antiplatelet Therapy"

NCT02054988 | Unknown

• 1 other identifier: PM3110
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Prasugrel is a potent thienopyridine antiplatelet agent that selectively and irreversibly inhibits ADP-induced platelet aggregation mediated by the P2Y12 receptor. Prasugrel is a prodrug that must first undergo biotransformation to its active metabolite via cytochrome P450-mediated hepatic metabolism (CYP1A2). Clopidogrel is currently administered to several million patients especially after coronary stenting. Clopidogrel has been shown to reduce cardiovascular complications in patients with acute coronary syndromes and patients who have undergone coronary stenting. The mechanism of action of clopidogrel's active metabolite involves inhibition of the purinergic adenosine diphosphate (ADP) receptor P2Y12 on the platelet membrane. Blockade of this receptor prevents uncoupling of the associated Gi2 protein which ultimately leads to increased platelet cyclic AMP (cAMP) formation.3 Cyclic AMP is a key signaling molecule in inhibiting platelet aggregation, but its intracellular levels are affected by several other commonly used compounds. For instance, methylxanthines, such as caffeine, theophylline, and theobromine (an ingredient of chocolate), all cause elevation of intracellular cAMP levels by inhibiting adenosine receptors (types A1 and A2) on the platelet membrane. The effect of caffeine consumption on platelet reactivity depends on the caffeine dose and duration of administration. Chronic caffeine consumption (≥7 days) appears to be associated with inhibition of platelet aggregation, probably through upregulation of adenosine receptors.The aim of this study was to examine the effect of acute caffeine consumption, at a dose equivalent to commercial coffee drinks, on the antiplatelet effect of clopidogrel and prasugrel, in patients with coronary artery disease (CAD). Platelet function will be evaluated using a validated method: the VerifyNow System (Accumetrics Inc., San Diego, CA), which is a point-of-care turbidimetry-based optical detection system that measures platelet-induced aggregation.

Conditions

CORONARY ARTERY DISEASE

Outcome Measures

Primary Outcomes (1)

• Assessment of platelet reaction units

  Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay \[Accumetrics, San Diego, California\]

  After 10 days of caffeine intake

Study Arms (2)

caffeine

EXPERIMENTAL

three cups of coffee will be administered for 10 days (on chronic phase) and two cups of coffee will be consecutively administered for "acute" evaluation.

Other: caffeine

not caffeine

ACTIVE COMPARATOR

not caffeine will be administered for the duration of the study

Other: not caffeine

Interventions

caffeine OTHER

After 5 day coffee wash-out period, patients were randomly assigned to caffeine for 10 days. At baseline: 2 cups of coffee consecutively after 5 hour by clopidogrel or prasugrel intake. Afterwards, 3 cups of coffee daily for 10 days. Platelet reactivity (expressed as P2Y(12) reaction units (PRU) by the point-of-care VerifyNow assay \[Accumetrics, San Diego, California\]) was measured at baseline and after 10-days of coffee intake.

caffeine

not caffeine OTHER

evaluate the platelet reactivity after 10 days of no caffeine intake

not caffeine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients undergone PTCA
• Patients on dual antiplatelet therapy with ASA and clopidogrel or prasugrel or ticagrelor.

You may not qualify if:

• People unable to understand and willing to sign the informed consent form;
• Smokers

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Rome, Lazio, 00166, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marina MD Polacco

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Polacco MD

CONTACT

3204093510; polamari@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

IT (1)