Ignite Creation Date:
2024-05-06 @ 2:30 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02054988
Status:
UNKNOWN
Last Update Posted:
2015-06-09
First Post:
2014-01-31
Brief Title:
Potential Effect of Acute and Chronic Caffeine Administration on Platelet Reactivity in Patient With Coronary Artery Disease on Dual Antiplatelet Therapy
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Potential Effect of Acute and Chronic Caffeine Administration on Platelet Reactivity in Patient With Coronary Artery Disease on Dual Antiplatelet Therapy
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CyCLOPS
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 clopidogrels 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 formation3 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 receptorsThe 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
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
Detailed Description:
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 clopidogrels 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 formation3 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 effect of acute caffeine administration on platelet function is less clear Different studies have shown either an increase decrease or no change in platelet reactivity after acute caffeine administration 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 Platelet function will be measured with the VerifyNow P2Y12 test at baseline after 5 day wash-out period to avoid any carryover effect and after 10 days of taking caffeine
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 Platelet function will be measured with the VerifyNow P2Y12 test at baseline after 5 day wash-out period to avoid any carryover effect and after 10 days of taking caffeine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None