Ignite Creation Date:
2024-05-06 @ 2:02 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01957540
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2013-09-30
Brief Title:
Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease
Sponsor:
University of Patras
Organization:
University of Patras
Study Overview
Official Title:
Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
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:
None
Brief Summary:
Ticagrelor administration whose molecule resembles to adenosine led to reduction in overall mortality and thrombotic cardiovascular CV events when directly compared to clopidogrel in the PLATO trial implicating possible pleiotropic actions for the drug It has been shown that ticagrelor increases adenosine concentration by interfering with its red blood cells uptake and by inducing the release of ATP which is then converted to adenosine Recent studies in healthy volunteers and patients with coronary artery disease CAD have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration Ticagrelor administration in comparison with other P2Y12 inhibitors may influence the endothelial function as assessed by the Peripheral Arterial Tonometry method EndoPAT 2000 system Itamar Medical Caesarea Israel which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation FMD
This is prospective randomized study with a crossover design which will be conducted in patients with CAD under prasugrel maintenance dose MD 10mg once a day for at least a 3-month period At Day 0 day of randomization eligible patients will be assigned to either
Ticagrelor 90mg twice a day for the next 15 days or
Prasugrel 10mg once a day for the next 15 days At Day 0 before treatment onsetpatients wiil be subjected to a baseline peripheral arterial tonometry measurement Measurement will be repeated at Day 15 and then treatment crossover will be performed for the next 15 days without an intervening washout period At Day 30 patients will be subjected again to peripheral arterial tonometry assessment Peripheral blood sample will be taken from the patients in Day 0 for genotyping control
This is prospective randomized study with a crossover design which will be conducted in patients with CAD under prasugrel maintenance dose MD 10mg once a day for at least a 3-month period At Day 0 day of randomization eligible patients will be assigned to either
Ticagrelor 90mg twice a day for the next 15 days or
Prasugrel 10mg once a day for the next 15 days At Day 0 before treatment onsetpatients wiil be subjected to a baseline peripheral arterial tonometry measurement Measurement will be repeated at Day 15 and then treatment crossover will be performed for the next 15 days without an intervening washout period At Day 30 patients will be subjected again to peripheral arterial tonometry assessment Peripheral blood sample will be taken from the patients in Day 0 for genotyping control
Detailed Description:
None
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