Ignite Creation Date:
2024-05-06 @ 2:43 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02108808
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2014-04-04
Brief Title:
Effect of Ticagrelor on Fractional Flow Reserve
Sponsor:
University of Patras
Organization:
University of Patras
Study Overview
Official Title:
Differential Effect of Ticagrelor vs Prasugrel or Clopidogrel Loading on Fractional Flow Reserve
Status:
COMPLETED
Status Verified Date:
2015-01
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:
Fractional flow reserve FFR is an established invasive method for assessing the physiological significance of coronary artery stenosis Adenosine an important endogenous regulator of coronary blood flow during both stress and ischemia is widely used to achieve conditions of stable hyperemia required for measurement of FFR
Studies in healthy volunteers and in patients with acute coronary syndrome ACS post percutaneous coronary intervention PCI receiving ticagrelor revealed a differential coronary blood flow velocity response during increasing doses of adenosine compared to placebo or prasugrel treated subjects respectively It has also been demonstrated that patients treated with ticagrelor have increased plasma adenosine levels Therefore it has been hypothesized that the degree of hyperemia obtained with adenosine infusion may be greater in patients on ticagrelor than that obtained in patients taking clopidogrel or prasugrel If this proves to be true it would lead to a lower FFR value with possible important clinical implications in ticagrelor receiving patients in need for FFR measurement
This is a prospective single center randomized study of parallel design Consecutive ticagrelor naive patients who are referred for coronary angiography and have an angiographically moderate to severe de novo stenosis 50 and 90 diameter by visual assessment in at least one major epicardial coronary artery amenable to PCI are candidates for this study Patients after informed consent will be randomized hour 0 to receive immediately post FFR with adenosine iintravenous infusion at 140 μgKgmin for a 3 minute period either ticagrelor 180mg loading dose or prasugrel 60mgclopidogrel 600mg loading dose as clinically indicated FFR examination will be repeated 2 hours post loading dose
Studies in healthy volunteers and in patients with acute coronary syndrome ACS post percutaneous coronary intervention PCI receiving ticagrelor revealed a differential coronary blood flow velocity response during increasing doses of adenosine compared to placebo or prasugrel treated subjects respectively It has also been demonstrated that patients treated with ticagrelor have increased plasma adenosine levels Therefore it has been hypothesized that the degree of hyperemia obtained with adenosine infusion may be greater in patients on ticagrelor than that obtained in patients taking clopidogrel or prasugrel If this proves to be true it would lead to a lower FFR value with possible important clinical implications in ticagrelor receiving patients in need for FFR measurement
This is a prospective single center randomized study of parallel design Consecutive ticagrelor naive patients who are referred for coronary angiography and have an angiographically moderate to severe de novo stenosis 50 and 90 diameter by visual assessment in at least one major epicardial coronary artery amenable to PCI are candidates for this study Patients after informed consent will be randomized hour 0 to receive immediately post FFR with adenosine iintravenous infusion at 140 μgKgmin for a 3 minute period either ticagrelor 180mg loading dose or prasugrel 60mgclopidogrel 600mg loading dose as clinically indicated FFR examination will be repeated 2 hours post loading dose
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