Effect of Ticagrelor on Fractional Flow Reserve
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|ClinicalTrials.gov Identifier: NCT02108808|
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : January 6, 2015
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 μg/Kg/min for a 3 minute period) either ticagrelor 180mg loading dose or prasugrel 60mg/clopidogrel 600mg loading dose (as clinically indicated). FFR examination will be repeated 2 hours post loading dose.
|Condition or disease||Intervention/treatment||Phase|
|Fractional Flow Reserve||Drug: Ticagrelor Drug: Prasugrel or Clopidogrel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Differential Effect of Ticagrelor vs Prasugrel or Clopidogrel Loading on Fractional Flow Reserve|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Active Comparator: Prasugrel or Clopidogrel
Prasugrel 60mg or Clopidogrel 600mg loading dose, as clinically indicated
Drug: Prasugrel or Clopidogrel
Ticagrelor 180mg loading dose
- % relative change in steady hyperemia FFR (sFFR) [ Time Frame: 2 hours ]Steady hyperemia FFR (sFFR) is defined as the FFR value attained during stable hyperemia (as assessed by offline visual inspection of the 3-min hemodynamic trace) (sFFR post drug - sFFR pre drug)*100/sFFR pre drug between the 2 treatment arms
- % relative change in peak hyperemia FFR (pFFR) [ Time Frame: 2 hours ]Peak hyperemia FFR is defined as the lowest FFR measurement during the first 60 sec of adenosine infusion (pFFR post drug - pFFR pre drug)*100/pFFR pre drug between the 2 treatment arms
- % relative change in lowest FFR (lFFR) [ Time Frame: 2 hours ]Lowest FFR (lFFR) is defined as the value provided by the automated FFR console (lFFR post drug - lFFR pre drug)*100/lFFR pre drug between the 2 treatment arms
- % relative change in time to peak FFR (in seconds) [ Time Frame: 2 hours ](time to pFFR post drug - time to pFFR pre drug)*100/time to pFFR pre drug between the 2 treatment arms
- % relative change in time to lowest FFR [ Time Frame: 2 hours ](time to lFFR post drug - time to lFFR pre drug)*100/time to lFFR pre drug between the 2 treatment arms
- % relative change in area under the curve (AUC) of the FFR trace [ Time Frame: 2 hours ](AUC FFR post drug - AUC FFR pre drug)*100/AUC FFR pre drug between the 2 treatment arms
- Reclassification of coronary revascularization strategy at hour 2 in relation to hour 0 [ Time Frame: 2 hours ]Number of patients who were reclassified regarding revascularization strategy at hour 2 in relation to hour 0, between the 2 treatment arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108808
|Patras University Hospital|
|Patras, Achaia, Greece, 26500|