Fractional Flow Reserve Clinical Trial
Official title:
Differential Effect of Ticagrelor vs Prasugrel or Clopidogrel Loading on Fractional Flow Reserve
Verified date | January 2015 |
Source | University of Patras |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Commiitee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-80 years 2. Patients subjected to clinically indicated coronary angiography with at least one 50%-90% stenosis at 1 major epicardial vessel (by visual assessment) amenable to percutaneous coronary intervention. 3. Ticagrelor naive patients 4. Written informed consent Exclusion Criteria: 1. History of coronary artery bypass surgery 2. Acute myocardial infarction within the previous 5 days 3. Known allergy to adenosine, ticagrelor, prasugrel or clopidogrel 4. Prior intracranial hemorrhage 5. Hemodialysis or creatinine clearance < 30ml/h 6. Moderate/severe hepatic failure 7. Active bleeding, or at increased risk of bleeding 8. Left ventricular ejection fraction <40% 9. Primary myocardial or valvular disease 10. Contraindication to adenosine 11. Angiographically visible thrombus at a target lesion, extremely tortuous coronary arteries, severely calcified lesions, left main disease, anatomy suitable for coronary artery bypass surgery 12. Previous q wave myocardial infarction in the area of target vessel 13. Severe left ventricular hypertrophy 14. Severe valvular heart disease 15. Heart failure as defined by New York Heart Association class III or IV 16.Hypotension (blood pressure <90 mm Hg) 17.Significant arrhythmia (e.g. excessive premature ventricular contractions or atrial fibrillation), tachycardia (heart rate >120 beats/min), bradycardia (<50 beats/min), increased risk for bradycardia 18.Caffeine consumption or cigarette smoking within the previous 24 hours. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Patras University Hospital | Patras | Achaia |
Lead Sponsor | Collaborator |
---|---|
University of Patras |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Reclassification of coronary revascularization strategy at hour 2 in relation to hour 0 | Number of patients who were reclassified regarding revascularization strategy at hour 2 in relation to hour 0, between the 2 treatment arms | 2 hours | No |
Primary | % relative change in steady hyperemia FFR (sFFR) | 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 | 2 hours | No |
Secondary | % relative change in peak hyperemia FFR (pFFR) | 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 | 2 hours | No |
Secondary | % relative change in lowest FFR (lFFR) | 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 | 2 hours | No |
Secondary | % relative change in time to peak FFR (in seconds) | (time to pFFR post drug - time to pFFR pre drug)*100/time to pFFR pre drug between the 2 treatment arms | 2 hours | No |
Secondary | % relative change in time to lowest FFR | (time to lFFR post drug - time to lFFR pre drug)*100/time to lFFR pre drug between the 2 treatment arms | 2 hours | No |
Secondary | % relative change in area under the curve (AUC) of the FFR trace | (AUC FFR post drug - AUC FFR pre drug)*100/AUC FFR pre drug between the 2 treatment arms | 2 hours | No |
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