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NCT Number: NCT02108808

Effect of Ticagrelor on Fractional Flow Reserve

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.

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Key information

Conditions

Fractional Flow Reserve

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Patras University Hospital

Pátrai, Achaia, 26500, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years
  • 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.
  • Ticagrelor naive patients
  • Written informed consent

Exclusion criteria

  • History of coronary artery bypass surgery
  • Acute myocardial infarction within the previous 5 days
  • Known allergy to adenosine, ticagrelor, prasugrel or clopidogrel
  • Prior intracranial hemorrhage
  • Hemodialysis or creatinine clearance < 30ml/h
  • Moderate/severe hepatic failure
  • Active bleeding, or at increased risk of bleeding
  • Left ventricular ejection fraction <40%
  • Primary myocardial or valvular disease
  • Contraindication to adenosine
  • Angiographically visible thrombus at a target lesion, extremely tortuous coronary arteries, severely calcified lesions, left main disease, anatomy suitable for coronary artery bypass surgery
  • Previous q wave myocardial infarction in the area of target vessel
  • Severe left ventricular hypertrophy
  • Severe valvular heart disease
  • 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.

Treatment and study plan

Ticagrelor

Drug

Prasugrel or Clopidogrel

Drug

Primary outcomes

  1. % 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

Secondary outcomes

  1. % 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

  2. % 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

  3. % 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

  4. % 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

  5. % 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

Differential Effect of Ticagrelor vs Prasugrel or Clopidogrel Loading on Fractional Flow Reserve

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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