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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
Sponsor:
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Prasugrel or Clopidogrel
Prasugrel 60mg or Clopidogrel 600mg loading dose, as clinically indicated
Drug: Prasugrel or Clopidogrel
Experimental: Ticagrelor
Ticagrelor 180mg loading dose
Drug: Ticagrelor



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Locations
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Greece
Patras University Hospital
Patras, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras

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Responsible Party: Dimitrios Alexopoulos, Professor of Cardiology, University of Patras
ClinicalTrials.gov Identifier: NCT02108808    
Other Study ID Numbers: PATRAS CARDIOLOGY 18
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015
Keywords provided by Dimitrios Alexopoulos, University of Patras:
FFR
adenosine
Ticagrelor
Additional relevant MeSH terms:
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Clopidogrel
Ticagrelor
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs