Effect of Ticagrelor on Fractional Flow Reserve

NCT02108808 | Completed Phase 4

• 1 other identifier: PATRAS CARDIOLOGY 18
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractional Flow Reserve

Keywords

FFR; adenosine; Ticagrelor

Outcome Measures

Primary Outcomes (1)

• % 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

Secondary Outcomes (5)

• % relative change in peak hyperemia FFR (pFFR)

  2 hours

• % relative change in lowest FFR (lFFR)

  2 hours

• % relative change in time to peak FFR (in seconds)

  2 hours

• % relative change in time to lowest FFR

  2 hours

• % relative change in area under the curve (AUC) of the FFR trace

  2 hours

Other Outcomes (1)

• Reclassification of coronary revascularization strategy at hour 2 in relation to hour 0

  2 hours

Study Arms (2)

Prasugrel or Clopidogrel

ACTIVE COMPARATOR

Prasugrel 60mg or Clopidogrel 600mg loading dose, as clinically indicated

Drug: Prasugrel or Clopidogrel

Ticagrelor

EXPERIMENTAL

Ticagrelor 180mg loading dose

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Ticagrelor

Prasugrel or Clopidogrel DRUG

Prasugrel or Clopidogrel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Patras University Hospital

Pátrai, Achaia, 26500, Greece

Location

MeSH Terms

Interventions

Ticagrelor; Prasugrel Hydrochloride; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Ticlopidine; Thienopyridines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

GR (1)