University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
NCT Number: NCT01894789
Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial tissue. Overall benefits of one drug over the other is neutral in this generally unstable population. In pre-clinical trials, ticagrelor showed secondary effects, involving the release of adenosine to heart muscle where the demand for blood was increased due to a stress condition. Blood flow was increased, potentially preventing potential damage.
This study will compare ticagrelor, currently only approved for use in ACS patients, against clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this phenomenon. The effect on blood flow will be measurable by using two specific doses of adenosine as the pharmacologic stress and correlating with measurements of blood flow using positron emission tomography (PET) nuclear imaging.
This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Ottawa, Ontario, K1Y 4W7, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blinded administration of ticagrelor for 10 days
Other names: BrilintaTM
Blinded administration of clopidogrel and placebo for 10 days
Time frame: q 2 weeks blood flow measurements
Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure MBF. The crossover to the other study arm will occur and the study procedure repeated.
Actual study drug effect will not be known until the study has completed and the treatment unblinded.
Time frame: q 2 weeks blood flow measurements
Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure rest/stress MBF and myocardial blood flow reserve. The crossover to the other study arm will occur and the study procedure repeated.
Actual study drug effecting flow will not be known until the study has completed and the treatment unblinded.
Ottawa Heart Institute Research Corporation
Other
ComPArison of the Effect of Ticagrelor Versus Clopidogrel on Myocardial Blood Flow (MBF) and Reserve (MBFR) Measured With Positron Emission TomograpHy (PET) in Patients With Coronary Artery Disease (CAD): The PATH Study
Acronym: PATH
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