Coronary Artery Disease Clinical Trial
Official title:
Comparison of the Pharmacodynamic Effects of RanOlazine Versus aMlodipine on Platelet Reactivity in Stable Patients With Coronary Artery Disease Treated With Dual ANtiplatelet Therapy - The ROMAN Randomized Study
No previous study has assessed the potential of ranolazine to interfere with levels of
platelet reactivity in patients with coronary artery disease who are treated with dual
antiplatelet therapy.
Aim of this study is to compare the pharmacodynamic effects of maintenance doses of
ranolazine versus amlodipine on platelet reactivity in patients with coronary artery disease
who are treated with dual antiplatelet therapy.
Patients with coronary artery disease (CAD) are often treated with dual antiplatelet therapy
(DAT), including aspirin and clopidogrel, to prevent from recurrent atherothrombotic events.
Levels of platelet reactivity in patients on DAT can be influenced by concomitant treatment
with medications that inhibit the CYP3A4 system involved in the activation of clopidogrel,
such as calcium channel blockers, potentially interfering with its clinical benefits.
Importantly, calcium channel blockers, such as amlodipine, are commonly used for relief of
ischemic symptoms in patients with CAD.
Ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium
accumulation and constitutes a pharmacologic alternative to calcium channel blockade.
However, no previous study has assessed the potential of ranolazine to interfere with levels
of platelet reactivity in CAD patients on DAT.
The primary objective of this study is to compare the pharmacodynamic effects of maintenance
doses of ranolazine versus amlodipine on platelet reactivity in patients with CAD on DAT.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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