Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity (ROMAN)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
|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|
- Assessment of platelet reaction units [ Time Frame: After 15 days of treatment with each drug ] [ Designated as safety issue: No ]Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California])
- Frequency of high platelet reactivity [ Time Frame: After 15 days of treatment with each drug ] [ Designated as safety issue: No ]Frequency of high platelet reactivity with the two study treatments (as defined by a Platelet Reaction Unit value>240
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Ranolazine
Patients will receive ranolazine (750 mg bid) for 15 days
os, 750 mg, twice per day, for 15 days
Other Name: Ranexa®, Gilead, USA
Active Comparator: Amlodipine
Patients will receive amlodipine (10 mg once daily) for 15 days
os, 10 mg, once daily, 15 days
Other Name: Norvasc®, Pfizer, USA
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.
|Contact: Francesco Pelliccia, MDemail@example.com|
|University La Sapienza||Recruiting|
|Rome, Italy, 00166|
|Contact: Francesco Pelliccia, MD +393483392006 firstname.lastname@example.org|
|San Raffaele Pisana||Recruiting|
|Rome, Italy, 00100|
|Contact: Giuseppe Marazzi, MD +39 335 8381320 email@example.com|
|Principal Investigator:||Francesco Pelliccia, MD||University La Sapienza, Rome, IT|