Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity (ROMAN)
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|ClinicalTrials.gov Identifier: NCT01490255|
Recruitment Status : Unknown
Verified March 2014 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was: Recruiting
First Posted : December 12, 2011
Last Update Posted : March 26, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Ranolazine Drug: Amlodipine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
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
- Assessment of platelet reaction units [ Time Frame: After 15 days of treatment with each drug ]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 ]Frequency of high platelet reactivity with the two study treatments (as defined by a Platelet Reaction Unit value>240
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): NCT01490255
|Contact: Francesco Pelliccia, MDfirstname.lastname@example.org|
|Principal Investigator:||Francesco Pelliccia, MD||University La Sapienza, Rome, IT|