Clinical trial NCT01490255: Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: platelet reactivity
aspirin
clopidogrel
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2011-12-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Angiographically-proven coronary artery disease
* Class I indication to dual antiplatelet therapy because of recent (\<12 months) percutaneous coronary intervention and/or recent acute coronary syndrome (\<12 months)
* Stable clinical conditions
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

* Use of other drug interfering with CYP activity such as proton pump inhibitors
* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

Primary outcomes:
measure: Assessment of platelet reaction units
timeFrame: After 15 days of treatment with each drug
Secondary outcomes:
measure: Frequency of high platelet reactivity
timeFrame: After 15 days of treatment with each drug
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Raffaele Pisana
city: Rome
country: Italy
facility: University La Sapienza
Study officials:
affiliation: University La Sapienza, Rome, IT
name: Francesco Pelliccia, MD
role: PRINCIPAL_INVESTIGATOR
References: