Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01490255

Acronym

ROMAN

Enrollment

100

Registered

2011-12-12

Start date

2012-01-31

Completion date

2014-06-30

Last updated

2014-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

platelet reactivity, aspirin, clopidogrel

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.

Interventions

DRUGRanolazine

os, 750 mg, twice per day, for 15 days

DRUGAmlodipine

os, 10 mg, once daily, 15 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of platelet reaction units	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 \[Accumetrics, San Diego, California\])

Secondary

Measure	Time frame	Description
Frequency of high platelet reactivity	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

Countries

Italy

Contacts

Primary ContactFrancesco Pelliccia, MD

f.pelliccia@mclink.it+393483392006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026