Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity (ROMAN)

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Ranolazine; Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT01490255

654/2011/D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Ranolazine

Active Comparator group

Description:

Patients will receive ranolazine (750 mg bid) for 15 days

Treatment:

Drug: Ranolazine

Amlodipine

Active Comparator group

Description:

Patients will receive amlodipine (10 mg once daily) for 15 days

Treatment:

Drug: Amlodipine