NCT01490255

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Ranolazine	os, 750 mg, twice per day, for 15 days
DRUG	Amlodipine	os, 10 mg, once daily, 15 days

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2011-12-12
• Last updated: 2014-03-26

Locations

2 sites across 1 country: Italy