Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity

Coronary Artery Disease Clinical Trial

— ROMAN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01490255
• Other study ID #: 654/2011/D
• Status: Recruiting
• Phase: Phase 4
• First received: December 8, 2011
• Last updated: March 23, 2014
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia, MD
• Phone: +393483392006
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Ranolazine
os, 750 mg, twice per day, for 15 days
• Amlodipine
os, 10 mg, once daily, 15 days

Locations

Country	Name	City	State
Italy	San Raffaele Pisana	Rome
Italy	University La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of platelet reaction units	Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California])	After 15 days of treatment with each drug	No
Secondary	Frequency of high platelet reactivity	Frequency of high platelet reactivity with the two study treatments (as defined by a Platelet Reaction Unit value>240	After 15 days of treatment with each drug	No