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

This study is currently recruiting participants.
Verified March 2014 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01490255
First received: December 8, 2011
Last updated: March 23, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Ranolazine
Drug: Amlodipine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Assessment of platelet reaction units [ Time Frame: After 15 days of treatment with each drug ] [ Designated as safety issue: No ]
    Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California])


Secondary Outcome Measures:
  • Frequency of high platelet reactivity [ Time Frame: After 15 days of treatment with each drug ] [ Designated as safety issue: No ]
    Frequency of high platelet reactivity with the two study treatments (as defined by a Platelet Reaction Unit value>240


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ranolazine
Patients will receive ranolazine (750 mg bid) for 15 days
Drug: Ranolazine
os, 750 mg, twice per day, for 15 days
Other Name: Ranexa®, Gilead, USA
Active Comparator: Amlodipine
Patients will receive amlodipine (10 mg once daily) for 15 days
Drug: Amlodipine
os, 10 mg, once daily, 15 days
Other Name: Norvasc®, Pfizer, USA

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490255

Contacts
Contact: Francesco Pelliccia, MD +393483392006 f.pelliccia@mclink.it

Locations
Italy
University La Sapienza Recruiting
Rome, Italy, 00166
Contact: Francesco Pelliccia, MD    +393483392006    f.pelliccia@mclink.it   
San Raffaele Pisana Recruiting
Rome, Italy, 00100
Contact: Giuseppe Marazzi, MD    +39 335 8381320    giuseppe.marazzi@yahoo.com   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Francesco Pelliccia, MD University La Sapienza, Rome, IT
  More Information

No publications provided

Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01490255     History of Changes
Other Study ID Numbers: 654/2011/D
Study First Received: December 8, 2011
Last Updated: March 23, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by University of Roma La Sapienza:
platelet reactivity
aspirin
clopidogrel

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Amlodipine
Ranolazine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014