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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ranolazine
Amlodipine
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring platelet reactivity, aspirin, clopidogrel

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • San Raffaele PisanaRecruiting
  • University La SapienzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ranolazine

Amlodipine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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])

Secondary Outcome Measures

Frequency of high platelet reactivity
Frequency of high platelet reactivity with the two study treatments (as defined by a Platelet Reaction Unit value>240

Full Information

First Posted
December 8, 2011
Last Updated
March 23, 2014
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01490255
Brief Title
Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
platelet reactivity, aspirin, clopidogrel

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Description
Patients will receive ranolazine (750 mg bid) for 15 days
Arm Title
Amlodipine
Arm Type
Active Comparator
Arm Description
Patients will receive amlodipine (10 mg once daily) for 15 days
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa®, Gilead, USA
Intervention Description
os, 750 mg, twice per day, for 15 days
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Other Intervention Name(s)
Norvasc®, Pfizer, USA
Intervention Description
os, 10 mg, once daily, 15 days
Primary Outcome Measure Information:
Title
Assessment of platelet reaction units
Description
Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California])
Time Frame
After 15 days of treatment with each drug
Secondary Outcome Measure Information:
Title
Frequency of high platelet reactivity
Description
Frequency of high platelet reactivity with the two study treatments (as defined by a Platelet Reaction Unit value>240
Time Frame
After 15 days of treatment with each drug

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Pelliccia, MD
Phone
+393483392006
Email
f.pelliccia@mclink.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Pelliccia, MD
Organizational Affiliation
University La Sapienza, Rome, IT
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Pisana
City
Rome
ZIP/Postal Code
00100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Marazzi, MD
Phone
+39 335 8381320
Email
giuseppe.marazzi@yahoo.com
Facility Name
University La Sapienza
City
Rome
ZIP/Postal Code
00166
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Pelliccia, MD
Phone
+393483392006
Email
f.pelliccia@mclink.it

12. IPD Sharing Statement

Learn more about this trial

Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity

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