Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity
ROMAN
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
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 coronary-artery-disease
Started Jan 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 12, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 26, 2014
March 1, 2014
2.4 years
December 8, 2011
March 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Frequency of high platelet reactivity
After 15 days of treatment with each drug
Study Arms (2)
Ranolazine
ACTIVE COMPARATORPatients will receive ranolazine (750 mg bid) for 15 days
Amlodipine
ACTIVE COMPARATORPatients will receive amlodipine (10 mg once daily) for 15 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
San Raffaele Pisana
Rome, 00100, Italy
University La Sapienza
Rome, 00166, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Pelliccia, MD
University La Sapienza, Rome, IT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 12, 2011
Study Start
January 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
March 26, 2014
Record last verified: 2014-03