Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity
NCT ID: NCT01490255
Last Updated: 2014-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2012-01-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ranolazine SR in Patients With Chronic Angina Who Remain Symptomatic Despite Maximal Treatment With Amlodipine
NCT00091429
A Prospective muLticEnter Registry in chrONic coronARy synDrOme
NCT06198673
"Pharmacodynamic Comparison of Omeprazole Versus Pantoprazole on Platelet Reactivity in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy With New P2Y12 Inhibitors" -Trial dOPPLER-
NCT02028234
Pharmacodynamic Effects of Atorvastatin vs. Rosuvastatin on Platelet Reactivity
NCT01567774
Effect of Proton Pump Inhibitor on Residual Platelet Reactivity After Clopidogrel in Homogenous Genetic Strata
NCT01512953
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ranolazine
Patients will receive ranolazine (750 mg bid) for 15 days
Ranolazine
os, 750 mg, twice per day, for 15 days
Amlodipine
Patients will receive amlodipine (10 mg once daily) for 15 days
Amlodipine
os, 10 mg, once daily, 15 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ranolazine
os, 750 mg, twice per day, for 15 days
Amlodipine
os, 10 mg, once daily, 15 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Roma La Sapienza
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesco Pelliccia
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesco Pelliccia, MD
Role: PRINCIPAL_INVESTIGATOR
University La Sapienza, Rome, IT
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Raffaele Pisana
Rome, , Italy
University La Sapienza
Rome, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
654/2011/D
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.