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
2014-01-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
NCT01979965
Ranolazine Implantable Cardioverter-Defibrillator Trial
NCT01215253
Study to Reduce Symptoms of Premature Beats With Ranolazine
NCT01996618
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
NCT01522651
Ranolazine in Ischemic Cardiomyopathy
NCT01345188
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients with ischemic heart disease often report multiple symptoms, including angina and palpitations.
Ranolazine is a novel antianginal and antiischemic drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury. Furthermore, ranolazine has antiarrhythmic effects which are largely a result of the drug's effect on multiple ion channels.
It has previously been shown that treatment with ranolazine can reduce the frequency of supraventricular and ventricular tachycardia in the short term. In a subgroup analysis of the MERLIN-TIMI 36 trial, the continuous ECGs of 6,351 patients were analyzed. The results showed that, in comparison with placebo, treatment with ranolazine resulted in fewer episodes of ventricular tachycardia that lasted 8 beats or longer (5.3% versus 8.3%; P \<0.001), and in fewer episodes of supraventricular tachycardia (44.7% versus 55%; P \<0.001) and new-onset atrial fibrillation (1.7% versus 2.4%; P=0.08).
It remains unknown, however, whether the favorable effects of ranolazine on symptoms and arrhythmias are maintained over time.
Purpose:
The primary objective of this study is to test the hypothesis that chronic treatment with ranolazine can improve the symptomatic status of patients with ischemic heart disease by reducing the occurrence of palpitations.
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
TREATMENT
TRIPLE
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 30 days
Ranolazine
os, pill, 750 mg, b.i.d., 30 days
Placebo
Patients will receive placebo for 30 days
Placebo
os, pill, b.i.d., 30 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ranolazine
os, pill, 750 mg, b.i.d., 30 days
Placebo
os, pill, b.i.d., 30 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
* Angiographically-proven coronary artery disease
* Stable conditions
* No recent acute coronary syndromes
* Able to understand and willing to sign the informed consent form
* Symptomatic patients (palpitation) with stable angina pectoris already on therapy with beta-blockers and/or calcium antagonists.
Exclusion Criteria
* Severe renal failure
* Severe hepatic failure
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 Sapienza
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
671/2011/D
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.