Ranolazine for Improving Symptoms of Palpitations
RYPPLE
Ranolazine for the Treatment of sYmPtoms of PaLpitations in patiEnts With Ischemic Heart Disease - The RYPPLE Trial
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
Patients with ischemic heart disease often report multiple symptoms, including angina and palpitations. Ranolazine has antiarrhythmic effects which are largely a result of the drug's effect on multiple ion channels. It remains unknown, however, whether the favorable effects of ranolazine on symptoms and arrhythmias are maintained over time. Aim 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2014
Typical duration for phase_4
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 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 20, 2011
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 7, 2013
March 1, 2013
11 months
December 15, 2011
March 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of symptoms of palpitations
Occurrence of symptoms of palpitations
Up to 30 days
Secondary Outcomes (1)
Occurrence of arrhythmia in case of symptoms of palpitations
Up to 30 days
Study Arms (2)
Ranolazine
ACTIVE COMPARATORPatients will receive ranolazine 750 mg bid for 30 days
Placebo
PLACEBO COMPARATORPatients will receive placebo for 30 days
Interventions
Eligibility Criteria
You may qualify if:
- Symptoms of palpitations
- 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.
You may not qualify if:
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours
- Severe renal failure
- Severe hepatic failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Pelliccia, MD
University Sapienza
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 20, 2011
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2016
Last Updated
March 7, 2013
Record last verified: 2013-03